AzTrials
AzTrials

Colon PolypsCOLDWATERNCT05273697

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

A study testing Underwater Cold Snare Polypectomy and Conventional Cold Snare Polypectomy in people with Colon Polyps and Polypectomy, run by National and Kapodistrian University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Colon Polyps, Polypectomy
What is being tested?
Underwater Cold Snare Polypectomy and Conventional Cold Snare Polypectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
1 siteGreece
Study dates
21 Mar 2022to 15 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Sismanogleio General Hospital

    Athens, 15126

Other trials in Greece

About this study

Official title: Randomized Clinical Trial to Compare Underwater Cold Snare Polypectomy (UCSP) to Conventional Cold Snare Polypectomy (CCSP) for Non Pedunculated Colon Polyps of Size 5-10mm [COLDWATER Study]

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.

Being tested
Underwater Cold Snare Polypectomy, Conventional Cold Snare Polypectomy
Keywords
colon polyps, underwater polypectomy, cold snare polypectomy, polypectomy, cold snare
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Underwater Cold Snare PolypectomyProcedure or surgery

    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 PolypectomyProcedure or surgery

    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
Study groups in NCT05273697
Study groupRoleWhat they receive
Underwater cold snare polypectomy groupActive comparatorCold snare polypectomy after complete immersion of the polyp in the water
Receives: Procedure: Underwater Cold Snare Polypectomy
Conventional cold snare polypectomy groupActive comparatorCold snare polypectomy in colon lumen dilated with air
Receives: Procedure: Conventional Cold Snare Polypectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: through study completion, an average of 1 year

Secondary outcomes (4)

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

    Presence or absence of submucosa

    • Measurement of submucosa depth in μm (when submucosa is present in the specimen)

    Measured: through study completion, an average of 1 year

  2. Percentage of R0 Resections

    Vial 1 : Determination of polypectomy margin according to Residual Tumor Classification Vial 1A : Determination of horizontal margins: presence of residual damage or not In order to determine the horizontal margins, 2-4 biopsies will be taken from the resection area (2 biopsies antidiametrically in polyps of 5-7 mm size, 4 biopsies in polyps of 8-10 mm size). One cup of forceps will be placed in the defect and the second in the macroscopically normal mucosa.

    The received tissue pieces will be placed in a new vial with formol (Vial 1A)

    A microscopically margin-negative resection will be characterized as "R0 resection" The determination of R0 Resection Rate will be done by measuring the number of R0 resections / number of all the resections regardless R classification

    Measured: through study completion, an average of 1 year

  3. Complication rate

    intraprocedural bleeding, post-procedural bleeding, perforation, abdominal pain not due to perforation. These complications will be evaluated by a study physician of the Gastroenterology Department with a phone call and clinical examination if needed

    Measured: 30 days after the polypectomy (treatment procedure)

  4. Recurrence lesion rate during repeat colonoscopy in 6-12months

    A subgroup of the sample size will undergo a follow up colonoscopy in 6-12 months in order to identify lesion recurrence

    Measured: 6-12 months after polypectomy (treatment procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start21 Mar 2022
  3. Primary completion11 Jun 2023
  4. Study completion15 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273697
Sponsor's protocol ID
PN61759
Acronym
COLDWATER
Status last verified
Nov 2023
First submitted
9 Feb 2022
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Available from the corresponding author on reasonable request.

Publications

  • 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.

    PubMed 36399201

Questions about this trial

What is this clinical trial studying?

A study testing Underwater Cold Snare Polypectomy and Conventional Cold Snare Polypectomy in people with Colon Polyps and Polypectomy, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of muscularis mucosa included in specimen (%) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in