Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm (COLDSNAP-1)
Primary Purpose
Colorectal Polyp, Colorectal Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Polyp focused on measuring coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps
Eligibility Criteria
Inclusion Criteria:
- indication for colonoscopy
- signed informed consent
- at least one polyp of the size 10-15mm
- American Society of Anesthesiologists-classification (ASA) I-III
Exclusion Criteria:
- American Society of Anesthesiologists-classification (ASA) IV-VI
- Inflammatory bowel disease (IBD)
- known/suspected invasive colorectal cancer
- contraindications for polypectomy
- emergency indication for colonoscopy
Sites / Locations
- 2nd Medical Department, Klinikum rechts der Isar
Outcomes
Primary Outcome Measures
Complete Resection Rate (R0-resection)
Complete resection rate of polyps resected by cold snare polypectomy
Secondary Outcome Measures
Required additional attempts for complete resection during surgery
Where there more than one attempts for complete resection of the polyp during surgery?
Incidence of immediate and delayed bleeding.
Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Technical Impossibility of CSP during surgery
Necessity of changing to HSP, if CSP is technically not possible
Full Information
NCT ID
NCT04464837
First Posted
June 11, 2020
Last Updated
July 6, 2020
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT04464837
Brief Title
Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm
Acronym
COLDSNAP-1
Official Title
Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
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
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.
In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp, Colorectal Adenoma
Keywords
coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Proof-Of-Concept
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
Other Intervention Name(s)
Olympus SnareMaster® Plus
Intervention Description
If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare
Primary Outcome Measure Information:
Title
Complete Resection Rate (R0-resection)
Description
Complete resection rate of polyps resected by cold snare polypectomy
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Required additional attempts for complete resection during surgery
Description
Where there more than one attempts for complete resection of the polyp during surgery?
Time Frame
during surgery
Title
Incidence of immediate and delayed bleeding.
Description
Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Time Frame
3 weeks
Title
Technical Impossibility of CSP during surgery
Description
Necessity of changing to HSP, if CSP is technically not possible
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication for colonoscopy
signed informed consent
at least one polyp of the size 10-15mm
American Society of Anesthesiologists-classification (ASA) I-III
Exclusion Criteria:
American Society of Anesthesiologists-classification (ASA) IV-VI
Inflammatory bowel disease (IBD)
known/suspected invasive colorectal cancer
contraindications for polypectomy
emergency indication for colonoscopy
Facility Information:
Facility Name
2nd Medical Department, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm
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