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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02243618

Enrollment

153

Registered

2014-09-18

Start date

2015-01-14

Completion date

2016-04-14

Last updated

2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Gastric Cancer, Gastric Adenoma

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.

Interventions

DRUGPolaprezinc

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

DRUGRebamipide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 79 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026