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Efficacy and safety of Keverprazan hydrochloride in the treatment of ulcers after endoscopic submucosal dissection (ESD): a prospective, multicenter, single-arm, exploratory clinical study

Efficacy and safety of Keverprazan hydrochloride in the treatment of ulcers after endoscopic submucosal dissection (ESD): a prospective, multicenter, single-arm, exploratory clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083896
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-05-10
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after gastric ESD surgery

Interventions

Experimental group:Use Keverprazan hydrochloride Using Keprazole Hydrochloride

Sponsors

Shenjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 20-70 years, gender is not limited; 2) meet the surgical indications for endoscopic gastricendoscopic submucosal dissection (ESD) treatment; 3) Normal coagulation function; 4) Subjects who fully understand the content of the trial, participate in the trial voluntarily and are able to complete the trial process, and sign an informed consent form. 4) Subjects who fully understand the content of the trial, are willing to participate in the trial and are able to complete the trial process, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients who have undergone endoscopic total mesotheliotomy; 2) patients with diabetes mellitus, cirrhosis of the liver (coagulation abnormalities), blood disorders causing coagulation abnormalities diseases, and autoimmune diseases that may cause delayed healing of ulcers; 3) patients who have used antithrombotic drugs (aspirin, clopidogrel, heparin, etc.), NSAIDs, and other medications within 4 weeks prior to surgery, and the need to resume the use of these medications in the immediate postoperative period; 4) History of gastric surgery; 5) Serious complications after gastric ESD or failure to achieve curative resection requiring additional surgery; 6) pregnant and lactating women, and those who may conceive or prepare for pregnancy during the clinical trial; 7) those who have had an allergic reaction to keplasen hydrochloride; 8) Incompetent, unable to express their complaints correctly, such as mental illness, severe neurological disorders, and unable to cooperate with the trial. 9) Participating in other drugs/devices clinical studies within 3 months prior to enrollment and using the test drugs/devices. 10) Any other person who, in the opinion of the investigator, is not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
The proportion of patients confirmed by endoscopic examination to have ulcer healing 8 weeks after surgery;

Secondary

MeasureTime frame
The proportion of patients confirmed by endoscopic examination to have ulcer healing 4 weeks after surgery;The incidence of delayed bleeding within 4 weeks after surgery;The incidence of delayed bleeding within 8 weeks after surgery;

Countries

China

Contacts

Public ContactSun Siyu

Shengjing Hospital of China Medical University

sunsy@sj-hospital.org+86 189 4025 1329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026