drugset / Trial / NCT02243618

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

NCT02243618

Completed 153 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-01-14
Primary completion
2016-04-14
Completion
2016-04-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Polaprezinc Unknown 75 mg
Comparator Rebamipide Small molecule 100 mg
Comparator Pantoprazole Other / unclassified 40 mg