The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
1 other identifier
interventional
153
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedStudy Start
First participant enrolled
January 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2016
CompletedMarch 27, 2019
December 1, 2016
1.2 years
September 15, 2014
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Ulcering healing rate
Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
4 weeks after the ESD
Secondary Outcomes (1)
Scarring change rate
4 weeks after the ESD
Study Arms (2)
Rebamipide group
ACTIVE COMPARATORPolaprezinc group
ACTIVE COMPARATORInterventions
Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.
Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sevrance hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
September 18, 2014
Study Start
January 14, 2015
Primary Completion
April 14, 2016
Study Completion
April 14, 2016
Last Updated
March 27, 2019
Record last verified: 2016-12