The Effect of K-CAB (tegoprazan) for Prevention of Artificial Ulcers bleeding after Endoscopic Submucosal Dissectio

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0006850
• Lead Sponsor: Kyung Hee University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1) Those who are between 20 and 75 years of age as of the date of obtaining written consent
2) Patients who have been diagnosed with gastric adenoma or early gastric cancer and need to undergo endoscopic submucosal dissection (ESD) for treatment.
3) In any of the following cases
-Gastric adenoma
-Undifferentiated early gastric cancer of less than 2.0 cm, limited to the mucous membrane and without ulcers
-Differentiated early gastric cancer limited to the mucous membrane regardless of the size of the lesion and without ulcers
-Differentiated early gastric cancer of less than 3.0 cm limited to the mucous membrane and accompanied by ulcers
-Differentiated early gastric cancer less than 3.0 cm invading the submucosal layer less than 500 µm and not accompanied by ulcers
4) A person who can understand and follow the instructions and can participate in the entire clinical trial period
5) Those who voluntarily decided to participate and gave written consent to the clinical trial subject consent form
6) Those who agree to use contraceptive methods (including medically impossible conditions) during the clinical trial period

Exclusion Criteria

1) Those who have confirmed gastrointestinal bleeding or perforation in the upper gastrointestinal endoscopy performed during screening
2) Those who have undergone major surgery that may affect gastric acid secretion in the past.
3) Those with Zollinger-Ellison syndrome or other gastric acid secretion disorders or a history
4) Those who cannot follow-up upper gastrointestinal endoscopy
5) Those who have hypersensitivity reactions to tegoprazan or proton pump inhibitors or benzimidazoles and have a history of such reactions
6) Those who are taking atazanavir, nelfinavir, or rilpivirine-containing preparations
7) Pregnant or lactating women
8) Uncontrolled cardiopulmonary disease, renal disease, liver disease, endocrine disease, cranial nerve disease, etc.
9) When it is difficult to conduct appropriate research due to cognitive impairment, intellectual disability, mental illness, etc.
10) When taking PPI, H2 blocker, or prokinetics within 2 weeks before endoscopic submucosal dissection
11) In case of taking antiplatelet drugs or anticoagulants within 1 week before endoscopic submucosal dissection
12) In case of continuous use of corticosteroids, NSAIDs, aspirin and other antiplatelet drugs, anticoagulants and contraindicated drugs during the clinical trial period
13) When AST, ALT, ALP, GGT, and total bilirubin levels are more than twice the upper limit reference value (UNL), or creatinine levels are more than twice the upper limit reference value
14) Those with a history of malignant tumors within the past 5 years
15) In case of thrombocytopenia or dysfunction (=20,000/µL)
16) Those who participated in other clinical trials within 12 weeks of Visit 2 (random assignment date)
17) Patients with a history of alcohol abuse
18) Except the above, those who have clinically significant findings that the investigator judges to be inappropriate for this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-ESD bleeding rate

Secondary Outcome Measures

Name	Time	Method
Incidence rate of acute bleeding;Rate of delayed bleeding;Bleeding rate according to H. pylori infection