ࡱ> bdaZ;bjbjyy4r.2+b b 84('''''''$!*,(-JJJ(=(8&8&8&J&'8&J'8&8&8&*5p$8&'S(0(8&-$-8&8&-&8&_|o((%d(JJJJ-b  :Prospective study of preoperative full MRI evaluation vs. standard preoperative evaluation in patient with rectal cancer Study goals and objective To investigatethe quality ofpreoperativeevaluationin patients with rectal cancer, either as a full MR imaging (MRI) with MR rectum+MR colonography +MR liverandchestCTversuscurrent standard preoperativeevaluation (MR rectum+endoscopy+abdominal/chest CT). Furthermore,to assess the economicaspects of fullpreoperative MRIevaluation vs.standard preoperativeevaluation in patients with rectal cancer. Background Colorectalcancer (CRC) is among themost commoncancer formsin Denmark withan approximate of4300new cases inDenmarkannually, of which rectalcancerrepresents approximately1400new cases each year [1].It is alsowell known thatsynchronouscancerand polypsare present in up to 11%and 58%in patients withCRC[2, 3, 4, 5, 6bv].It is assumed that adenomas constitute a precursor for cancer [7] and it is thus speculatedthat thedetectionand removal of adenomascouldreduce the incidence andmortality of colorectal cancer.Danish Colorectal Cancer Group (DCCG) and the Danish Surgical Society (DKS) currently recommend full colonic investigation as part of the preoperative evaluation, which also includes MRI ofthe rectum, ultrasoundof the liver andchest X-ray(orabdominal/chest CT)to locatepossible metastasis orsynchronoustumors [8]. However, it isoftendifficult to implementthe preoperative colonic investigation due tolack of capacityor tumor stenosis. A recentDanish studyshowedthat upto 78% of all patients with colorectal cancer had not received the fullcolonic investigation preoperatively[9].In this instance, the recommendationfromDCCG&DKSisthat patients,in the absence ofcompletecolonic investigation preoperatively,shouldundergo colonoscopywithinthree monthspostoperatively. Within thelast 15years newnon-invasive imaging techniques have been developed, this includes MR colonography(MRC). Likeconventionalcolonoscopy, MRC requires bowel cleansing, sincefecescan createartifacts that can hideor mimic polyps and abnormalities. Aftercolonic cleansingthe colonis distended by water using a rectal catheter.Since it is only waterthat needs to pass througha possibly stenotic colon segment, there isa better chance to successfully examine the entirecolon compared toacolonoscopy.A recent study showeda 98% success rate usingMRC to examine the entirecolonin patients with CRC having colon stenosis[10].The MRC is preformed after the colon isfully distendedwith water and the scan times are between 10 and15 minutes.Data processing, reconstruction and analysis are made at an independent workstation. The advantages ofMRCare itsnon-invasivenature, short examination time, andthe fact that sedationis unnecessary. This makes it possible for patients tobe discharged directly afterthe imaging procedure as opposed to the necessity for admission after a colonoscopy until the effects of the sedative drugs have worn off.Furthermore,it is assumed that patientcomplianceis much higher in MRC, since the majority of the patients findit less unpleasantthancolonoscopy[11, 12]. MRIof the liveris a well-knownprocedurethat hasshown good results in the diagnosisof hepatic metastasesand primarycancers.Several studies have shownthat itisequalor betterthanCT and ultrasoundof the liver[13,14]. Currentlythere are nostudies,whichmakethe overall preoperativeassessment by means of one investigating technique,namely MRI.We have previouslystudiedthe sensitivity/specificityand patient satisfaction byMRC withfecaltagging[15]. In this study we want to investigate the quality of MRC with bowel cleansing, also assessing the economic aspects of an overall examination of the rectum, colon and liver in patients with rectal cancer. Design Prospective randomized clinical trial. Patients diagnosed with rectal cancer are invited to participate in a full preoperative MRI investigation (rectum, liver ad colonography) + chest CT or to participate in the standard preoperative evaluation (rectal MRI, +/- endoscopy and abdominal/thoracic CT) to exclude metastasis. The randomization is computerized. The studiesare evaluated by two blinded investigators. All patients will also receive an intraoperative ultrasound of the liver, which will serve as the gold standard for liver examination. Study population: 140 patients with histopathological confirmed rectal cancer, scheduled for surgery. Inclusion criteria: Patients with rectal cancer scheduled for surgery. Exclusion criteria: Missing informed consent IBD (Inflammatory bowel disease) Pacemaker Metal parts in the body Claustrophobia Psychiatric disorders Age under 18 Pregnancy Kidney diseases Heart disorders (i.e. arrhythmia) Methods: Patients scheduled for surgery after histology confirmed rectal cancer are invited to participate in the study after obtaining an informed consent. After acceptance patients are randomized by a computer generated randomization code, to either receive the full preoperative MRI evaluation (rectum, liver ad colonography) + chest CT or to participate in the standard preoperative evaluation. The patients are randomized in blocks of groups of 10 patients. Both groups will also receive an intraoperative ultrasound of the liver, which will serve as the gold standard for liver examination. After the first 140 patients are included in the study, additional participants will be included in blocks of 10 ifpatientshave dropped out ofthe study. This will ensure that the overall enrolled number of patients who have completed the project will be at a minimum of 140. The day before the full MRI investigation, patients have to carry out a colonic cleansing, following the guidelines of bowel cleansing with Moviprep. The patients not included in the study will receive the standard preoperative evaluation. During the procedure the patient is placed in supine position, where a rectum scan will be performed followed by a liver scan. Hereafter, the colon will be distended with water by a rectal catheter and the remaining scans will be conducted. Each of the MRC scan sequences are about 20 sec. with patient breath hold during each sequence. MRI contrast agent is administered to emphasize pathology in the T1 MR imaging. Furthermore, patient will be administered intravenously Buscopan, to reduce bowel movement and thus imaging artifacts. Data processing, reconstruction and analysis are made at an independent workstation. Safety Considerations: Department guidelines are followed. Monitoring for MRI scanning with contrast is performed by radiology technicians and there will be an immediate access to a radiologist in necessary cases. Patient recruitment: Patients will be recruited in Gastroenheden, surgical gastroenterology section, Herlev University Hospital, as a part of their first outpatient visit after having the cancer diagnosis confirmed. The patient will be contacted directly by research year student Talie HadiKhadem or another member of the research group. Informed consent: All potential study participants will receive oral and written information about the study. Inclusion takes place after obtaining informed consent. Risks and side effects: The MRI contrast agent (Gadolinium) is used in daily routine MRI scans and is administered intravenously. Side effects are extremely rare and may present as warmth, a metallic taste in the mouth, palpitations, headaches and dizziness associated with the injection and in rare cases hives and nausea. Buscopan is also a common agent used in clinical routine practice such as endoscopy with rare side effects. Known side effects are dry mouth, pupil dilation, mucosal dryness, heart palpitations and urinary retention. Moviprep is a routine bowel cleansing agent with extremely rare side effects. These includes bloating, nausea; rectal irritation; stomach cramps or pain, vomiting, muscle pain, shivering, diarrhea and dizziness. There is a possibility of scanner induced loud noises during MRI scanning. Patients will be offered a hearing protection device. There is always a radiologist in the immediate vicinity during the MRI scans. The scans will take place at the Radiology department at Herlev University Hospital. Ethical aspects: A full preoperative MRI evaluation has potentially enormous consequences for investigation and diagnosis in patients with colorectal cancer. There are many expected advantages compared to the existing diagnostic tools (as mentioned above) in this procedure if validated and developed. This applies both to the patient but also on a socioeconomic perspective. During the study, project subjects will receive a more extensive diagnostic investigation. The expected beneficial effects of the project, both for the individual patient and for future patients, thereby justify the studies predictable risks, side effects and disadvantages. Statistics: Sample size is calculated to be 50 patients in a group to ensure at least 1 synchronous cancer in each group with a 95% likelihood, assuming that the prevalence of synchronous cancer is 6%. To further strengthen the study the number is increased to 75 patients in each group. Logistical framework: The project will be performed at the Department of Radiology and Gastroenheden, Herlev University Hospital. Approval: The project has been approved by the Regional Ethics Committee and the Danish Data Protection Agency. Time frame: The project is intended to have a time span of 48 month. Support: The project is thought to be a continuation of part of Ph.D thesis by Michael Achiam "Clinical Aspects of MR Colonography as a Diagnostic Tool" on the initiative of Michael Achiam, Jacob Rosenberg and Henrik Thomsen. No one in the project group has economic interests in the project and patients will not be accommodated economically.  ADDIN REFMGR.REFLIST Reference List 1. Cancerregisteret 2005 og 2006. Nye tal fra Sundhedsstyrelsen, 2008 2. Adloff M, Arnaud JP, Bergamaschi R, Schloegel M. Synchronous carcinoma of the colon and rectum: prognostic and therapeutic implications. Am.J.Surg. 1989; 157 (3):299-302 3. Cunliffe WJ, Hasleton PS, Tweedle DE, Schofield PF. Incidence of synchronous and metachronous colorectal carcinoma. Br.J.Surg. 1984; 71 (12):941-943 4. Isler JT, Brown PC, Lewis FG, Billingham RP. The role of preoperative colonoscopy in colorectal cancer. Dis.Colon Rectum 1987; 30 (6):435-439 5. Langevin JM, Nivatvongs S. The true incidence of synchronous cancer of the large bowel. A prospective study. Am.J.Surg. 1984; 147 (3):330-333 6. Nikoloudis N, Saliangas K, Economou A, Andreadis E, Siminou S, Manna I, Georgakis K, Chrissidis T. Synchronous colorectal cancer. Tech.Coloproctol. 2004; 8 Suppl 1:s177-s179 7. Leslie A, Carey FA, Pratt NR, Steele RJ. The colorectal adenoma-carcinoma sequence. Br.J.Surg. 2002; 89 (7):845-860 8. DCCG og Dansk Kirurgisk Selskab. Diagnostik og behandling af kolorektal cancer, 2005 9. Achiam MP, Burgdorf SK, Wilhelmsen M, Alamili M, Rosenberg J. Inadequate preoperative colonic evaluation for synchronous colorectal cancer. Scand.J.Surg. 2008 (In Press) 10. Achiam MP, Logager VB, Chabanova E, Eegholm B, Thomsen HS, Rosenberg J. Diagnostic accuracy of MR colonography with fecal tagging. Abdom.Imaging 2008; 11. Florie J, Birnie E, van Gelder RE, Jensch S, Haberkorn B, Bartelsman JF, van dS, V, Snel P, van dH, V, Bonsel GJ, Bossuyt PM, Stoker J. MR colonography with limited bowel preparation: patient acceptance compared with that of full-preparation colonoscopy. Radiology 2007; 245 (1):150-159 12. Hartmann D, Bassler B, Pfeifer B, Eickhoff A, Weickert U, Riemann JF, Layer G. Patient acceptance of magnetic resonance colonography: a prospective inquiry for comparison to conventional colonoscopy. Dtsch.Med.Wochenschr. 2006; 131 (45):2519-2523 13. Kim YK, Ko SW, Hwang SB, Kim CS, Yu HC. Detection and characterization of liver metastases: 16-slice multidetector computed tomography versus superparamagnetic iron oxide-enhanced magnetic resonance imaging. Eur.Radiol 2006; 16 (6):1337-1345 14. Rappeport ED, Loft A, Berthelsen AK, von der RP, Larsen PN, Mogensen AM, Wettergren A, Rasmussen A, Hillingsoe J, Kirkegaard P, Thomsen C. Contrast-enhanced FDG-PET/CT vs. SPIO-enhanced MRI vs. FDG-PET vs. CT in patients with liver metastases from colorectal cancer: a prospective study with intraoperative confirmation. Acta Radiol 2007; 48 (4):369-378 15. Achiam MP, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Patient acceptance of MR colonography with improved fecal tagging versus conventional colonoscopy. 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