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

Not Applicable

Completed

• Conditions: Gastric Adenoma; Early Gastric Cancer
• Interventions: Drug: Rebamipide; Drug: Polaprezinc

• Registration Number: NCT02243618
• Lead Sponsor: Yonsei University

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-18
• Study Start: 2015-01-14
• Primary Completion: 2016-04-14
• Study Completion: 2016-04-14
• Status Verified: 2016-12
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. Age, between 19 and 79
2. Patients with gastric adenoma or early gastric cancer
3. Patients with ECOG-PS 0 or 1
4. Patients with adequate renal function
5. Patients with adequate hepatic function
6. Patients with adequate bone marrow function

Exclusion Criteria

1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD.
2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.
3. Patients who has undergone gastrostomy
4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide.
5. Pregnant or breast feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rebamipide group	Rebamipide	-
Polaprezinc group	Polaprezinc	-

Primary Outcome Measures

Name	Time	Method
Ulcering healing rate	4 weeks after the ESD	Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).

Secondary Outcome Measures

Name	Time	Method
Scarring change rate	4 weeks after the ESD	Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).

Trial Locations

Locations (1)

Sevrance hospital; 🇰🇷 Seoul, Korea, Republic of