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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Underwater cold snare polypectomy group | Active Comparator | Cold snare polypectomy after complete immersion of the polyp in the water |
|
| Conventional cold snare polypectomy group | Active Comparator | Cold snare polypectomy in colon lumen dilated with air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Underwater Cold Snare Polypectomy | Procedure | The procedure of Underwater Cold Snare Polypectomy (UP) will be as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through study completion, an average of 1 year |
| Percentage of R0 Resections |
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Inclusion Criteria:
Exclusion Criteria:
7.Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Zachou, MD,Msc | Department of Gastroenterology, General Hospital of Athens Sismanogleio, Greece | Principal Investigator |
| Stylianos Kykalos, Assist.Prof | 2nd Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, General Hospital Laiko, Athens, Greece | Study Director |
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sismanogleio General Hospital | Athens | 15126 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36399201 | Derived | 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. |
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Available from the corresponding author on reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2021 |
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| Conventional Cold Snare Polypectomy | Procedure | The procedure of Conventional Cold Snare Polypectomy (CCSP) will be as follows:
|
|
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 |
| through study completion, an average of 1 year |
| 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 | 30 days after the polypectomy (treatment procedure) |
| 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 | 6-12 months after polypectomy (treatment procedure) |
| Feb 9, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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