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
About this trial
This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic Polyp, Endoscopic mucosal resection
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
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
NCT ID
NCT04123080
First Posted
October 7, 2019
Last Updated
October 9, 2019
Sponsor
Uijeongbu St. Mary Hospital
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
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A Technique Using EBL for Removal of Pedunculated Colon Polyps
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