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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02243618
• Collaborator: (none)
• Enrollment: 153
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 10.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Adenoma; Early Gastric Cancer	Drug: Polaprezinc; Drug: Rebamipide	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Jan 14, 2015
• Actual Primary Completion Date: Apr 14, 2016
• Actual Study Completion Date: Apr 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rebamipide group	Drug: Rebamipide; Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
Active Comparator: Polaprezinc group	Drug: Polaprezinc; Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sevrance hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02243618
• Other Study ID Numbers: 4-2014-0381
• First Posted: Sep 18, 2014
• Last Update Posted: Mar 27, 2019
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Adenoma; Rebamipide; Polaprezinc

Study Results

No Results Posted as of Mar 27, 2019