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Completed

NCT Number: NCT04123080

A Technique Using EBL for Removal of Pedunculated Colon Polyps

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.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic band ligation assisted polypectomy

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.

Primary outcomes

  1. 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

  2. Procedure time

    Time frame: during the procedure

    From approaching the the stalk to snare polypectomy with electrosurgical snare

  3. 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.

  4. Rate of delayed postpolypectomy bleeding

    Time frame: 30 days after procedure

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

  5. 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.

Sponsors and collaborators

Lead sponsor

Uijeongbu St. Mary Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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