SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality
NCT ID: NCT02328664
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
246 participants
INTERVENTIONAL
2015-08-31
2019-05-31
Brief Summary
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Detailed Description
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Biopsies from the polypectomy site are variably used to reduce the likelihood of residual tumor at the polypectomy site under these circumstances. However, the sensitivity of such biopsies is unknown.
Objective: to evaluate the sensitivity of second-look endoscopic biopsies from the polypectomy site for residual tumor.
Study design: prospective cross-sectional design using a multi-center approach. Study population: patients planned for rescue surgery for the sole reason of (potentially) irradical endoscopic resection of a colorectal adenocarcinoma without poor differentiation, lymphovascular invasion or tumor budding and without other signs of dissemination.
Intervention: endoscopic biopsies from the polypectomy site before operation. Main study parameters/endpoints: sensitivity of second-look biopsies from the polypectomy site for residual tumor in the resected bowel and postoperative mortality. Various other factors will be assessed that might be associated with residual cancer.
Nature and extent of the burden and risks associated with participation and benefit: Depending on the situation: a): In case a tattoo needs to be done of the polypectomy site, a second endoscopy is done anyway and taking biopsies (painless) will be of no extra burden; b): In case no tattoo needs to be done a sigmoidoscopy (lesion distal to the splenic flexure) or colonoscopy (proximal to the splenic flexure) needs to be arranged for the purpose of this study. A sigmoidoscopy takes 10-20 minutes. Preparation consists of two enemas. A colonoscopy takes 20-30 minutes. Preparation consists of drinking 3 litre of MoviPrep®, both usually doe at home. Notice that the patient has recent experience with colonoscopy. If necessary, both investigations can be arranged under conscious sedation (the rule in colonoscopy), which also implies day-care admission. The risk of complications of a second endoscopy is estimated \< 1:5000. The benefit of a 2nd colonoscopy is the discovery of new polyps in 10-25% of cases.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Flexible sigmoidoscopy or colonoscopy
Subjects will undergo these investigation to take biopsies from the polypectomy scar.
Flexible sigmoidoscopy or colonoscopy
Depending on the localization of the scar of the malignant polyp, either a flexible sigmoidoscopy or colonoscopy will be done to take biopsies from the polypectomy scar.
Interventions
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Flexible sigmoidoscopy or colonoscopy
Depending on the localization of the scar of the malignant polyp, either a flexible sigmoidoscopy or colonoscopy will be done to take biopsies from the polypectomy scar.
Eligibility Criteria
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Inclusion Criteria
* Endoscopically removed colorectal lesion with the following pathological characteristics:
* A moderately-to-well differentiated adenocarcinoma.
* If possible to judge: distance between adenocarcinoma and vertical or lateral resection margin is less than 1 mm.
* In case of piecemeal resection: unjudgeable radicality (mostly due to loss of orientation and multiple fragments).
* Absence of / unjudgeable lymphatic / vascular invasion.
* No or only grade I tumor budding.
* No suspicion of dissemination on the following investigations: serum carcino-embryonic antigen, a computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of a rectal tumor (less than 15 cm from the anal verge): an additional magnetic resonance imaging of the rectum.
* Operation is advised in agreement with the Dutch Guideline on Colorectal cancer, planned and agreed on by the patient.
* Written informed consent is obtained.
* Patients already receiving anti-tumor treatment for another tumor or a synchronic colorectal cancer.
* Patients in whom a second-look endoscopy would require major and unacceptable effort and / or resources, for instance clinical admission for bowel preparation, long travel, general anesthesia, extremely difficult to reach polypectomy site. Such at the decision of the patient and / or treating physician.
* Patient is planned for trans-anal surgery.
* Patient is not planned for surgery.
* Patient is pregnant.
* Patient does not provide written informed consent or is unable to provide such.
Exclusion Criteria
* A radical en-bloc resection with a free vertical and lateral margin of ≧ 1 mm.
* A poorly differentiated or signet-cell containing adenocarcinoma.
* Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal resection, no exclusion is done).
* Tumor budding grade II-III.
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
UMC Utrecht
OTHER
Dr. Frank ter Borg MD PhD
OTHER
Responsible Party
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Dr. Frank ter Borg MD PhD
MD PhD, Gastroenterologist
Principal Investigators
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Frank ter Borg, MD PhD
Role: STUDY_DIRECTOR
Department of Gastroenterology & Hematology, Deventer Hospital
Locations
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Medical Center de Veluwe
Apeldoorn, Gelderland, Netherlands
Gelre Hospitals
Apeldoorn, Gelderland, Netherlands
Hospital Gelderse Vallei
Ede, Gelderland, Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Maasstad Hospital Pantein
Beugen, North Brabant, Netherlands
Amphia Hospital
Breda, North Brabant, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Bernhoven
Uden, North Brabant, Netherlands
The Netherlands Cancer Institute Antoni van Leeuwenhoekhuis
Amsterdam, North Holland, Netherlands
Medical Center Slotervaart
Amsterdam, North Holland, Netherlands
Onze Lieve Vrouwe Gasthuis (Oost & West)
Amsterdam, North Holland, Netherlands
Academical Medical Center, Gastroenterology department
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Haarlem, North Holland, Netherlands
Deventer Hospital
Deventer, Overijssel, Netherlands
Ziekenhuis Groep Twente
Hengelo, Overijssel, Netherlands
Isala Clinics
Zwolle, Overijssel, Netherlands
Nij Smellinghe Hospital
Drachten, Provincie Friesland, Netherlands
Antonius Hospital Sneek-Emmeloord
Sneek, Provincie Friesland, Netherlands
IJsselland Hospital
Capelle aan den IJssel, South Holland, Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
Rivas Zorggroep
Gorinchem, South Holland, Netherlands
Groene Hart Hospital
Gouda, South Holland, Netherlands
Alrijne Hospital
Leiden, South Holland, Netherlands
Erasmus Medical Center, Gastroenterology department
Rotterdam, South Holland, Netherlands
Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Ikazia Hospital
Rotterdam, South Holland, Netherlands
Vlietland Hospital
Schiedam, South Holland, Netherlands
Haga Hospital
The Hague, South Holland, Netherlands
Meander Medical Center
Amersfoort, Utrecht, Netherlands
Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Martini Hospital
Groningen, , Netherlands
University Medical Center Utrecht, Gastroenterology department
Utrecht, , Netherlands
Countries
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References
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Mitchell PJ, Haboubi NY. The malignant adenoma: when to operate and when to watch. Surg Endosc. 2008 Jul;22(7):1563-9. doi: 10.1007/s00464-008-9850-y. Epub 2008 Mar 25.
Seitz U, Bohnacker S, Seewald S, Thonke F, Brand B, Braiutigam T, Soehendra N. Is endoscopic polypectomy an adequate therapy for malignant colorectal adenomas? Presentation of 114 patients and review of the literature. Dis Colon Rectum. 2004 Nov;47(11):1789-96; discussion 1796-7. doi: 10.1007/s10350-004-0680-2.
Butte JM, Tang P, Gonen M, Shia J, Schattner M, Nash GM, Temple LK, Weiser MR. Rate of residual disease after complete endoscopic resection of malignant colonic polyp. Dis Colon Rectum. 2012 Feb;55(2):122-7. doi: 10.1097/DCR.0b013e3182336c38.
Meining A, von Delius S, Eames TM, Popp B, Seib HJ, Schmitt W. Risk factors for unfavorable outcomes after endoscopic removal of submucosal invasive colorectal tumors. Clin Gastroenterol Hepatol. 2011 Jul;9(7):590-4. doi: 10.1016/j.cgh.2011.02.002. Epub 2011 Feb 12.
Benizri EI, Bereder JM, Rahili A, Bernard JL, Vanbiervliet G, Filippi J, Hebuterne X, Benchimol D. Additional colectomy after colonoscopic polypectomy for T1 colon cancer: a fine balance between oncologic benefit and operative risk. Int J Colorectal Dis. 2012 Nov;27(11):1473-8. doi: 10.1007/s00384-012-1464-0. Epub 2012 Mar 29.
Di Gregorio C, Bonetti LR, de Gaetani C, Pedroni M, Kaleci S, Ponz de Leon M. Clinical outcome of low- and high-risk malignant colorectal polyps: results of a population-based study and meta-analysis of the available literature. Intern Emerg Med. 2014 Mar;9(2):151-60. doi: 10.1007/s11739-012-0772-2. Epub 2012 Mar 27.
Kitajima K, Fujimori T, Fujii S, Takeda J, Ohkura Y, Kawamata H, Kumamoto T, Ishiguro S, Kato Y, Shimoda T, Iwashita A, Ajioka Y, Watanabe H, Watanabe T, Muto T, Nagasako K. Correlations between lymph node metastasis and depth of submucosal invasion in submucosal invasive colorectal carcinoma: a Japanese collaborative study. J Gastroenterol. 2004 Jun;39(6):534-43. doi: 10.1007/s00535-004-1339-4.
Ueno H, Mochizuki H, Hashiguchi Y, Shimazaki H, Aida S, Hase K, Matsukuma S, Kanai T, Kurihara H, Ozawa K, Yoshimura K, Bekku S. Risk factors for an adverse outcome in early invasive colorectal carcinoma. Gastroenterology. 2004 Aug;127(2):385-94. doi: 10.1053/j.gastro.2004.04.022.
Netzer P, Forster C, Biral R, Ruchti C, Neuweiler J, Stauffer E, Schonegg R, Maurer C, Husler J, Halter F, Schmassmann A. Risk factor assessment of endoscopically removed malignant colorectal polyps. Gut. 1998 Nov;43(5):669-74. doi: 10.1136/gut.43.5.669.
Cooper GS, Xu F, Barnholtz Sloan JS, Koroukian SM, Schluchter MD. Management of malignant colonic polyps: a population-based analysis of colonoscopic polypectomy versus surgery. Cancer. 2012 Feb 1;118(3):651-9. doi: 10.1002/cncr.26340. Epub 2011 Jul 12.
Ikematsu H, Yoda Y, Matsuda T, Yamaguchi Y, Hotta K, Kobayashi N, Fujii T, Oono Y, Sakamoto T, Nakajima T, Takao M, Shinohara T, Murakami Y, Fujimori T, Kaneko K, Saito Y. Long-term outcomes after resection for submucosal invasive colorectal cancers. Gastroenterology. 2013 Mar;144(3):551-9; quiz e14. doi: 10.1053/j.gastro.2012.12.003. Epub 2012 Dec 8.
Gijsbers KM, Post Z, Schrauwen RWM, Tang TJ, Bisseling TM, Bac DJ, Veenstra RP, Schreuder RM, Epping Stippel LSM, de Vos Tot Nederveen Cappel WH, Slangen RME, van Lelyveld N, Witteman EM, van Milligen de Wit MAWM, Honkoop P, Alderlieste Y, Ter Borg PJC, van Roermund R, Schmittgens S, Dekker E, Leeuwenburgh I, de Ridder RJJ, Zonneveld AM, Hadithi M, van Leerdam ME, Bruno MJ, Vleggaar FP, Moons LMG, Koch AD, Ter Borg F. Low value of second-look endoscopy for detecting residual colorectal cancer after endoscopic removal. Gastrointest Endosc. 2020 Jul;92(1):166-172. doi: 10.1016/j.gie.2020.01.056. Epub 2020 Feb 25.
Other Identifiers
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SCAPURA-Study
Identifier Type: -
Identifier Source: org_study_id