NCT04123080

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

October 7, 2019

Last Update Submit

October 9, 2019

Conditions

Colonic Polyp

Keywords

Colonic PolypEndoscopic mucosal resection

Outcome Measures

Primary Outcomes (5)

  • Rate of completed polyp resection

    a lesion-free margin with both the lateral and basal tissues free of pathology

    Immediately after the intervention

  • Procedure time

    From approaching the the stalk to snare polypectomy with electrosurgical snare

    during the procedure

  • Rate of immediate postpolypectomy bleeding

    pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.

    during the procedure

  • Rate of delayed postpolypectomy bleeding

    gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery

    30 days after procedure

  • Rate of perforation

    endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.

    30 days after procedure

Study Arms (1)

EBL group

EXPERIMENTAL

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

Device: Endoscopic band ligation assisted polypectomy

Interventions

Endoscopic band ligation assisted polypectomyDEVICE

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.

EBL group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who refuse to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 20677334BACKGROUND

  • 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.

    PMID: 28212588BACKGROUND

  • 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.

    PMID: 19417747BACKGROUND

  • 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.

    PMID: 26479300BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hiun-Suk Chae, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 10, 2019

Study Start

April 1, 2012

Primary Completion

January 31, 2014

Study Completion

January 31, 2014

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share