Back to resultsThe Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
Primary Purpose
Gastric Adenoma, Early Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Polaprezinc
Rebamipide
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenoma
Eligibility Criteria
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.
Sites / Locations
- Sevrance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rebamipide group
Polaprezinc group
Arm Description
Outcomes
Primary Outcome Measures
Ulcering healing rate
Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
Secondary Outcome Measures
Scarring change rate
Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02243618
Brief Title
The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 14, 2015 (Actual)
Primary Completion Date
April 14, 2016 (Actual)
Study Completion Date
April 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenoma, Early Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebamipide group
Arm Type
Active Comparator
Arm Title
Polaprezinc group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Polaprezinc
Intervention Description
Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Intervention Description
Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
Primary Outcome Measure Information:
Title
Ulcering healing rate
Description
Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
Time Frame
4 weeks after the ESD
Secondary Outcome Measure Information:
Title
Scarring change rate
Description
Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
Time Frame
4 weeks after the ESD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sevrance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
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