Clinical Trial: The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief Summary: Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.

Detailed Summary:
Sponsor: Yonsei University

Current Primary Outcome: Ulcering healing rate [ Time Frame: 4 weeks after the ESD ]

Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).


Original Primary Outcome: Same as current

Current Secondary Outcome: Scarring change rate [ Time Frame: 4 weeks after the ESD ]

Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: September 15, 2014
Date Started: September 2014
Date Completion: August 2015
Last Updated: September 15, 2014
Last Verified: July 2014