Optimal Resection Technique for Medium-sized (10-20mm) Colorectal Polyps

NCT05849623 | Not Yet Recruiting

• 1 other identifier: 23-041
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate which resection technique (Endoscopic Mucosal Resection (EMR), cold EMR, or underwater EMR) leads to lower recurrence rates and less adverse events in patients with colorectal polyps (10-20mm).

Conditions

10-20mm Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• Polyp Recurrence Rate

  The primary outcome of this study is the polyp recurrence rate at follow-up between the three techniques. Recurrence is evaluated 6 to 12 months after initial colonoscopy with endoscopic evaluation and biopsy of the scar. If adenoma is suspected under high-definition white light and/or electronic/conventional chromoendoscopy, the operator will remove it by snare or bioptic forceps. Final histology will be used to define recurrence rate.

  Polyp recurrence rate will be determined during the follow-up procedure performed 6-12 months after the initial colonoscopy.

Secondary Outcomes (2)

• Adverse Events

  AEs will be evaluated in both the initial and follow-up procedures. The follow-up procedure will be performed 6-12 months after the initial colonoscopy. Relevant AEs that occur during the procedure and within one day post-procedure will be recorded.

• Procedural time

  Completion times will be recorded at the time of procedure for both initial and follow-up colonoscopies (performed 6-12 months after the initial procedure). The time to complete the resection technique will be recorded during the first colonoscopy.

Study Arms (3)

Endoscopic Mucosal Resection (EMR)

ACTIVE COMPARATOR

Patients will have an electrosurgical grounding pad attached, and an Erbe VIO electrosurgical unit will be adjusted to the endoscopist's preferred EndoCut Q and Coagulation settings. The polyp will be injected submucosally with a saline and methylene blue solution, with or without epinephrine at endoscopist's discretion. Using a 15mm snare connected to the electrosurgical unit, the resection will be performed, with the initial cut including a margin of normal mucosa and subsequent cuts to ensure no residual polyp tissue remains. In case of intraprocedural bleeding, snare tip soft coagulation (STSC) or coagulation forceps may be used. The resection site will be examined and any remaining polypoid tissue will be resected. Endoclips may be used to close the defect if there is significant intraprocedural bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet.

Procedure: Endoscopic Mucosal Resection (EMR)

Cold Endoscopic Mucosal Resection (C-EMR)

ACTIVE COMPARATOR

The polyp will be positioned at the 6 o'clock position and injected submucosally with saline and methylene blue, with or without epinephrine. The size of the ensnared polyp will be limited to 10-15mm to make sure that the snare will cut through the tissue. If the snare encounters difficulty in cutting through, it will be loosened to release deeper tissue before being closed again. The base and margins of the resected polyp will be inspected for residual polyp, which will be resected using the same technique if found. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet.

Procedure: Cold Endoscopic Mucosal Resection (C-EMR)

Underwater Endoscopic Mucosal Resection (U-EMR)

ACTIVE COMPARATOR

In the Underwater EMR arm, the patient will be connected to an electrosurgical grounding pad, and an Erbe VIO electrosurgical unit with EndoCut Q and Coagulation settings will be adjusted to the endoscopist's preference. Water, instead of carbon dioxide, will be used to fill the colon. Submucosal injection will not be performed.The patient will be positioned for optimal polyp exposure, and a 15mm snare will be used. The snare will be opened and positioned with a margin of normal mucosa and used to cut the polyp, en bloc if possible. Piecemeal resection should ensure no residual polyp tissue remains. Snare tip soft coagulation or coagulation forceps may be used for intraprocedural bleeding. The base and margins of the resected polyp will be inspected for residual polyp and resected if necessary. Closure of the defect with endoclips may be considered if there is significant bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet.

Procedure: Underwater Endoscopic Mucosal Resection (U-EMR)

Interventions

Endoscopic Mucosal Resection (EMR) PROCEDURE

EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.

Endoscopic Mucosal Resection (EMR)

Cold Endoscopic Mucosal Resection (C-EMR) PROCEDURE

C-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.

Cold Endoscopic Mucosal Resection (C-EMR)

Underwater Endoscopic Mucosal Resection (U-EMR) PROCEDURE

U-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.

Underwater Endoscopic Mucosal Resection (U-EMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient (or a legally authorized representative) provides informed consent
• years of age or older
• Completion of the endoscopist-recommended bowel preparation
• Presence of one eligible medium-sized polyp:
• mm in size
• Paris classification of 0-IIa (flat, elevated lesion) on standard white light colonoscopy
• JNET Type 1 or 2A on magnifying Narrow Band Imaging (NBI) suspecting a sessile serrated lesion, adenoma, or adenoma with low-grade dysplasia.

You may not qualify if:

• Patient \< 18 years old
• Inability to provide informed consent
• Inflammatory Bowel Disease,
• Familial Polyposis
• Pregnancy
• Incomplete bowel preparation
• Patients with ineligible lesion:
• Paris classification of 0-Ip or 0-Is on standard white light colonoscopy,
• JNET Type 1 suspecting a hyperplastic polyp, or Type 2B or 3 suspecting a high- grade dysplasia or adenocarcinoma.

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Kareem Khalaf, HBSc, MD

  Unity Health Toronto

  STUDY DIRECTOR

Central Study Contacts

Samir Grover, MD, MEd, FRCPC

CONTACT

416-864-5628; samir.grover@unityhealth.to

Nikko Gimpaya, HBSc, MEd

CONTACT

416-360-4000; nikko.gimpaya@unityhealth.to

Study Design

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

Model Details: Participants will be randomly assigned to one of three study arms.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 9, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share