Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

• ClinicalTrials.gov Identifier: NCT01936948
• Recruitment Status: Unknown
• First Posted: September 6, 2013
• Results First Posted: June 22, 2021
• Last Update Posted: June 22, 2021
• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: Dartmouth College; Boston Scientific Corporation
• Information provided by (Responsible Party): Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colon Polyps	Procedure: Clip closure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
• Actual Study Start Date: April 2013
• Actual Primary Completion Date: October 2017
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Clip closure + EndoCut; Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.	Procedure: Clip closure; Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.
Active Comparator: Clip closure + Coagulation; Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.	Procedure: Clip closure; Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.
No Intervention: No clip closure + EndoCut; No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
No Intervention: No clip closure + Coagulation; No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Delayed Bleeding Complications [ Time Frame: 30 days following a study polyp resection ]
   A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.

Secondary Outcome Measures :

1. The Overall Number of Complications [ Time Frame: 30 days ]
   Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.
2. Complete Study Polyp Resection Rate [ Time Frame: 6 months ]
   Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy
3. Polyp Recurrence Rate [ Time Frame: 3 months to 5 years ]
   Rate of recurrent polyp at the resection site after complete polyp resection.
4. The Number of Complications Associated With Clip Use [ Time Frame: 30 days ]
   Incidence of complications associated with application of clips.

Other Outcome Measures:

1. Measured Factors Associated With Resection Complications [ Time Frame: 30 days ]
   Factors that may be associated with complications, including electrocautery setting, polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection.
2. Measured Factors Associated With Incomplete Resection or Recurrence of Polyps [ Time Frame: 5 years ]
   Factors that may be associated with incomplete resection may include prior attempts of removal, use of adjunctive argon plasma coagulation for residual polyp removal, polyp size, location, histology.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Vermont

White River Junction VAMC

White River Junction, Vermont, United States, 05009

Sponsors and Collaborators

White River Junction Veterans Affairs Medical Center

Dartmouth College

Boston Scientific Corporation

Investigators

• Study Chair: Heiko Pohl; White River Junction VAMC, Geisel School of Medicine at Dartmouth

  Study Documents (Full-Text)

Documents provided by Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] September 13, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Dr. Heiko Pohl, Principal Investigator, White River Junction Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT01936948
• Other Study ID Numbers: CPHS-23578
• First Posted: September 6, 2013
• Results First Posted: June 22, 2021
• Last Update Posted: June 22, 2021
• Last Verified: May 2021

Keywords provided by Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center:

Large colon polyps; Polyp resection; Colon cancer screening; Colonoscopy; Endoscopic mucosal resection

Additional relevant MeSH terms:

Polyps; Colonic Polyps; Pathological Conditions, Anatomical; Intestinal Polyps