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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
74
Proton pump inhibitor
No PPI treatment before ESD procedure
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
The total bleeding rate according to grading of intraoperative bleeding during ESD procedure
≥grade 1 means bleeding
Time frame: 1 day
The frequency of coagrasper usage which reflects grade of major bleeding
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Mean haemoglobin reduction between intervention and control group.
Time frame: 1 day
Delayed bleeding rate as indicated by haematemesis and melaena
Time frame: 30 days
The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.
Time frame: 30 days
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