Efficacy of Vonoprazan in Management of Post Endoscopic Variceal Ligation Ulcer
- Conditions
- Digestive System
- Registration Number
- PACTR202207793488326
- Lead Sponsor
- General Organization for Teaching Hospitals and Institutes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 300
Patients above the age of 18 years and below the age of 65 years who will be presented for elective band ligation of esophageal varices.
1.Patients who had been subjected to injection sclerotherapy sessions.
2.Endoscopically confirmed pre-existing esophageal ulcers.
3.Barret's esophagus.
4.Previous surgical anti-reflux procedure.
5.Peptic ulcer disease diagnosed at the time of endoscopy.
6.Cardiofundal varices.
7.Pregnancy and lactation.
8.Diabetic patients and patients with advanced systemic disease as heart failure renal failure or any depleting disease that might affect healing process and\or life expectancy and as well those with suspected malignancy.
9.Allergy or past adverse reaction to investigated drugs.
10.Patients who will refuse to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Post endoscopic Variceal ligation ulcer: presence (Yes or No), number, and size [ Time Frame: At 2 weeks after intervention (EvL)]<br>a.presence of post ligation ulcer (Yes/NO)<br>b.the number of ulcers if present.<br>c.the maximum dimension of an ulcer (if present) in millimeter.<br>2.Number of participants with Vonoprazan-related adverse events as assessed by TRAEs grouped by Medical Dictionary for Regulatory Activities version 19.1
- Secondary Outcome Measures
Name Time Method 1.Symptoms related to EVL including: chest pain, dysphagia and vomiting<br>2.Patients compliance<br>