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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

928 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Clip closure

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Clip closure

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No