A Technique Using EBL for Removal of Pedunculated Colon Polyps

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps

Conditions
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Colonic Polyp

Intervention / Treatment
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* Device: Endoscopic band ligation assisted polypectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBL group<br>Removal of large long-stalked pedunculated colonic polyps using band ligations | Device: Endoscopic band ligation assisted polypectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of completed polyp resection | a lesion-free margin with both the lateral and basal tissues free of pathology | Immediately after the intervention | 
| Procedure time | From approaching the the stalk to snare polypectomy with electrosurgical snare | during the procedure | 
| Rate of immediate postpolypectomy bleeding | pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention. | during the procedure | 
| Rate of delayed postpolypectomy bleeding | gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery | 30 days after procedure | 
| Rate of perforation | endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT. | 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Polyp, Endoscopic mucosal resection