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

Early Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243618
• Other study ID #: 4-2014-0381
• Status: Completed
• Phase: N/A
• Start date: January 14, 2015
• Est. completion date: April 14, 2016

Study information

• Verified date: December 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 14, 2016
• Est. primary completion date: April 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Early Gastric Cancer
• Gastric Adenoma
• Stomach Neoplasms

Intervention

Drug:
• Polaprezinc
Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.
• Rebamipide
Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.

Locations

Country	Name	City	State
Korea, Republic of	Sevrance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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