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

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ClinicalTrials.gov Identifier: NCT05273697
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Maria Zachou, National and Kapodistrian University of Athens

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.


Condition or disease Intervention/treatment Phase
Colon Polyps Polypectomy Procedure: Underwater Cold Snare Polypectomy Procedure: Conventional Cold Snare Polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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]
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arm Intervention/treatment
Active Comparator: Underwater cold snare polypectomy group
Cold snare polypectomy after complete immersion of the polyp in the water
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

Active Comparator: Conventional cold snare polypectomy group
Cold snare polypectomy in colon lumen dilated with air
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




Primary Outcome Measures :
  1. percentage of muscularis mucosa included in specimen (%) [ Time Frame: through study completion, an average of 1 year ]
    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)


Secondary Outcome Measures :
  1. Presence or absence of submucosal in the specimen and its depth (if present) [ Time Frame: through study completion, an average of 1 year ]

    Presence or absence of submucosa

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


  2. Percentage of R0 Resections [ Time Frame: through study completion, an average of 1 year ]

    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


  3. Complication rate [ Time Frame: 30 days after the polypectomy (treatment procedure) ]
    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

  4. Recurrence lesion rate during repeat colonoscopy in 6-12months [ Time Frame: 6-12 months after polypectomy (treatment procedure) ]
    A subgroup of the sample size will undergo a follow up colonoscopy in 6-12 months in order to identify lesion recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273697


Contacts
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Contact: Zachou 6986734033 ext +30 zachou.maria@yahoo.com
Contact: Varytimiadis 6944785429 ext +30 cvaritimos@gmail.com

Locations
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Greece
Sismanogleio General Hospital Recruiting
Athens, Greece, 15126
Contact: Maria Zachou    6986734033    zachou.maria@yahoo.com   
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Maria Zachou, MD,Msc Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece
Study Director: Stylianos Kykalos, Assist.Prof 2nd Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, General Hospital Laiko, Athens, Greece
Study Chair: 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 Documents (Full-Text)

Documents provided by Maria Zachou, National and Kapodistrian University of Athens:
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Responsible Party: Maria Zachou, Principal Investigator, Gastroenterology Resident at Sismanogleio General Hospital, MD, MSc, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT05273697    
Other Study ID Numbers: PN61759
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available from the corresponding author on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Zachou, National and Kapodistrian University of Athens:
colon polyps
underwater polypectomy
cold snare polypectomy
polypectomy
cold snare
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps