search
Back to results

A Technique Using EBL for Removal of Pedunculated Colon Polyps

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic band ligation assisted polypectomy
Sponsored by
Uijeongbu St. Mary Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic Polyp, Endoscopic mucosal resection

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Polyps with head >10 mm and stalk length >10 mm;
  • Location at the distal segments of the colon; and
  • Benign features under endoscopic inspection (absence of ulceration and induration or friability).

Exclusion Criteria:

  • Patients who refuse to sign the consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    EBL group

    Arm Description

    Removal of large long-stalked pedunculated colonic polyps using band ligations

    Outcomes

    Primary Outcome Measures

    Rate of completed polyp resection
    a lesion-free margin with both the lateral and basal tissues free of pathology
    Procedure time
    From approaching the the stalk to snare polypectomy with electrosurgical snare
    Rate of immediate postpolypectomy bleeding
    pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.
    Rate of delayed postpolypectomy bleeding
    gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery
    Rate of perforation
    endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 7, 2019
    Last Updated
    October 9, 2019
    Sponsor
    Uijeongbu St. Mary Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04123080
    Brief Title
    A Technique Using EBL for Removal of Pedunculated Colon Polyps
    Official Title
    A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2012 (Actual)
    Primary Completion Date
    January 31, 2014 (Actual)
    Study Completion Date
    January 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uijeongbu St. Mary Hospital

    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
    Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. To prevent post-polypectomy bleeding effectively, the investigators developed and attempted a new endoscopic technique for removal of large long-stalked pedunculated colonic polyps using band ligations. This study aims to evaluate the safety and efficacy of a novel technique using endoscopic band ligation for removal of long-stalked pedunculated colon polyps.
    Detailed Description
    A prospective single-center study was conducted. Targeted polyps were large (head size >10 mm) with long stalk length (>10 mm) in the distal colon. After finding target lesions by standard colonoscopy, conventional upper endoscopy with rubber band (endoscopic band ligation, EBL) was applied to squeeze the mid-portion of the stalk to form an omega shape, which had the dual effect of ligation and compression of feeding blood vessels. After strangulation of the stalk, snare polypectomy was performed at the stalk site just above the ligation. The investigators evaluated several parameters, including completeness of resection, procedure time, and complications, including immediate postpolypectomy bleeding, delayed postpolypectomy bleeding, and perforation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Polyp
    Keywords
    Colonic Polyp, Endoscopic mucosal resection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EBL group
    Arm Type
    Experimental
    Arm Description
    Removal of large long-stalked pedunculated colonic polyps using band ligations
    Intervention Type
    Device
    Intervention Name(s)
    Endoscopic band ligation assisted polypectomy
    Intervention Description
    A conventional upper endoscope loaded with a band ligator was inserted in the colon and was advanced to the site of the pedunculated polyp. After approaching the lateral side of the stalk and grasping the mid-portion of the stalk using a tripod grasper. Then, the rubber band was released from the cap to ligate the stalk. Thereafter, we performed polypectomy of the remaining stalk just above the ligation by extending the electrosurgical snare.
    Primary Outcome Measure Information:
    Title
    Rate of completed polyp resection
    Description
    a lesion-free margin with both the lateral and basal tissues free of pathology
    Time Frame
    Immediately after the intervention
    Title
    Procedure time
    Description
    From approaching the the stalk to snare polypectomy with electrosurgical snare
    Time Frame
    during the procedure
    Title
    Rate of immediate postpolypectomy bleeding
    Description
    pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.
    Time Frame
    during the procedure
    Title
    Rate of delayed postpolypectomy bleeding
    Description
    gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery
    Time Frame
    30 days after procedure
    Title
    Rate of perforation
    Description
    endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.
    Time Frame
    30 days after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Polyps with head >10 mm and stalk length >10 mm; Location at the distal segments of the colon; and Benign features under endoscopic inspection (absence of ulceration and induration or friability). Exclusion Criteria: Patients who refuse to sign the consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hiun-Suk Chae, Professor
    Organizational Affiliation
    Uijeongbu St. Mary's Hospital, The Catholic University of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20677334
    Citation
    Fyock CJ, Draganov PV. Colonoscopic polypectomy and associated techniques. World J Gastroenterol. 2010 Aug 7;16(29):3630-7. doi: 10.3748/wjg.v16.i29.3630.
    Results Reference
    background
    PubMed Identifier
    28212588
    Citation
    Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
    Results Reference
    background
    PubMed Identifier
    19417747
    Citation
    Baron TH, Wong Kee Song LM. Endoscopic variceal band ligation. Am J Gastroenterol. 2009 May;104(5):1083-5. doi: 10.1038/ajg.2008.17. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26479300
    Citation
    Carmo J, Marques S, Chapim I, Barreiro P, Bispo M, Chagas C. Elastic band ligation for the removal of a colonic tubular adenoma in a diverticulum. Endoscopy. 2015;47 Suppl 1 UCTN:E490-1. doi: 10.1055/s-0034-1393142. Epub 2015 Oct 19. No abstract available.
    Results Reference
    background

    Learn more about this trial

    A Technique Using EBL for Removal of Pedunculated Colon Polyps

    We'll reach out to this number within 24 hrs