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

Colon Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01936948
• Other study ID #: CPHS-23578
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: White River Junction Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1257
• Est. completion date: December 2022
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Polyps
• Colonic Polyps
• Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center	Boston Scientific Corporation, Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measured Factors Associated With Resection Complications	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.	30 days
Other	Measured Factors Associated With Incomplete Resection or Recurrence of Polyps	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.	5 years
Primary	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	The Overall Number of Complications	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.	30 days
Secondary	Complete Study Polyp Resection Rate	Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy	6 months
Secondary	Polyp Recurrence Rate	Rate of recurrent polyp at the resection site after complete polyp resection.	3 months to 5 years
Secondary	The Number of Complications Associated With Clip Use	Incidence of complications associated with application of clips.	30 days