MedDataX Logo

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

NCT ID: NCT05273697

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Polyps Polypectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Underwater cold snare polypectomy group

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

Group Type ACTIVE_COMPARATOR

Underwater Cold Snare Polypectomy

Intervention Type 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

Conventional cold snare polypectomy group

Cold snare polypectomy in colon lumen dilated with air

Group Type ACTIVE_COMPARATOR

Conventional Cold Snare Polypectomy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Zachou

Principal Investigator, Gastroenterology Resident at Sismanogleio General Hospital, MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Zachou, MD,Msc

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece

Stylianos Kykalos, Assist.Prof

Role: STUDY_DIRECTOR

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

Evangelos Kalaitzakis, Assist.Prof

Role: STUDY_CHAIR

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

Stavros Sougioultzis

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sismanogleio General Hospital

Athens, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36399201 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PN61759

Identifier Type: -

Identifier Source: org_study_id