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

NCT ID: NCT05849623

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2026-06-30

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).

Detailed Description

Endoscopic resection of colorectal polyps has previously been demonstrated to lower the incidence of colorectal cancer, a major cause of cancer-related mortality globally. By disrupting the progression of adenomas into carcinomas, polypectomy is essential in effectively lowering colorectal cancer mortality. There is currently a surplus of high-quality research on the best ways to remove large polyps (>20mm). For colorectal polyps of 10 to 20 mm, however, the best endoscopic resection method is unknown. Due to the lack of a standard polypectomy technique for the complete removal of medium-sized colorectal polyps, clinicians use a variety of methods according to their preferences and local resources. The historic gold standard of treatment for resecting polyps greater than 10 mm is hot endoscopic mucosal resection (EMR). The term "hot" refers to the use of electrocautery to cut through dense mucosal tissue, ablate remaining marginal dysplastic tissue, and prevent rapid bleeding through thermal vascular coagulation. However, adverse events such as perforation, prolonged bleeding, and post-polypectomy syndrome are all linked to electrocautery-induced damage. In contrast, cold snare polypectomy (CSP) and cold electrocautery minimal resection with injection (C-EMR-I) are alternative well-established techniques for the removal of polyps smaller than 10 mm, demonstrated to be associated with less delayed adverse effects than EMR. Underwater EMR (U-EMR), a novel technique developed in the last decade wherein water is instilled into the colon, allowing for submucosal fat to rise, elevating the lesion, and allowing mucosal resection in the absence of submucosal injectate. U-EMR may achieving higher en bloc resection rates, R0 resection rates, and lower recurrence rates. There are no specific recommendations for EMR of medium-sized polyps from gastroenterological and endoscopic societies globally.

The aim of this randomized control study is to compare the polyp recurrence rates and adverse events between cold snare EMR (C-EMR), hot EMR (H-EMR) and underwater EMR (U-EMR) for colorectal polyps in the size of 10-20mm.

Conditions

10-20mm Colorectal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Mucosal Resection (EMR)

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic Mucosal Resection (EMR)

Intervention Type: PROCEDURE

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

Cold Endoscopic Mucosal Resection (C-EMR)

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.

Group Type: ACTIVE_COMPARATOR

Cold Endoscopic Mucosal Resection (C-EMR)

Intervention Type: PROCEDURE

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

Underwater Endoscopic Mucosal Resection (U-EMR)

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.

Group Type: ACTIVE_COMPARATOR

Underwater Endoscopic Mucosal Resection (U-EMR)

Intervention Type: PROCEDURE

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

Interventions

Endoscopic Mucosal Resection (EMR)

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

Intervention Type: PROCEDURE

Cold Endoscopic Mucosal Resection (C-EMR)

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

Intervention Type: PROCEDURE

Underwater Endoscopic Mucosal Resection (U-EMR)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. The patient (or a legally authorized representative) provides informed consent

2. 18 years of age or older

3. Completion of the endoscopist-recommended bowel preparation

4. Presence of one eligible medium-sized polyp:

• 10-20 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.

Exclusion Criteria

1. Patient < 18 years old

2. Inability to provide informed consent

3. Inflammatory Bowel Disease,

4. Familial Polyposis

5. Pregnancy

6. Incomplete bowel preparation

7. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Samir Grover

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kareem Khalaf, HBSc, MD

Role: STUDY_DIRECTOR

Unity Health Toronto

Central Contacts

Samir Grover, MD, MEd, FRCPC

Role: CONTACT

samir.grover@unityhealth.to

416-864-5628 ext. 3967

Nikko Gimpaya, HBSc, MEd

Role: CONTACT

nikko.gimpaya@unityhealth.to

416-360-4000 ext. 77537

Other Identifiers

23-041

Identifier Type: -

Identifier Source: org_study_id