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

Yonsei University153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Gastric Adenoma Early Gastric Cancer

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Ulcering healing rate

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

Time frame: 4 weeks after the ESD

Secondary Outcomes

Scarring change rate

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