A Technique Using EBL for Removal of Pedunculated Colon Polyps

NCT ID: NCT04123080

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-01

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Polyp

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EBL group

Removal of large long-stalked pedunculated colonic polyps using band ligations

Group Type EXPERIMENTAL

Endoscopic band ligation assisted polypectomy

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uijeongbu St. Mary Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hiun Suk Chae

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hiun-Suk Chae, Professor

Role: PRINCIPAL_INVESTIGATOR

Uijeongbu St. Mary's Hospital, The Catholic University of Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20677334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28212588 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 19417747 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 26479300 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UC12RISI0173

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PULSed Field ablAtion of coloRectal Polyps
NCT06317727 NOT_YET_RECRUITING