Clinical Study to Compare Cold Snare Underwater Polypectomy to Cold Snare Conventional Polypectomy for Colon Polyps [COLDWATER Study]

National and Kapodistrian University of Athens

Status: Completed

Conditions: Colon Polyps; Polypectomy

Treatments: Procedure: Underwater Cold Snare Polypectomy; Procedure: Conventional Cold Snare Polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05273697

PN61759

Details and patient eligibility

About

Colon cancer is internationally the third cause of deaths from a malignant disease. Screening colonoscopy in adults >45 years of age aims at the early diagnosis and treatment colon polyps that are precancerous lesions. Endoscopic polyp removal (polypectomy) can be done with various techniques depending on the size, morphology, location of the polyp etc. According to updated guidelines, non-pedunculated polyps of small size are treated with a cold snare in air dilated intestinal lumen (conventional cold snare polypectomy - CCSP).In recent years, several studies have described the benefits of water aided colonoscopy, as well as safety and efficacy of underwater polypectomy in large colon polyps. However, there is not enough data on small polyps which are the most commonly diagnosed.This is a prospective randomized double-blind clinical trial to compare the safety and efficacy of CCSP to underwater cold snare polypectomy (UCSP)for non-pedunculated polyps of size of 5-10 mm. A total of 398 polyps will be randomized and randomization will be performed via random numbers method of Microsoft Excel 2016. Primary outcome of this study is to determine muscularis mucosa resection rate. Secondary outcomes are the depth and percentage of R0 excisions and possible complications.

The investigators expect UCSP to ensure a higher muscularis mucosa resection rate and they attempt to examine the resection depth in the submucosal layer.These results will provide useful data for the development of guidelines in polypectomy techniques for non-pedunculated polyps 5-10mm.

Enrollment: 396 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 20years
2. Non pedunculated polyps (Paris classification Isp, Is, IIa, IIb)
3. Polyp size: diameter of 5 to 10mm
4. Endoscopic diagnosis of mucosal lesions - must not present malignant submucosal infiltration evidence like deepening, ulceration / ulcer, abnormal vessels, irregular surface, (NICE 1, NICE 2A, BASIC)
5. Informed consent
6. Patients who receive antiplatelet / anticoagulant therapy are included in the study only if their therapy has been modified according to ESGE guidelines

Exclusion criteria

1. Age <20 years old
2. Pedunculated polyps
3. Lesions with macroscopic elements of high-grade dysplasia or submucosal infiltration
4. Sites with previous polypectomy
5. Patients with idiopathic inflammatory bowel disease
6. Patients with coagulation disorders
7. Patients with severe organ failure

7.Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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396 participants in 2 patient groups

Underwater cold snare polypectomy group

Active Comparator group

Description:

Cold snare polypectomy after complete immersion of the polyp in the water

Treatment:

Procedure: Underwater Cold Snare Polypectomy

Conventional cold snare polypectomy group

Active Comparator group

Description:

Cold snare polypectomy in colon lumen dilated with air

Treatment:

Procedure: Conventional Cold Snare Polypectomy