Gastric Mucosal Lesion
Conditions
Keywords
OsrhCT, Recombinant Human Chymotrypsin
Brief summary
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.
Detailed description
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.
Interventions
DRUGRecombinant Human Chymotrypsin(OsrhCT) 4000U
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
DRUGDimethicone emulsion 4ml
Dimethicone emulsion，produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.
Sponsors
Beijing Friendship Hospital
Healthgen Biotechnology Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients indicated for gastroscopy examination; 2. Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent; 3. Able to complete the research according to the requirements of the experimental plan; 4. Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug; 5. Aged 18-75 years (inclusive), male or female;
Exclusion criteria
1. Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination; 2. Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc; 3. Subjects accessed not to stand sedation anesthesia or gastroscopy examination; 4. Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices; 5. Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery; 6. Abnormal laboratory values:: alanine aminotransferase (ALT)\>2 × ULN, aspartate aminotransferase (AST)\>2 × ULN, serum creatinine\>1.5 × ULN; 7. Female subjects who had unprotected sex within 14 days prior to screening; 8. Pregnant or breastfeeding women; 9. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months; 10. Any other conditions deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total visibility score (TVS) evaluated by blinded endoscopists | Through study completion, an average of 3 months | Total visibility scorecounted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach | Through study completion, an average of 3 months | Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus. |
| The amount of water flushed for satisfactory observation of the upper gastrointestinal tract | during diagnostic upper endoscopy, up to 1 hour | Amount of water used to allow an suitable visualization of gastric mucosa |
| Duration of endoscopy | during diagnostic upper endoscopy, up to 1 hour | Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope) |
| Incidence of adverse events | up to 1 week | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Establishment and method validation of the criteria for mucosal visibility score | Through study completion, an average of 3 months | 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 (lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum) evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists. |
Countries
China
Outcome results
None listed