Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
- Registration Number
- NCT06526455
- Lead Sponsor
- Shicai Ye
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 196
- Meets surgical indications for ESD
- Age 18-70 years, regardless of gender
- Normal coagulation
- ESD Postoperative ulcers ≤3cm
- Voluntary participation in the study
- Patients with severe complications or failure to achieve curative resection after gastric ESD surgery need supplementary surgery
- Women who are pregnant or breastfeeding, or who may conceive during clinical trials
- The patient has other serious organic diseases that affect the evaluation of the study, such as severe liver disease, heart disease, renal disease, malignant neoplasm and alcoholism
- Patients who need to take antiplatelet and NSAIDS drugs for a long period of time
- Co-administration of unspecified anti-ulcer drugs during the trial period;Allergic reactions to vornoxan, aluminium phosphate gel or esomeprazole
- Patients with no capacity for autonomous behaviors, unable to correctly express their main complaint, such as those with mental illness, severe neurosis, and unable to cooperate with this experiment
- ESD Postoperative ulcers >3cm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Vonoprazan Vonorasan、tablet、20mg、qd、Days 3 to 56 Control group Esomeprazole Esomeprazole 、tablet、20mg、Days 3 to 56
- Primary Outcome Measures
Name Time Method Rate of ulcer reduction 2nd and 8th week post-dose 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%
- Secondary Outcome Measures
Name Time Method Rate of ulcer healing 2nd and 8th week post-dose Healing rate = number of cases with scarring/total number of cases × 100 per cent
Size of ulcer 2nd and 8th week post-dose Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2)
Postoperative symptom relief rate 2th week post-dose Number of persons in remission/total
Rate of bumpy 2nd and 8th week post-dose Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent
Rate of delayed hemorrhage 2th week post-dose Rate of delayed hemorrhage=Number of haemorrhages/total
Quality of ulcer healing 2nd and 8th week post-dose Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing
Trial Locations
- Locations (4)
Yellow River Sanmenxia Hospital
🇨🇳Sanmenxia, Henan, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Maoming People's Hospital
🇨🇳Maoming, Guangdong, China
The First Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China