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

Summary

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.

Conditions

• Colon Polyps
• Polypectomy

Interventions

PROCEDURE

Underwater Cold Snare Polypectomy

The procedure of Underwater Cold Snare Polypectomy (UP) will be as follows: 1. Complete suction of air from the intestinal tract 2. Partial opening of the intestinal lumen by using sterile room temperature water via a water pump 3. Complete immersion of the lesion in water 4. Snaring of the lesion and a small amount of surrounding healthy tissue (1-2mm) 5. Excision The objective will be the en bloc resection of the lesion including healthy tissue (about 2mm). If the en bloc resection fails, a piecemeal will be performed on as few specimens as possible

PROCEDURE

Conventional Cold Snare Polypectomy

The procedure of Conventional Cold Snare Polypectomy (CCSP) will be as follows: 1. If the entry during the endoscopy has been made with water, the water will be aspirated, and the intestinal lumen will be re-stretched using air / CO2 2. Snaring of the lesion and a small amount of surrounding healthy tissue (1-2mm) 3. Excision The objective will be the en bloc resection of the lesion including healthy tissue (about 2mm). If the en bloc resection fails, a piecemeal will be performed on as few specimens as possible

Sponsors & Collaborators

• National and Kapodistrian University of Athens

  lead OTHER

Principal Investigators

• Maria Zachou, MD,Msc · Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece

• Stylianos Kykalos, Assist.Prof · 2nd Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, General Hospital Laiko, Athens, Greece

• Evangelos Kalaitzakis, Assist.Prof · Department of Gastroenterology, University Hospital of Heraklion, University of Crete, Heraklion, Greece

• Stavros Sougioultzis · Gastroenterology Unit, Department of Pathophysiology, School of Medicine, National and Kapodistrian University Athens, Greece

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-21

Primary Completion

2023-06-11

Completion

2023-07-15

Countries

• Greece

Study Locations