The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
Conditions
Gastric Adenoma and Early Gastric Cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Polaprezinc Type: Drug
Name: Rebamipide Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 19 Years
Gender: Both
Criteria: 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.
Location
Sevrance hospital
Seoul, Korea, Republic of
Status: Recruiting
Start Date
September 2014
Completion Date
August 2015
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page