SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality (SCAPURA)
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|ClinicalTrials.gov Identifier: NCT02328664|
Recruitment Status : Terminated (Interim analysis showed no added value of second look endoscopy)
First Posted : December 31, 2014
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Flexible sigmoidoscopy or colonoscopy||Not Applicable|
Rationale: colorectal polyps may harbor adenocarcinoma. Numbers are increasing due to the nationwide colorectal screening program. After endoscopic removal, rescue surgery is often performed because radicality can not be guaranteed by the pathologist. However, in 85% of surgical specimen no residual malignancy is found. Given morbidity and mortality associated with surgery a method to diagnose residual cancer is needed.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Sensitivity of Scar-biopsies for Residual Colorectal Adenocarcinoma After Endoscopic Resection With Uncertain Radicality|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Flexible sigmoidoscopy or colonoscopy
Subjects will undergo these investigation to take biopsies from the polypectomy scar.
Procedure: 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.
- Sensitivity of biopsies for residual cancer [ Time Frame: up to 1 year ]The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected specimen.
- 90-day mortality after rescue surgery [ Time Frame: 91 days from surgery ]The number of patients that died within 91 day after the operation for presumed residual adenocarcinoma.
- The sensitivity of biopsies for residual cancer in the bowel wall [ Time Frame: up to 1 year ]The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected bowel wall (regardless of regional lymph nodes)
- The number of complications (defined according to GCP) after biopsies from the polypectomy scar [ Time Frame: up to 30 days ]The number of patients with bleeding or perforation after taking biopsies from the polypectomy scar, requiring at least prolongation of treatment, or admission to hospital, or delay or speeding up of surgery.
- The sensitivity of global endoscopic assessment of polypectomy site for residual cancer at initial and follow-up endoscopy (to take scar biopsies) [ Time Frame: up to 1 year ]The number of patients in whom the endoscopic resection initially and/or at follow-up endoscopic was assessed as incomplete and who also have residual cancer in the surgically resected specimen divided by the total number of patients in whom the endoscopic resection was judged to be incomplete.
- The proportion of patients with residual cancer in the resected specimen if malignancy was unsuspected during the endoscopic polypectomy [ Time Frame: up to 1 year ]The number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy and who also have residual cancer in the surgical specimen divided by the total number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328664
|Study Director:||Frank ter Borg, MD PhD||Department of Gastroenterology & Hematology, Deventer Hospital|