Clinical trial NCT05273697: Clinical Study to Compare Cold Snare Underwater Polypectomy to Cold Snare Conventional Polypectomy for Colon Polyps [COLDWATER 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyps
Polypectomy
Keywords: colon polyps
underwater polypectomy
cold snare polypectomy
polypectomy
cold snare
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 396
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: percentage of muscularis mucosa included in specimen (%)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Presence or absence of submucosal in the specimen and its depth (if present)
timeFrame: through study completion, an average of 1 year
measure: Percentage of R0 Resections
timeFrame: through study completion, an average of 1 year
measure: Complication rate
timeFrame: 30 days after the polypectomy (treatment procedure)
measure: Recurrence lesion rate during repeat colonoscopy in 6-12months
timeFrame: 6-12 months after polypectomy (treatment procedure)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sismanogleio General Hospital
Study officials:
affiliation: Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece
name: Maria Zachou, MD,Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, General Hospital Laiko, Athens, Greece
name: Stylianos Kykalos, Assist.Prof
role: STUDY_DIRECTOR
affiliation: Department of Gastroenterology, University Hospital of Heraklion, University of Crete, Heraklion, Greece
name: Evangelos Kalaitzakis, Assist.Prof
role: STUDY_CHAIR
affiliation: Gastroenterology Unit, Department of Pathophysiology, School of Medicine, National and Kapodistrian University Athens, Greece
name: Stavros Sougioultzis
role: STUDY_CHAIR
References:
citation: 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.