NCT05273697: COLDWATER

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

Completed NA Last updated 24 November 2023

What this trial tests

NA trial testing Underwater Cold Snare Polypectomy in Colon Polyps in 396 participants. Completed in 15 July 2023.

Timeline

21 March 2022

Primary endpoint
11 June 2023

15 July 2023

Quick facts

Lead sponsor	National and Kapodistrian University of Athens
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	396
Start date	21 March 2022
Primary completion	11 June 2023
Estimated completion	15 July 2023
Sites	1 location across Greece

Drugs / interventions tested

• Underwater Cold Snare Polypectomy
• Conventional Cold Snare Polypectomy

Conditions studied

• Colon Polyps — all drugs for Colon Polyps →
• Polypectomy — all drugs for Polypectomy →

Sponsor

National and Kapodistrian University of Athens

Who can join

20 and older, any sex, with Colon Polyps or Polypectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Zachou M, Varytimiadis K, Androutsakos T, Katsaras G, et al · · 2023 · cited 2× · PMID 36399201 · DOI 10.1007/s10151-022-02731-9