A Technique Using EBL for Removal of Pedunculated Colon Polyps

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123080
• Other study ID #: UC12RISI0173
• Status: Completed
• Phase: N/A
• Start date: April 1, 2012
• Est. completion date: January 31, 2014

Study information

• Verified date: October 2019
• Source: Uijeongbu St. Mary Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uijeongbu St. Mary Hospital

References & Publications (4)

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. — View 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. — View 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. — View Citation

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

Outcome

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