The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD
Not Applicable
Completed
- Conditions
- Stomach Neoplasms
- Interventions
- Registration Number
- NCT02730533
- Lead Sponsor
- Xijing Hospital of Digestive Diseases
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group No PPI treatment 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. Esomeprazole group Esomeprazole 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.
- Primary Outcome Measures
Name Time Method The total bleeding rate according to grading of intraoperative bleeding during ESD procedure 1 day ≥grade 1 means bleeding
- Secondary Outcome Measures
Name Time Method The frequency of coagrasper usage which reflects grade of major bleeding 1 day Post-ESD ulcer quality as indicated in description 1 day Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.
Intra-procedure injury to muscularis propria including perforation. 1 day Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.
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
Trial Locations
- Locations (1)
Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China