Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa. A total of 336 subjects (both male and female) are expected to be enrolled in this trial.
This is a monocentric, double-blind, randomized study involving 336 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with OsrhCT 4000U+ Dimethicone emulsion 4ml , with OsrhCT 8000U+ Dimethicone emulsion 4ml , and with placebo for OsrhCT+ Dimethicone emulsion 4ml. During the examination, each photograph was individually taken in 5 defined areas. The first 30 cases were collected to establish standards and method validation. The visibility score was given by the sum of the score 1-4 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
336
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/vial, freeze-dried powder
Dimethicone emulsion,produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA Central Theatre General Hospital
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
the Central Hospital of Wuhan
Wuhan, Hubei, China
Total visibility score (TVS) evaluated by blinded endoscopists
"Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum.
Time frame: Through study completion, an average of 3 months
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach
Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus.
Time frame: Through study completion, an average of 3 months
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract
Amount of water used to allow an suitable visualization of gastric mucosa
Time frame: during diagnostic upper endoscopy, up to 1 hour
Duration of endoscopy
Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope)
Time frame: during diagnostic upper endoscopy, up to 1 hour
Incidence of adverse events
Number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
Time frame: up to 1 week
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Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China