Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
NCT Number: NCT06526455
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Ulcers, Gastric
Interventions: DRUG: Vonoprazan|DRUG: Esomeprazole
Sponsor: Shicai Ye
Collaborators: First Affiliated Hospital of Jinan University|The First Affiliated Hospital of Guangzhou Medical University|Maoming People's Hospital|Yellow River Sanmenxia hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2029-06-30
Locations: The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China|The First Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China|Maoming People's Hospital, Maoming, Guangdong, China|Yellow River Sanmenxia Hospital, Sanmenxia, Henan, China

Summary:
The purpose of this clinical trial is to find out the effectiveness of voronasan in combination with aluminum phosphate gel in the treatment of post-operative ESD ulcers. It will also find out about the safety of vunorasan in combination with aluminum phosphate gel. The main questions it aims to answer are:

1. Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
2. What medical problems do participants have when taking drug vonorasan in combination with aluminum phosphate gel? Researchers compared the drug voransen in combination with aluminum phosphate gel to esomeprazole in combination with aluminum phosphate gel to see if voransen in combination with aluminum phosphate gel worked better for post-operative ESD ulcers.

Participants will:

Intravenous lansoprazole 1-3 days after ESD and oral voronasan combined with aluminum phosphate gel or esomeprazole combined with aluminum phosphate gel 3-56 days after ESD.

Record their symptoms, endoscopic ulcer grading, ulcer size and Calculate ulcer healing rate at weeks 2 and 8.

Primary Outcome Measures: Rate of ulcer reduction, Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100% Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100%, 2nd and 8th week post-dose
Secondary Outcome Measures: Size of ulcer, Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2), 2nd and 8th week post-dose|Rate of ulcer healing, Healing rate = number of cases with scarring/total number of cases × 100 per cent, 2nd and 8th week post-dose|Rate of bumpy, Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent, 2nd and 8th week post-dose|Quality of ulcer healing, Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing, 2nd and 8th week post-dose|Rate of delayed hemorrhage, Rate of delayed hemorrhage=Number of haemorrhages/total, 2th week post-dose|Postoperative symptom relief rate, Number of persons in remission/total, 2th week post-dose