Clinical trial · Interventional
SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality
The Sensitivity of Scar-biopsies for Residual Colorectal Adenocarcinoma After Endoscopic Resection With Uncertain Radicality
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis showed no added value of second look endoscopy
Summary
Brief summary (as posted)
After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma, pathology usually can not guarantee a radical resection from an oncological point of view. In such case, additional surgical resection is advised. However, only in 15% of patients, residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from the polypectomy scar for residual adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexible sigmoidoscopy or colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Flexible sigmoidoscopy or colonoscopy
- description
- Subjects will undergo these investigation to take biopsies from the polypectomy scar.
- interventionNames
- Procedure: Flexible sigmoidoscopy or colonoscopy
Primary outcomes (1)
- measure
- Sensitivity of biopsies for residual cancer
- timeFrame
- up to 1 year
- description
- The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected specimen.
Secondary outcomes (5)
- measure
- 90-day mortality after rescue surgery
- timeFrame
- 91 days from surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 or above. * 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. Exclusion Criteria: * Pathology shows one or more of the following characteristics: * 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. * Suspicion of dissemination on investigations as mentioned in the inclusion criteria. * 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.
References
Publications (12)
- BACKGROUNDMitchell 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. PMID 18363065
- BACKGROUNDSeitz 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. PMID 15622570
- BACKGROUNDButte 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. PMID 22228153
- BACKGROUNDMeining 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. PMID 21320641
- BACKGROUNDBenizri 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. PMID 22454048
- BACKGROUNDDi 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. PMID 22451095
- BACKGROUNDKitajima 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.