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

Study Overview
=================
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.

Conditions
-----------------
Gastric Adenoma, Early Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Polaprezinc
* Drug: Rebamipide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age, between 19 and 79 Patients with gastric adenoma or early gastric cancer Patients with ECOG-PS 0 or 1 Patients with adequate renal function Patients with adequate hepatic function Patients with adequate bone marrow function Exclusion Criteria: Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD. Patients who has undergone gastrostomy Patients with allergy for pantoprazole, polaprezinc, or rebamipide. Pregnant or breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rebamipide group<br> | Drug: Rebamipide<br>* Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.<br>|
| Active Comparator: Polaprezinc group<br> | Drug: Polaprezinc<br>* Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcering healing rate | Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide). | 4 weeks after the ESD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scarring change rate | Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide). | 4 weeks after the ESD |