The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Study Overview
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Brief Summary
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This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.

Official Title
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The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: No PPI treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Female or male aged ≥18 years. Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy. Exclusion Criteria: Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator. The ASA classification of physical status ≥ 4 as judged by the investigator. Severe hepatic disease or renal disease Ability to understand and the willingness to sign a written informed consent document. Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. Haemorrhagic disorder. Patients who had a history of gastrectomy or a recurrent lesion. Known or suspected hypersensitivity to any component of any PPI . Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. Known or suspected alcohol, drug or medication abuse. Any condition associated with poor compliance as judged by the investigator. Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. Involvement in the planning and conduct of the study. Previous enrollment in the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>No PPI treatment should given after the initial allocation. Patient will be admitted, and ESD will be performed. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg. | Drug: No PPI treatment<br>* No PPI treatment before ESD procedure<br>|
| Experimental: Esomeprazole group<br>Esomeprazole should start as soon as possible after the initial allocation. During the 7 days of p.o. treatment, patient will be admitted, and ESD will be performed as soon as completing the p.o. treatment. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg. | Drug: Esomeprazole<br>* Proton pump inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total bleeding rate according to grading of intraoperative bleeding during ESD procedure | ≥grade 1 means bleeding | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of coagrasper usage which reflects grade of major bleeding |  | 1 day | 
| Post-ESD ulcer quality as indicated in description | Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation. | 1 day | 
| Intra-procedure injury to muscularis propria including perforation. | Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation. | 1 day | 
| Mean haemoglobin reduction between intervention and control group. |  | 1 day | 
| Delayed bleeding rate as indicated by haematemesis and melaena |  | 30 days | 
| The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic submucosal dissection, proton pump inhibitor, bleeding