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Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

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ClinicalTrials.gov Identifier: NCT03859479
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
State Scientific Centre of Coloproctology, Russian Federation

Study Description
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Brief Summary:
A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.

Condition or disease Intervention/treatment Phase
Colorectal Polyp Procedure: Cold snare polypectomy Procedure: Hot snare polypectomy Not Applicable

Detailed Description:

Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.

All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single-blinded
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cold snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital
 Procedure: Cold snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital
Active Comparator: Hot snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital
 Procedure: Hot snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital


Outcome Measures
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Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 14 days ]
  2. Complete resection rate [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Incidence of local recurrence [ Time Frame: 6 months ]
  2. The immediate bleeding or immediate perforation rate after polypectomy [ Time Frame: 1 day ]
  3. Complication rate [ Time Frame: 14 days ]
  4. Use of submucosal injection [ Time Frame: 1 day ]
  5. Polyp retrieval rate [ Time Frame: 1 day ]
  6. The procedure time [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non-pedunculated colorectal adenomas who had provided written informed consent

Exclusion Criteria:

  • known coagulopathy.
  • polyposis of the alimentary tract.
  • inflammatory bowel disease.
  • malignant polyps.
  • associated diseases in the stage of decompensation
Contacts and Locations
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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): NCT03859479


Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Contact: Stanislav Chernyshov, MD    +74991992554    stchernyshov@gmail.com   
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
More Information
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Responsible Party: State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03859479    
Other Study ID Numbers: 122
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 State Scientific Centre of Coloproctology, Russian Federation:
Cold snare polypectomy
Hot snare polypectomy
Сolorectal polyps
Endoscopic treatment
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms