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

NCT02243618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-03-27

No results posted yet for this study

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

Interventions

DRUG

Polaprezinc

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

DRUG

Rebamipide

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-14
Primary Completion
2016-04-14
Completion
2016-04-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243618 on ClinicalTrials.gov