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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02243618
Other study ID # 4-2014-0381
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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