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

White River Junction Veterans Affairs Medical Center

Status: Completed

Conditions: Colon Polyps

Treatments: Procedure: Clip closure

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT01936948

CPHS-23578

Details and patient eligibility

About

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.

Full 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.

Enrollment: 928 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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928 participants in 4 patient groups

Clip closure + EndoCut

Active Comparator group

Description:

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.

Treatment:

Procedure: Clip closure

Clip closure + Coagulation

Active Comparator group

Description:

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.

Treatment:

Procedure: Clip closure

No clip closure + EndoCut

No Intervention group

Description:

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 group

Description:

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