A Technique Using EBL for Removal of Pedunculated Colon Polyps

Overview

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.

Full Title of Study: “A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2014

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.

Interventions

  • Device: Endoscopic band ligation assisted polypectomy
    • 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.

Arms, Groups and Cohorts

  • Experimental: EBL group
    • Removal of large long-stalked pedunculated colonic polyps using band ligations

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Uijeongbu St. Mary Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hiun Suk Chae, Professor – Uijeongbu St. Mary Hospital
  • Overall Official(s)
    • Hiun-Suk Chae, Professor, Principal Investigator, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea,

References

Fyock CJ, Draganov PV. Colonoscopic polypectomy and associated techniques. World J Gastroenterol. 2010 Aug 7;16(29):3630-7.

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.

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. Review.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.