Clinical trial NCT01936948: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
Official title: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyps
Keywords: Large colon polyps
Polyp resection
Colon cancer screening
Colonoscopy
Endoscopic mucosal resection
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Dartmouth College
name: Boston Scientific Corporation
First posted: 2013-09-06
Enrollment: 928
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

Detailed description: Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:

* A) Closing the mucosal defect after resection (Clip group) and
* B) Not closing the mucosal defect after resection (No clip group).

Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:

* A) Low power coagulation and
* B) Endocut.

Eligibility criteria: Inclusion Criteria:

* Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
* Patients with a ≥20mm non-pedunculated colon polyp

Exclusion Criteria:

* Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
* Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
* Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
* Patients with inflammatory bowel disease
* Patients who are receiving an emergency colonoscopy
* Poor general health (ASA class\>3)
* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
* Poor bowel preparation
* Pregnancy

Primary outcomes:
measure: Number of Participants With Delayed Bleeding Complications
timeFrame: 30 days following a study polyp resection
Secondary outcomes:
measure: The Overall Number of Complications
timeFrame: 30 days
measure: Complete Study Polyp Resection Rate
timeFrame: 6 months
measure: Polyp Recurrence Rate
timeFrame: 3 months to 5 years
measure: The Number of Complications Associated With Clip Use
timeFrame: 30 days
Other outcomes:
measure: Measured Factors Associated With Resection Complications
timeFrame: 30 days
measure: Measured Factors Associated With Incomplete Resection or Recurrence of Polyps
timeFrame: 5 years
Locations:
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: White River Junction VAMC, Geisel School of Medicine at Dartmouth
name: Heiko Pohl
role: STUDY_CHAIR
References:
citation: Crockett SD, Khashab M, Rex DK, Grimm IS, Moyer MT, Rastogi A, Mackenzie TA, Pohl H; Large Polyp Study Group Consortium. Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-1765.e4. doi: 10.1016/j.cgh.2021.12.036. Epub 2021 Dec 28.
citation: Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Mackenzie TA, Rex DK. Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial. Gastroenterology. 2020 Jul;159(1):119-128.e2. doi: 10.1053/j.gastro.2020.03.014. Epub 2020 Mar 12.
citation: Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.