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Completed

NCT Number: NCT02243618

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

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.

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Key information

Conditions

Gastric Adenoma Digestive System Diseases Digestive System Neoplasms Early Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sevrance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polaprezinc

Drug

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

rebamipide

Drug

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

Primary outcomes

  1. Ulcering healing rate

    Time frame: 4 weeks after the ESD

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

Secondary outcomes

  1. Scarring change rate

    Time frame: 4 weeks after the ESD

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2014
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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