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Complete resection rate of polyps: long follow-up study


- candidate number21677
- NTR NumberNTR5059
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2015
- Secondary IDsNL46939.018.14  
- Public TitleComplete resection rate of polyps: long follow-up study
- Scientific TitleComplete resection rate of polyps: long follow-up study
- ACRONYMCLEAR study: CompLEte polyp removAl Rate
- hypothesisIn recent years several studies have been published about colorectal interval carcinomas, carcinomas that develop in patients who are under colonoscopic surveillance. One of the reported explanations for interval carcinomas is incomplete removal of premalignant polyps. These could result in cancers arising at the site of previous polypectomy. Carcinomas arising from incompletely resected polyps could highlight the deficiencies in technique and inadequate assessment of resection margins. We aim to study the rate of incomplete polypectomies.
- Healt Condition(s) or Problem(s) studiedAdenomas, Polyps, Colorectal cancer, Coloscopy, Interval colorectal cancer
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Participants in a fourth round of a colorectal cancer screening pilot with a positive FIT- result (exceeding 10 μgHb/g feces ) who signed informed consent OR
*Participants of the national CRC screening programme with a positive FIT-result who signed informed consent OR
* Patients between 50-75 years old referred for diagnostic colonoscopy without coagulopathy AND
* Participants who have at least 1 colonic polyp (1-20 mm) at colonoscopy
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
* Patients who did not sign informed consent
* Patients with a known coagulopathy
* Pedunculated polyps
* Polyps that require piecemeal resection
* Patients with only polyps >20 mm
* Patients with (suspected) colorectal cancer
* Patients with suspicion of polyposis syndrome
* Patients with inflammatory bowel disease
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2015
- planned closingdate
- Target number of participants444
- InterventionsDaily care: All included patients will undergo a colonoscopy. During colonoscopy all polyps will be removed, but per segment only one polyp will be included in the study: the most proximal polyp. Surveillance will be performed at intervals based on the Dutch gastroenterology guidelines (3 or 5 years).
Study purpose: For the most proximal polyp detected, a single tattoo will be placed contralateral to the polypectomy site. During surveillance, location of previous polypectomy will be detected with help of the tattoo. If a residual polyp is detected at this polypectomy-site, this will be treated and tissue sent for histopathology. If no residual tissue is detected, several biopsies will be taken at the polypectomy site and sent for histopathology. Histopathologic evaluation of the residual tissue will be compared with histopathology of the original polyp.
- Primary outcomePercentage of incompletely resected polyps with a diameter of 1-4 mm, 5-9 and 10-20 mm (incomplete resection rate = IRR)
- Secondary outcome* Association between histopathology and IRR
* Association between method of polypectomy and IRR
* Association between polyp morphology according to the Paris classification and IRR
* Association between polyp location in the colon (proximal vs. distal and per segment) and IRR
* Association between endoscopist and IRR
- Timepointsstart inclusion april 2015
start with collecting follow-up data april 2018
- Trial web sitenot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. E. Dekker
- CONTACT for SCIENTIFIC QUERIESProf. dr. E. Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIn recent years several studies have been published about colorectal interval carcinomas, carcinomas that develop in patients who are under colonoscopic surveillance. One of the reported explanations for interval carcinomas is incomplete removal of premalignant polyps. These could result in cancers arising at the site of previous polypectomy. Carcinomas arising from incompletely resected polyps could highlight the deficiencies in technique and inadequate assessment of resection margins. We aim to study the rate of incomplete polypectomies for polyps sized 1-4 mm, 5-9 or 10-20 mm in a screening population with positive FIT (fecal immunochemical test), 50-75 years old in Amsterdam area and patients aged 50-75 years, referred for diagnostic colonoscopy.
- Main changes (audit trail)
- RECORD11-feb-2015 - 19-apr-2015


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