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

Study Overview
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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.

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.

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

Conditions
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Colon Polyps

Intervention / Treatment
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* Procedure: Clip closure


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clip closure + EndoCut<br>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<br>* 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.<br>|
| Active Comparator: Clip closure + Coagulation<br>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<br>* 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.<br>|
| No Intervention: No clip closure + EndoCut<br>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<br>No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Complete Study Polyp Resection Rate | Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy | 6 months | 
| Polyp Recurrence Rate | Rate of recurrent polyp at the resection site after complete polyp resection. | 3 months to 5 years | 
| The Number of Complications Associated With Clip Use | Incidence of complications associated with application of clips. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large colon polyps, Polyp resection, Colon cancer screening, Colonoscopy, Endoscopic mucosal resection