A Technique Using EBL for Removal of Pedunculated Colon Polyps

Not Applicable

Completed

• Conditions: Colonic Polyp
• Interventions: Device: Endoscopic band ligation assisted polypectomy

• Registration Number: NCT04123080
• Lead Sponsor: Uijeongbu St. Mary Hospital

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.

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2014-01-31
• Study Completion: 2014-01-31
• Status Verified: 2019-10
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBL group	Endoscopic band ligation assisted polypectomy	Removal of large long-stalked pedunculated colonic polyps using band ligations

Primary Outcome Measures

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