Clinical trial · Interventional
The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Adenoma | Gastric Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polaprezinc | Drug | — | UNRESOLVED |
| Rebamipide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Rebamipide group
- interventionNames
- Drug: Rebamipide
- type
- ACTIVE_COMPARATOR
- label
- Polaprezinc group
- interventionNames
- Drug: Polaprezinc
Primary outcomes (1)
- measure
- Ulcering healing rate
- timeFrame
- 4 weeks after the ESD
- description
- Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available