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

NCT01936948 | Completed Results DMC

• 1 other identifier: CPHS-23578
• Study Type: interventional
• Target: 928
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyps

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Delayed Bleeding Complications

  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.

  30 days following a study polyp resection

Secondary Outcomes (4)

• The Overall Number of Complications

  30 days

• Complete Study Polyp Resection Rate

  6 months

• Polyp Recurrence Rate

  3 months to 5 years

• The Number of Complications Associated With Clip Use

  30 days

Other Outcomes (2)

• Measured Factors Associated With Resection Complications

  30 days

• Measured Factors Associated With Incomplete Resection or Recurrence of Polyps

  5 years

Study Arms (4)

Clip closure + EndoCut

ACTIVE COMPARATOR

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

Clip closure + Coagulation

ACTIVE COMPARATOR

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

No clip closure + EndoCut

NO INTERVENTION

No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.

No clip closure + Coagulation

NO INTERVENTION

No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.

Interventions

Clip closure PROCEDURE

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.

Clip closure + Coagulation; Clip closure + EndoCut

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a ≥20mm non-pedunculated colon polyp

You may not qualify if:

• 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

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• Dartmouth College: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

Related Publications (3)

• 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.

  PMID: 34971811 DERIVED

• 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.

  PMID: 32173478 DERIVED

• 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.

  PMID: 30885778 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Complete defect closure not possible in 13% of patients. Crossover to clip group in 10% of patients.

Results Point of Contact

• Title: Heiko Pohl
• Organization: White River Junction VA Medical Center

heiko.pohl@va.gov

802-295-9363

Study Officials

• Heiko Pohl

  White River Junction VAMC, Geisel School of Medicine at Dartmouth

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: April 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: October 1, 2022
• Last Updated: July 12, 2024
• Results First Posted: June 22, 2021

Record last verified: 2024-06

Locations

US (1)