Clinical trial NCT04123080: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Keywords: Colonic Polyp
Endoscopic mucosal resection
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of completed polyp resection
timeFrame: Immediately after the intervention
measure: Procedure time
timeFrame: during the procedure
measure: Rate of immediate postpolypectomy bleeding
timeFrame: during the procedure
measure: Rate of delayed postpolypectomy bleeding
timeFrame: 30 days after procedure
measure: Rate of perforation
timeFrame: 30 days after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uijeongbu St. Mary's Hospital, The Catholic University of Korea
name: Hiun-Suk Chae, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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