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A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm) (COLDSNAP-2)

Primary Purpose

Adenomatous Polyps

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Comparator: Hot Snare Polypectomy
Experimental: Cold Snare Polypectomy
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenomatous Polyps

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for colonoscopy
  • at least 1 adenomatous polyp 5-15 mm
  • provided written informed consent

Exclusion Criteria:

  • American Society of Anaesthesiologists class IV or higher
  • florid inflammatory bowel disease
  • emergency indication for colonoscopy
  • haemorrhagic diathesis
  • continued dual antiplatelet therapy
  • continued anticoagulant therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Hot Snare Polypectomy

    Cold Snare Polypectomy

    Arm Description

    If an eligible polyp 5-15 mm (as compared by the size of the snare) is found, according to the randomized group, HSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.

    If an eligible polyp 5-15 mm (as compared by the size of the snare) is found, according to the randomized group, CSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.

    Outcomes

    Primary Outcome Measures

    Complete resection rate
    The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.

    Secondary Outcome Measures

    En-bloc resection rate
    Number of additional resections (snare/forceps) needed.
    Rate of immediate bleeding with necessity of haemostasis
    Immediate bleeding: Bleeding >30 seconds after snaring.
    Rate of impossible resection by CSP
    An impossible resection by CSP needs electrocautery for successful resection.
    Time required for resection
    Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.
    Rate of procedure-related adverse events.
    Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 29, 2021
    Sponsor
    Technical University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04816292
    Brief Title
    A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm)
    Acronym
    COLDSNAP-2
    Official Title
    A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm) - A Randomized Controlled Trial (COLDSNAP-2)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 2023 (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 - 19 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 randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 5-15 mm with CSP and HSP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenomatous Polyps

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    850 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hot Snare Polypectomy
    Arm Type
    Active Comparator
    Arm Description
    If an eligible polyp 5-15 mm (as compared by the size of the snare) is found, according to the randomized group, HSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
    Arm Title
    Cold Snare Polypectomy
    Arm Type
    Experimental
    Arm Description
    If an eligible polyp 5-15 mm (as compared by the size of the snare) is found, according to the randomized group, CSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
    Intervention Type
    Procedure
    Intervention Name(s)
    Active Comparator: Hot Snare Polypectomy
    Intervention Description
    Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
    Intervention Type
    Procedure
    Intervention Name(s)
    Experimental: Cold Snare Polypectomy
    Intervention Description
    Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
    Primary Outcome Measure Information:
    Title
    Complete resection rate
    Description
    The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    En-bloc resection rate
    Description
    Number of additional resections (snare/forceps) needed.
    Time Frame
    During procedure
    Title
    Rate of immediate bleeding with necessity of haemostasis
    Description
    Immediate bleeding: Bleeding >30 seconds after snaring.
    Time Frame
    During procedure
    Title
    Rate of impossible resection by CSP
    Description
    An impossible resection by CSP needs electrocautery for successful resection.
    Time Frame
    During procedure
    Title
    Time required for resection
    Description
    Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.
    Time Frame
    During procedure
    Title
    Rate of procedure-related adverse events.
    Description
    Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.
    Time Frame
    6 months

    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 at least 1 adenomatous polyp 5-15 mm provided written informed consent Exclusion Criteria: American Society of Anaesthesiologists class IV or higher florid inflammatory bowel disease emergency indication for colonoscopy haemorrhagic diathesis continued dual antiplatelet therapy continued anticoagulant therapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christoph Schlag, MD
    Phone
    +49894140
    Ext
    4781
    Email
    christoph.schlag@mri.tum.de

    12. IPD Sharing Statement

    Learn more about this trial

    A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm)

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