search
Back to results

Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

Primary Purpose

Colorectal Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Cold snare polypectomy
Hot snare polypectomy
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Polyp focused on measuring Cold snare polypectomy, Hot snare polypectomy, Сolorectal polyps, Endoscopic treatment

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Scientific Centre of ColoproctologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold snare polypectomy

Hot snare polypectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

R0 resection rate
Complete resection rate

Secondary Outcome Measures

Incidence of local recurrence
The immediate bleeding or immediate perforation rate after polypectomy
Complication rate
Use of submucosal injection
Polyp retrieval rate
The procedure time

Full Information

First Posted
February 28, 2019
Last Updated
March 4, 2019
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
search

1. Study Identification

Unique Protocol Identification Number
NCT03859479
Brief Title
Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas
Official Title
A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp
Keywords
Cold snare polypectomy, Hot snare polypectomy, Сolorectal polyps, Endoscopic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blinded
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold snare polypectomy
Arm Type
Experimental
Arm Description
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
Arm Title
Hot snare polypectomy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Cold snare polypectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Hot snare polypectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
R0 resection rate
Time Frame
14 days
Title
Complete resection rate
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Incidence of local recurrence
Time Frame
6 months
Title
The immediate bleeding or immediate perforation rate after polypectomy
Time Frame
1 day
Title
Complication rate
Time Frame
14 days
Title
Use of submucosal injection
Time Frame
1 day
Title
Polyp retrieval rate
Time Frame
1 day
Title
The procedure time
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislav Chernyshov, MD
Phone
+74991992554
Email
stchernyshov@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

We'll reach out to this number within 24 hrs