Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection

Phase 4Not Yet RecruitingNCT06526455

Shicai Ye196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

196

Conditions

Ulcers, Gastric

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meets surgical indications for ESD * Age 18-70 years, regardless of gender * Normal coagulation * ESD Postoperative ulcers ≤3cm * Voluntary participation in the study Exclusion Criteria: * 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

Locations (4)

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

Outcomes

Primary Outcomes

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%