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

NCT ID: NCT02243618

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-14
• Study Completion Date: 2016-04-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebamipide group

Group Type: ACTIVE_COMPARATOR

Rebamipide

Intervention Type: DRUG

Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.

Polaprezinc group

Group Type: ACTIVE_COMPARATOR

Polaprezinc

Intervention Type: DRUG

Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.

Interventions

Polaprezinc

Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.

Intervention Type: DRUG

Rebamipide

Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sevrance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0381

Identifier Type: -

Identifier Source: org_study_id