Konfidensielt



USE OF PALLIATIVE SURGERY IN THE

TREATMENT OF CANCER PATIENTS

The Norwegian Center for Medical Technology Assessment (SMM) Report no. 8/2003

Medical method assessment based on a review of the literature conducted by a group of experts

Preface

Palliative surgical treatment of cancer patients is considered in Norwegian Official Report no. 1997:20, Care and Knowledge: the Norwegian Cancer Plan. Among other issues, this report focuses on various treatment principles for cancer and includes a special section on palliative cancer surgery which underscores the need for more knowledge about its symptom-preventing potential and calls for a clarification of the indications for palliative surgical intervention.

The Norwegian Center for Medical Technology Assessment (SMM) was asked by the Ministry of Health and Social Affairs to conduct a review of the literature on the use and effect of palliative surgery in cancer patients. The study was conducted as an assessment of medical methods, i.e. a systematic retrieval and critical assessment according to predetermined criteria of all published and available scientific documentation.

To a greater extent, the SMM wants to include the views of patients and users. For this method assessment we invited the Norwegian Cancer Society to act as a representative of the users; their comments are included in chapter 5.3 on the ethical aspects of the use palliative surgery for cancer patients. An appendix presents their views in greater detail.

The group of experts was constituted in a meeting on 3 March 2000 and has had these members:

Chair: Professor Karl-Erik Giercksky, The Norwegian Radium Hospital, Oslo

Professor Jon Erik Grønbech, St. Olav University Hospital, Trondheim

Ass. chair of department Tor Hammelbo, Vest-Agder Hospital, Kristiansand

Senior physician Henry Hirschberg, Rikshospitalet University Hospital, Oslo

Professor Tryggve Lundar, Rikshospitalet University Hospital, Oslo

Senior physician Odd Mjåland, Vestfold Hospital, Tønsberg

Senior physician Lodve Stangeland, Haukeland University Hospital, Bergen

Professor Jon Arne Søreide, Rogaland Central Hospital, Stavanger

Senior physician Clement Trovik, Haukeland University Hospital, Bergen

Chair of section Anders Walløe, Ullevaal University Hospital, Oslo

Chair of department Rolf Wahlqvist, Aker University Hospital, Oslo Clinic of Urology

Senior physician Nicolai Wessel, Aker University Hospital, Oslo Clinic of Urology

Project coordinators: research officer Krystyna Hviding and senior research officer Lise Lund Håheim of the Norwegian Center for Medical Technology Assessment

The following were involved in an early phase of the project:

Senior physician Håkon Wæhre, Innlandet Hospital, Lillehammer

Chair of department Paal-Henning Pedersen, Haukeland University Hospital

Data on palliative surgery in Norwegian hospitals were compiled by senior adviser Øyvind Christensen and data specialist Daniel Nguyen, both of the Norwegian Patient Registry, SINTEF Unimed, and senior adviser Leena Kiviluoto, Patient Funding and Classification Unit, SINTEF Unimed.

The section of health economics is written by professor Ivar Sønbø Kristiansen and the chapter on ethical aspects by associate professor Bjørn Hofmann, both of the SMM. Contributing views from the Norwegian Cancer Society were presented by information officers Anne-Liv Hval and Anne Grasdal.

All members of the group of experts have declared that they have no competing interests or commercial or other interests related to the project that would prevent them from contributing to an assessment of the literature that is as objective a possible. The report has been approved by the SSM’s steering committee. The translation into English is done by Sveinung Løkke.

Berit Mørland Lise Lund Håheim

Director Senior research officer

Contents

1 Comments by the SMM 6

2 Introduction 10

2.1 Background 10

2.2 The group’s terms of reference 11

3 Method 14

3.1 Mode of work 14

3.2 Literature search 14

3.3 Assessment of the literature 16

4 Results 19

4.1 Gastroenterologic surgery 19

4.1.1 Dysphagia caused by oesophageal cancer 19

4.1.2 Icterus 24

4.1.3 Retention in pancreatic cancer 26

4.1.4 Retention and/or bleeding in cases of gastric cancer 27

4.1.5 Intestinal obstruction 28

4.1.6 Intestinal bleedings 31

4.1.7 Pain • quality of life • prolongation of life 32

4.2 Neurosurgery 35

4.2.1 Quality of life, neurologic deficiency /svikt/QQQ and survival in primary cancer of the brain 35

4.2.2 Neurologic deterioration and survival in brain metastasis 37

4.2.3 Neurologic deterioration in cases of metastasis to the spine 38

4.3 Orthopaedic surgery 40

4.3.1 Surgical treatment of bone metastases 40

4.3.2 Pain or fracture caused by metastases to the humerus 43

4.3.3 Pain or fracture caused by metastases to the femur 43

4.3.4 Pain or fracture caused by metastases to the pelvis 45

4.3.5 Pain or fracture caused by metastases to the spine 46

4.4 Thoracic surgery 48

4.4.1 Difficulty breathing and survival in metastasis to the lungs 48

4.4.2 Obstruction of the central airways 49

4.4.3 Stenosis/occlusion of the superior vena cava 50

4.5 Urologic surgery 51

4.5.1 Haematuria 53

4.5.2 Urinary retention 55

4.5.3 Flank pain 57

4.5.4 Metabolic disturbances from renal cancer 57

4.5.5 Vesicovaginal/intestinal fistula 58

4.5.6 Malignant ureter obstruction 58

5 Relevant assessment criteria 61

5.1 Economic aspects of palliative cancer surgery 61

5.2 Palliative cancer surgery in Norwegian hospitals 62

5.3 Ethical aspects of palliative surgery for cancer patients 64

5.3.1 The duty to help 65

5.3.2 Compassion and vulnerability 65

5.3.3 Risk and lack of knowledge 65

5.3.4 The wish to do ”everything that is possible” 66

5.3.5 Patient autonomy and information 67

5.3.6 Priorities 68

Pursuant to Norwegian Official Reports no. 18, 1997, the health services shall set priorities according to 1) severity, 2) benefits, and 3) cost efficiency. This is specified in the Patients’ Rights Act (334), from which it appears that the patient has a right to necessary help if: 1) the patient either to some extent has a worse prognosis in terms of remaining lifespan if help is delayed, and 2) the patient may have an expected benefit of the help, and 3) expected costs are in a reasonable relationship to the effect of the treatment. Incurable cancer meets the requirement of severity. For most form of palliative surgery, the benefit is either poor or undocumented. This does not necessarily imply that there is no benefit, but that the requirement of documented benefit, b), is not filled. If the benefit is not known, nothing can be said about cost efficiency; c) the costs of palliative surgery are considerable (roughly estimated at 50% of the resources in cancer surgery, cf. chapter 2.1). Solely on the basis of priority criteria, palliative surgery will not be given priority. 68

5.3.7 Research and ethics 69

5.3.8 Knowledge and ethics 69

6 Discussion 71

12 Appendixes

12.1 Search strategies

12.2 Codes for relevant hospitalisations

Comments by the SMM

Background

As a follow-up of the Norwegian Cancer Plan, the Norwegian Center for Medical Technology Assessment (SMM) was commissioned by the Ministry of Health and Social Affairs with conducting a review of the literature on the use and effects of palliative cancer surgery and palliative procedures in the domain of surgery and examine the Norwegian practice in this field.

Palliative cancer surgery is an important element in the field of palliation for cancer patients. It is considered in Norwegian Official Report no. 1997:20, Care and Knowledge: the Norwegian Cancer Plan, which has a special section devoted to palliative cancer surgery, underscoring the importance of a better knowledge basis on the effect of this treatment: “Charting the effects of palliative symptom-preventing surgery should be given priority as an important issue in the care for cancer patients in Norway.” Furthermore, reference is made to a committee set up under the Ministry of Health and Social Affairs to investigate “Surgical intervention and treatment in palliative cancer therapy” from 1996 which points out the need for registration of treatments carried out: “It is important to establish systems that over time could increase our knowledge about the impact of palliative surgery that could benefit Norwegian patients.”

The purpose of palliative cancer surgery is the relief of symptoms and the prolongation of life, not cure. Patients who need such treatment have advanced cancer; the treatment is directed towards the primary tumour, recidivation, metastases, or local and regional problems. The methods are many and the surgery can be extensive. The documentation of the treatment is of varying quality and partly deficient for several procedures that are carried out, in spite of the great extent of and need for palliative cancer surgery.

Method and approach

The terms of reference called for a critical review based on systematically identified literature. It was a considerable task; the work was devided among the five most relevant surgical subspecialties: gastroenterologic surgery, neurosurgery, and orthopaedic, thoracic and urologic surgery. Problems arising from gynaecologic cancer are mostly covered by gastroenterologists and urologists.

After a review of 3731 abstracts, 166 studies have been used, with an emphasis on patient series and a relatively few randomised controlled studies. The evidence level in the literature selected varied between the fields.

Results

Palliation of symptoms

The group of experts has focused on surgical treatment of symptoms that hinder normal bodily functions as well as other unacceptable torments. A wide variety of treatment modalities have been used; some have been superceded new methods and are no longer in use. Some main results of the review of the literature:

Surgical palliation of symptoms includes various way of relieving obstruction in the alimentary tract: in the oesophagus, the stomach, the intestines, or the cystic tract. The modalities are mainly bypass surgery, stenting or laser therapy. Stenting is increasingly used in the treatment of icterus or pruritus due to a stenosis in the cystic tract. Laser therapy can be used for obstruction or bleeding in the oesophagus and in the lower part of the colon and rectum.

Laser provides immediate relief of symptoms from obstruction in the central airways and may be combined with other therapies such as stenting and brachytherapy. Stenting has an immediate effect on obstructions in the superior vena cava to the heart.

There are many modes of treatment of symptoms that arise from cancer in the urinary bladder, prostate and kidneys. Blood in the urine due to prostate cancer or cancer of the bladder is treated with a well established surgical method. Rinsing of the bladder with a styptic solution is reasonably well documented.

Treatment of bleeding and also flank pain in cases of stenosis of the renal artery is reliably documented and has generally speaking superceded conventional surgery. Stenting can also be used in urinary retention in prostate cancer.

Pinching off of the ureter because of pressure or ingrowth of cancer tissue is now treated with ostomy of the ureter or stenting of the ureter. These methods applied for palliative purposes show documented benefit and have, in fact, replaced major urine diverting operations.

Pain is the major symptom in bone metastases; if radiotherapy does not have the desired effect, surgery may be an option. Treatment of fractures must be done with /avstivning/ QQQ so that the patient regains function as soon as possible, independently of the degree of healing.

Surgery for metastasis to the brain is beneficial for those with metastasis and an otherwise stable cancer condition. When metastasis to the spine leads to threatening palsies, treatment has to be carried out as soon as possible in order to have effect.

Prolongation of live

Some procedures have been assessed in terms of prolongation of life. There are indications to the effect that gastrectomy in incurable gastric cancer gives longer survival. Resection of a pulmonary metastasis may increase remaining lifespan. Laser has the advantage of saving lung tissue and it improves the chances of resecting metastases that are difficult to access. Resecting the tumour instead of biopsy in glioma multiforme gives longer survival; so does resecting the metastasis in addition to radiotherapy.

Palliative procedures

Our review shows that elective palliative procedures, on the basis of documented effect, may be subdivided into four main groups:

– A small number of procedures that in controlled clinical trials or large series of patients have been shown to have a reliable and measurable effect compared to other procedures. Examples included the use of laser or stenting for obstructions of the oesophagus, or surgical bypass or stenting for obstructions in the biliary ducts.

– Routinely used and often relative simple procedures, often with a high degree of at least temporary effect, that represent a therapeutic tradition introduced before controlled clinical trials became the standard. Transurethral resection for bleeding and urinary retention in cancer of the bladder and the prostate are typical examples of this type of palliative treatment. There is clearly a danger of this tradition being carried over into major procedures without palliative effect; this is illustrated by the fact that resection of a spinal disk without /avstivning QQQ is now considered to be without effect.

– The general rule is that it is difficult to document the effectiveness of symptom-free, life-extending palliative surgery (not directed towards symptoms). Still it seems clear that when optimal preoperative and perioperative staging is done, patients who may profit from such procedures may be identified. Examples of this are seen in the fields of neurosurgery and gastropancreatic surgery.

– The majority of the most common palliative procedures have a described effect, though there is not sufficiently scientific documentation as they are based on selected patient materials and retrospective comparisons. As the nature of the problems (ileus, difficulty breathing, dysphagia etc.) rarely allows untreated controls, the comparison will often be between procedures that clinically would be complementary (laser and stenting, blocking and tubing).

Relevant assessment criteria

For administrative purposes, Norway’s health services are organised in five regions. Data on registered hospitalisations in these regions have been used to throw some light on the extent of palliative cancer surgery and the resources it requires. There is no special registration of whether the surgery had a palliative or curative intention. During the 1999–2002 period, there was no overall increase in cancer surgery as a percentage (8.3%) of all surgery. The five regions had varying proportions of cancer surgery relative to all surgery, and variations by year. As regards surgical treatment of metastases, there are few such procedures in urologic surgery, but many in cancers in the alimentary tract.

Specific analyses of health economics aspects have not been carried out, though the economic aspects of palliative cancer surgery are discussed in this report. Few studies have been carried out that are suited to estimate the cost-benefit of palliative cancer surgery; hence it is difficult to give a total assessment.

Ethical issues are considered with a focus on the role of the physician, the needs of the patient, research ethics and research needs in relation to developing a basis for setting priorities. Research in this area is morally and methodically challenging. However, the paucity of high-level studies makes the knowledge basis weaker than what is called for. Palliative surgery is a potentially valuable treatment, but for patients with a short remaining lifespan, surgical treatment will not always be the best alternative for relieving symptoms. Palliative surgery requires assessments with a moral basis as well as surgical skills.

Comments

This systematic review of the literature shows that there are varying levels of evidence for many procedures in these fields. This reflects complex clinical situations in which to carry out randomised studies.

The group of experts has made a comprehensive effort and concludes that the scientific evidence presented in the available literature is inconclusive. In several areas there is a need for additional documentation. Still, in the opinion of the group of experts this review of the literature gives Norwegian cancer care a platform that could provide direction in relation to what should be the priorities in future research within this field.

As palliative cancer surgery consumes a very considerable share of the resources spent on the surgical care for cancer patients, all procedures should be registered as palliative or curative when they are coded. Compared with data from the Norwegian Cancer Registry, this would provide a new dimension for measuring the effect as well as the costs of surgical cancer care.

The present report could provide a better foundation for advice to the individual patient on whether or not the relevant treatment is of benefit to him or her in terms of improved functioning, relief of pain and other symptoms, and a better quality of life, seen in relation to the patient’s reserve of treatment options and excepted remaining lifespan. The report describes a large number of surgical treatments that to some extent are quite extensive. Patients will be in need of information on expected improvement after surgery and the disadvantages surgery may bring so that they may make a choice on whether to go through palliative cancer surgery. The lack of documentation of effect calls on the surgeon to exercise judgment in the choice of treatment in order to contribute to the treatment being a benefit for the patient.

Introduction

1 Background

Symptoms from a tumour usually occur when the organ in question is no longer able to perform its normal function or when the growing tumour for mechanical reasons causes pain or reduced functioning in adjacent organs. Metastases from the primary tumour add a new dimension to the clinical picture because the daughter tumours are often localised in other organ systems and, hence, lead to the development of other symptoms that are hard to predict. In some more rare cases, tumours make reactive products that, brought with the bloodstream, inflict functional disturbances on other organ systems.

In a relatively near future, according to the Norwegian Cancer Registry, every third person in Norway will develop a malignant disease in the course of their lifetime. Almost half of them will develop spreads QQQ or have a local recidivation of the disease; sooner or later they will be evaluated for palliative treatment. If one also takes into account the fact that a large number of primary cancer operations only have a local palliative effect and not the desired curative effect, it is evident that more than half of the surgical resources within cancer treatment are used either for purely palliative procedures or for procedures on the borderline between palliation and cure, primarily because of the fact that one still does not have exact knowledge about the real extent of the disease at the time of treatment.

Palliative surgery is one of several therapeutic modalities that are not intended to cure the patient’s cancer, but are carried out with an intention to prolong life, relieve symptoms, or prevent symptoms. One has chosen to define as necessary emergency surgery acute palliative surgery which is intended to relieve acutely occurring and severe pain or haemorrhage that cannot be relieved with optimised non-surgical or medical treatment. These issues have not been included in the selection of literature that we have assessed.

The Norwegian Cancer Plan, Norwegian Official Report no. 1997:20, Care and Knowledge (319) points out that there is evidence of effect of palliative surgery; the literature is characterised by reports based on small and selected series of patients. The Cancer Plan suggests that studies of palliative or symptom-preventing surgery should be a priority in Norwegian cancer care. Moreover, there are no international reports that satisfactorily address general issues of indication, effect, or use of resources.

Even after advanced literature searches in the field of palliative cancer, we could only identify a highly limited number of controlled studies of satisfactory quality. This was not an unexpected finding; it was the main reason why the Norwegian Cancer Plan was intended as a stimulus to better documentation of and research into palliation. Research results on palliative procedures have generally received less attention than results related to curative methods. Moreover, many will see carrying out clinical research related to palliative aims and methods as less meritorious than research aimed at cure. Various methodological problems have also been mentioned, i.e. what qualitative or quantitative criteria can or should be used, and how to measure and describe them. This is also reflected by the fact that palliative reports generally are of lower quality.

Surgery in Norway is mainly organised according to organ systems. The group of expert includes surgeons with professional backgrounds in five areas in which palliative surgery is routinely considered as an option. Palliative cancer surgery is mainly aimed at prolonging life, relieving symptoms, and preventing symptoms – and the broader, symptom-oriented concept of quality of life. The aim of the treatment is not, as in curative surgery, total resection of the tumour. This may be self-evident; still it is an important realisation that the group of experts thinks make it easier to compare various procedures. It could also provide a required framework for future cost analyses.

2 The group’s terms of reference

The group of experts shall systematically and critically assess the documentation of palliative surgical interventions in the treatment of cancer patients

The following issues shall be in focus:

• Effect – Effect of surgical intervention with palliative intention in terms of prolonging life, relieving symptoms and preventing symptoms. The effect of surgical intervention shall also be assessed in relation to the best supportive care and in relation to alternative therapeutic modalities in those cases when this is relevant.

• Consequences – Even though an assessment of methods primarily focuses on clinical aspects, ethical and economic issues shall also be discussed. The use of palliative surgery shall be assessed in the framework conditions of the Norwegian health services.

• Definition and clarification of the terms of reference – Palliative surgery implies a surgical treatment in which the objective is not cure, but to prolong the patient’s life and prevent or alleviate the patient’s symptoms (NOU 1997:20; 319). The committee is called upon to focus its report on elective surgery defined as follows: palliative surgical interventions that may be postponed for more than 24 hours; palliative surgical interventions in emergencies shall be excluded. “Grey zone” cases shall be discussed in the context of theme. The balance between positive effect and negative effect (complications/death) is interesting and important.

Definition/clarification of the matter under assessment

There are many grey zones in therapies that may be curative and palliative at the same time. The main focus in this report is on the treatment of symptoms that are so distressing that non-emergency surgery is assumed to give the best palliation or prolongation of life. Therapeutic modalities that strictly speaking are not surgical but which are part of the surgeon’s responsibilities (for example, stenting) are included.

The clinical course of a cancer patient (figure 3.1) is a result of several factors and the need for palliative treatment may arise at various stages in the chain of treatments. We accentuate three relevant situations in which palliative treatment is an option for patients in advanced stages of cancer:

I. The patient may have had surgery, but has been found inoperable with a curative intention or found incurable without surgery. Surgical palliative treatment could be an option in order to alleviate symptoms or prolong life, for example in advanced prostate cancer.

II. The patient is in need of palliative surgery because of metastasis, for example treatment of a bone fracture caused by bone metastases, in order to keep the function intact.

III. The patient has distressing symptoms from his or her primary tumour and has to have a resection in order to function, for example in cases of obstruction in the central airways caused by cancer.

Figure 3.1. Various clinical courses

[pic]

| |Primary operable |Potentially curative|Cured |Absolutely curative,|No surgery |

| |(curative intention)|surgery | |R0 | |

|New patient | |Incurable |Recidivation |R1/R2 resection |Tumour-oriented |

| | |disease/resection of| | | |

| | |primary tumour | | | |

| | |Incurable |Not tumour-oriented |No surgery |Not tumour-oriented |

| | |disease/not | | | |

| | |tumour-oriented | | | |

| | |surgery | | | |

| | |“Open and shut” |Tumour-oriented |Surgery | |

| | |cases | | | |

| |Inoperable |Other factors | | | |

| | |(general condition | | | |

| | |etc.) | | | |

| | |Tumour-related | | | |

| | |factors | | | |

The task at hand was limited to the following fields:

• Gastroenterologic surgery: surgery related to the alimentary tract from the oesophagus to the rectum that improves functions, reduces pain or stops bleedings.

• Neurologic surgery: surgery because of primary tumour or metastasis to the brain or the spine/spinal medulla in order to preserve neurologic functions.

• Orthopaedic surgery: surgery related to pain and/or fractures or required reinforcements of arm, leg or spine due to bone metastases.

• Thoracic surgery: surgery on metastases in the lungs, reduction of compression of the superior vena cava and procedures and keeps the airways open.

• Urologic surgery: surgery related to the urinary tracts in order to provide passage from the kidneys to the urinary bladder, facilitate voiding of the bladder, and stop bleedings.

Method

1 Mode of work

The group of experts worked in sections organised by field: gastroenterologic, neurologic, orthopaedic, thoracic and urologic surgery. The urologic surgery group was reorganised when one member left and a new member was appointed in the middle of the project period. Work on gynaecologic surgery was started but not carried on, mainly because palliative procedures for all practical purposes are directed towards the urinary tracts and the digestive channel and are considered in the relevant sections.

The project manager organised the literature search according to the group’s terms of reference and the plan for the project. Abstracts were retrieved and submitted to the group members.

2 Literature search

Criteria for inclusion:

Interventions

– surgical intervention with palliative intent directed towards the primary tumour

– surgical intervention with palliative intent directed towards metastases

– not tumour-related surgical palliative intervention

Population

– patients to be treated with surgical intervention with a palliative intention

Study design

– What is under review is the effectiveness of surgical interventions in palliative treatment of cancer patients; hence clinically controlled studies should constitute the backbone of the review. If possible, these should be

– meta-analyses of randomised controlled trials

– randomised controlled trials

The following other types of studies with a lower quality may also be included:

– controlled trials of good quality (controlled study with pseudo-randomisation, non-randomised controlled study (cohort), case-control study)

– register data

– patient series

Review articles are included in the literature search only in order to retrieve data from lists of references.

– Measures of effectiveness

– Life-prolonging treatment: prolonged lifespan, either absolutely (months, weeks), or relative improvement in percentage terms.

– Symptom-preventing treatment: delayed time to onset of symptoms/recidivation. (The measure of effectiveness here will be time from start of treatment to onset of symptoms.)

– Symptomatic treatment: reduction of troublesome symptoms, cited as degrees of symptom relief, the proportion of patients with palliation and the duration of this effect. This may to some extent also be measured and objectivised, for instance by use of instruments for measuring quality of life or functional status.

Languages

– Articles whose quality and relevance may be assessed on the basis of abstracts in one of these languages: English, German, French, the Scandinavian languages

Time period

– Articles from 1966 and onwards

Criteria for exclusion:

Interventions

– surgical intervention with a curative intention

– emergency surgery

– undocumented experimental modalities

Population

– children were not included

Study design: Seen as irrelevant were case histories or anecdotes, expert comments, consensus reports, clinical trials of poor quality (e.g. lack of controls, too few patients in relation to the relevant problem etc.) Consensus reports could, however, be useful for ethical assessments.

Articles that only deal with curative treatment were not included. Survival results are cited from included articles that also report data on palliative effect. Only results that are relevant from a palliative perspective on cancer surgery are cited; hence results from all patient groups in an article are not necessarily cited.

Search strategy

These bibliographic databases were used:

• Medline (1966–2000)

• HTA database (1992–2000)

• Cochrane Library:

Cochrane Database of Systematic Reviews (CDSR)

Cochrane Controlled Trials Register (CCTR)

• Database of Abstracts of Reviews of Effectiveness (DARE)

• Embase (1974–2000)

• NHS Economic Evaluation Database

• Cancerlit

Lists of references in relevant article were reviewed in order to identify relevant publications that were not identified through database searches.

Systematic searches were conducted for each field. Initially a general search was done for advanced disease and palliative surgery for the various cancer diagnoses. This was too unspecific, as treatment aimed at survival was prevalent and the palliative perspective less pronounced. The report is therefore based on searches in which specific symptoms with a need for palliation were linked to advanced stage of the cancer in question. This compilation was then seen in relation to specific surgical methods. For search strategy, see chapter 12.1, search strategy. QQQ

This search strategy was used for a final updating search conducted 1 January 2003 for randomised studies, meta-analyses and systematic reviews of all the five subspecialties. The assessment of this literature was finalised on 28 February 2003.

3 Assessment of the literature

Stage 1 included reading of abstracts that were identified through the searches. Each group had two or three experts. They read and assessed the abstracts independently of each other (table 3.1) and submitted their results to the project manager. Included in the number of articles for orthopaedic surgery are articles that were assessed jointly with the neurosurgeons and were related to metastases to the spine.

Table 3.1. Stage 1: Number of abstracts read by each specialist group

| |Total no. of |Gastro- |Neuro- |Ortho- |Thoracic |Urologic |

| |articles |enterologic |surgery |paedic |surgery |surgery |

| |of | | |surgery | | |

| |articles | | | | | |

|Assessed, |3731 |1716 |462 |277 |480 |796 |

|total | | | | | | |

|Assessed at stage |871 |365 |86 |163 |90 |167 |

|2 | | | | | | |

|Assessed at stage |320 |104 |20 |64 |37 |95 |

|3 | | | | | | |

|Excluded at stage |157 |38 |12 |21 |18 |68 |

|3 | | | | | | |

|Included at stage |163 |66 |8 |43 |19 |27 |

|3 | | | | | | |

For stage 2, articles selected on the basis of abstracts were retrieved. Articles that did not meet the criteria for inclusion were excluded at this stage (table 3.1). The experts decided on exclusion according to these criteria:

• Was the study design irrelevant?

• Was the patient group irrelevant?

• Was the intervention badly described?

• Were the endpoints not clearly defined?

• Was the study inadequately performed?

At stage 3, each article was thoroughly assessed for inclusion in the basis of literature (table 3.1). The articles were discussed in plenary sessions and notes taken on special types of information considered relevant in each article. Notes were also taken of statistical methods used and authors’ conclusions. The articles were checked for internal validity according to check lists for randomised trials, case-control studies and cohort studies; they were ranked (table 3.2) and assigned an evidence level (table 3.3). Total evidence level (table 3.4) varied among the fields of surgery.

Articles at stage 3 were excluded because of weak validity; they might also be excluded from the basis of evidence at this stage if the method was badly described or serious bias was not explained. A list was made of these articles with specification of the reason for exclusion (chapter 10).

It was known in advance that there was a limited number of controlled studies (evidence level 1 or 2) in the field, hence articles at evidence level 3 were also included in order to develop a survey of the literature available for the wide range of surgical procedure for which an assessment of effectiveness was relevant; hence, best evidence of effectiveness will be at different levels among the fields. For some therapeutic modalities there were only small patient series or pilot studies and we cannot give a total assessment of the total evidence level in this review.

Table 3.2. Ranking based of total assessment of quality

|Rank |Criteria |

|++ |Used if all or most criteria in the check list are filled; if the criteria are not filled: there is a high |

| |probability that the conclusions from the study or survey would not change |

|+ |Used if some criteria in the check list are filled; if the criteria are not filled or not adequately described: |

| |if the conclusions from the study or survey would probably not change |

|- |Used if few or none of the criteria in the check list are filled; if the criteria are not filled or not |

| |adequately described: if the conclusions from they study or survey would be expected to change |

Table 3.3. Study types and study quality

|Level |Study types and study quality |

|1++ |Very good meta-analysis, systematic survey of randomised controlled trials (RCT) or RCTs with very little risk|

| |of bias |

|1+ |Well conducted meta-analysis, systematic survey of RCT or RCT with little risk of bias |

|1- |Meta-analysis, systematic survey of RCT or RCT with great risk of bias |

|2++ |Very good systematic survey of case-control or cohort studies with very little risk of confounding factors, |

| |bias or coincidence and a high probability that the claimed association is real |

|2+ |Well conducted case-control or cohort studies with little risk of confounding factors, bias or coincidence and|

| |a moderate probability that the claimed association is real |

|2- |Case control or cohort study with a high risk of confounding factors, bias, or coincidence and a significant |

| |risk that the claimed association is not real |

|3 |Not controlled studies (with an element of comparison), register studies, patient series |

|4 |Statements by experts, descriptive studies, case reports |

Results

1 Gastroenterologic surgery

Introduction

Palliative surgery addresses symptomatic problems and their amelioration. The volume of abdominal surgery seen relation to incidence and median survival is presented by averages for the 1996–2000 period (table 4.1.1).

Table 4.1.1 Survey of the main groups of gastrosurgical cancer in Norway

|Organ |No. per year1 |Operated2 |Median survival3 |

|Oesophagus |160 |19% |Operated: 9 months |

| | | |Not operated: 9 months |

|Ventricle |650 |36% |Operated: 18 months |

| | | |Not operated: 7 months |

|Pancreas |590 |9% |Total 7 months |

|Colon |2090 |>90% |Dukes A–C: >5 years |

| | | |Dukes D: 8 months |

|Rectum |1000 |>90% |Dukes A-C: >5 years |

| | | |Dukes D: 11 months |

1 Average incidence 1996–2000. Norwegian Cancer Registry: Kreft i Norge 2000. Rounded off to 10.

2 The proportion of resections is the average of resection procedures 1999–2001, Norwegian Patient Registry, SINTEF Unimed, in relation to the average incidence 1996–2000.

3 Estimated values from five-year survival curves. Norwegian Cancer Registry: Kreft i Norge 1999.

Below we start with symptoms related to functions in the digestive tract and its adjacent organs that can be alleviated by gastroenterologic surgery:

1. Dysphagia caused by oesophageal cancer and in some instances tumours/metastases that put pressure on the oesophagus from the outside.

2. Icterus caused by a mechanical pinch on the biliary tracts.

3. Retention (poor or no passage from the stomach to the small intestine) caused by cancer in distal biliary ducts, pancreas, or the stomach.

4. Intestinal obstruction/ileus caused by stenosis or obstruction or pinch on the intestinal tract.

5. Intestinal bleeding caused by bleeding from the gastrointestinal tract.

6. Pain • Quality of life • Survival

1 Dysphagia caused by oesophageal cancer

Each year about 160 new cases of oesophageal cancer are diagnosed in Norway. These are often older patients (70+) who not infrequently have comorbidity /ledsagende sykdommer QQQ that are of decisive importance in relation to the choice of relevant treatment.

Dysphagia could be a symptom of cancer of the oesophagus or in the cardia. Patients with cancer of the oesophagus and dysphagia at the time of diagnosis are often in an advanced stage of the disease, hence the prognosis is often very serious; total five-year survival is estimated at 5–10%. Surgical treatment with curative intention could be an option for a small proportion of these patients (approx. 20%). The others will often be in need of palliative treatment in order to obtain improved oesophageal functioning.

The aim of palliative treatment in this setting is to help the patient to achieve an oesophageal function that enables normal intake of fluids and nutrition. At the same time, the procedure-related rate of complications must be low and the procedure should give as little discomfort for the patient as possible.

Available palliative methods include:

• Surgical treatment

• Laser therapy

o Laser versus injection

o Laser versus intubation

o Laser versus photodynamic treatment

• Endoscopic intubation: rigid tube versus self-expanding stent

• Oncologic non-surgical modalities together with surgical palliative procedures

We have not identified relevant studies according to the above criteria, studies of comparable modalities such as bipolar coagulation or argon plasma coagulation. Furthermore, we have not identified studies that compare palliative surgical treatment with purely palliative radiotherapy and/or chemotherapy. Such treatment has, however, not infrequently been given to some of the patients who, in the studies we have evaluated, have been given surgical or non-surgical treatment, a fact that complicates the assessment of treatment effect.

It is a debatable point whether all these methods are “surgical”; in many countries there are often other specialists (medical gastroenterologists, dedicated units for endoscopy, interventional radiologists etc.) that use such therapeutic modalities. In Norway, these patients are by and large treated by surgeons. We still found it appropriate to include these alternatives in this literature review. The methods all have their advantages and disadvantages; below we give an account of the scientific evidence.

Few good prospective studies (RCTs) have been published within the field of gastroenterologic palliative cancer surgery. In this literature search, only five such studies were identified (2,4,11,50,68); we have also assessed a prospective controlled study (29) that focuses on palliative treatment of dysphagia. By and large the literature can be classified as in the table below:

|Symptom |Type of cancer |Treatment |Reference |Evidence level |

|Dysphagia |Cancer of the |Surgery |47 Segalin |3 |

| |oesophagus | | | |

| | |Laser therapy |2 Alderson |1 |

| | | |11 Carter |1 |

| | | |29 Loizou |1 |

| | | |1 Ahlquist |2 |

| | | |54 Spinelli |3 |

| | | |7 Barr |3 |

| | | |12 Carter |3 |

| | | |32 Naveau |3 |

| | | |37 Paolucci |3 |

| | |Intubation/ stenting |50 Siersema |1 |

| | | |68 Adam |1 |

| | | |67Knyrim |2 |

| | | |14 Cowling |3 |

| | | |47 Segalin |3 |

| | | |15 Cwikiel |3 |

| | | |35 O’Sullivan |3 |

| | |Oncologic treatment |No relevant | |

| | |and surgery |literature | |

Surgery

A retrospective study (47) reports the results after palliative resection of tumour tissue and surgical by-pass; results after intubation and laser treatment are also reported by the same centre. Severe complications after palliative surgery for cancer of the oesophagus were frequent, with mortality above 20% after palliative by-pass surgery. The same authors also cite mortality above 10% after intubation. The rate of complications is above 30–40% after various palliative procedures.

Palliative procedures lead to considerable morbidity and mortality, a fact that underscores the need for alternative, non-surgical modalities for this group of patients with disabling dysphagia and with a severe prognosis.

Laser therapy

Three randomised studies compare endoscopic laser treatment with, on the one hand, injections with polidocanol, a cytotoxic agent (4), intubation with latex tubes (2,11), or the use of self-expanding stents (68). The fifth study compares latex tubes with self-expanding stents (50). The studies are by and large small ( ................
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