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

NCT05273697 | Completed DMC

• 1 other identifier: PN61759
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colon polyps; underwater polypectomy; cold snare polypectomy; polypectomy; cold snare

Outcome Measures

Primary Outcomes (1)

• percentage of muscularis mucosa included in specimen (%)

  Determination of percentage of muscularis mucosa included in specimen. The determination of the percentage of the area containing muscularis mucosa layer will be done by measuring the length of muscularis mucosa mm / length of specimen mm x100%. Using an ocular and stage micrometer, the length of the muscularis mucosa underlining a neoplastic lesion was measured, along with the specimen's maximum diameter (mm)

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Presence or absence of submucosal in the specimen and its depth (if present)

  through study completion, an average of 1 year

• Percentage of R0 Resections

  through study completion, an average of 1 year

• Complication rate

  30 days after the polypectomy (treatment procedure)

• Recurrence lesion rate during repeat colonoscopy in 6-12months

  6-12 months after polypectomy (treatment procedure)

Study Arms (2)

Underwater cold snare polypectomy group

ACTIVE COMPARATOR

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

Procedure: Underwater Cold Snare Polypectomy

Conventional cold snare polypectomy group

ACTIVE COMPARATOR

Cold snare polypectomy in colon lumen dilated with air

Procedure: Conventional Cold Snare Polypectomy

Interventions

Underwater Cold Snare Polypectomy PROCEDURE

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

Underwater cold snare polypectomy group

Conventional Cold Snare Polypectomy PROCEDURE

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

Conventional cold snare polypectomy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 20years
• Non pedunculated polyps (Paris classification Isp, Is, IIa, IIb)
• Polyp size: diameter of 5 to 10mm
• 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)
• Informed consent
• Patients who receive antiplatelet / anticoagulant therapy are included in the study only if their therapy has been modified according to ESGE guidelines

You may not qualify if:

• Age \<20 years old
• Pedunculated polyps
• Lesions with macroscopic elements of high-grade dysplasia or submucosal infiltration
• Sites with previous polypectomy
• Patients with idiopathic inflammatory bowel disease
• Patients with coagulation disorders
• Patients with severe organ failure
• Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Sismanogleio General Hospital

Athens, 15126, Greece

Location

Related Publications (1)

• Zachou M, Varytimiadis K, Androutsakos T, Katsaras G, Zoumpouli C, Lalla E, Nifora M, Karantanos P, Nikiteas N, Sougioultzis S, Kalaitzakis E, Kykalos S. Protocol design for randomized clinical trial to compare underwater cold snare polypectomy to conventional cold snare polypectomy for non-pedunculated colon polyps of size 5-10 mm (COLDWATER study). Tech Coloproctol. 2023 Apr;27(4):325-333. doi: 10.1007/s10151-022-02731-9. Epub 2022 Nov 18.

  PMID: 36399201 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Zachou, MD,Msc

  Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece

  PRINCIPAL INVESTIGATOR

• Stylianos Kykalos, Assist.Prof

  2nd Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, General Hospital Laiko, Athens, Greece

  STUDY DIRECTOR

• Evangelos Kalaitzakis, Assist.Prof

  Department of Gastroenterology, University Hospital of Heraklion, University of Crete, Heraklion, Greece

  STUDY CHAIR

• Stavros Sougioultzis

  Gastroenterology Unit, Department of Pathophysiology, School of Medicine, National and Kapodistrian University Athens, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Gastroenterology Resident at Sismanogleio General Hospital, MD, MSc

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 10, 2022
• Study Start: March 21, 2022
• Primary Completion: June 11, 2023
• Study Completion: July 15, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)