Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207793488326 Date of Approval: 22/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Vonoprazan in Management of Post Endoscopic Variceal Ligation Ulcer
Official scientific title Efficacy of Potassium-Competitive Acid Blockers in Management of Post Endoscopic Variceal Ligation Ulcer
Brief summary describing the background and objectives of the trial Gastroesophageal variceal bleeding is one of the most common complications of liver cirrhosis (1) . Endoscopic variceal ligation (EVL) is a widely accepted treatment of bleeding and involves fewer complications (2); such as heartburn, chest pain, transient dysphagia, odynophagia, stricture formation, worsening of portal hypertensive gastropathy and bacteremia (3). Most of this complication are related to post-EVL ulcers (4). The behavior of post-ligation ulcer appears benign because of the instrument design which sucks up mucosa and submucosa leading only to the formation of superficial ulcers. They heal by fibrosis, entrapping only the mucosa, and submucosal venous channels, leaving the muscle layer unaffected (5). However bleeding from EVL-induced ulcer formation is a known serious complication of this procedure, with a mortality rate of 27.3% (6). Many treatment modalities have been used to control post band ulcer bleeding, such as band local injection of epinephrine or cyanoacrylate, balloon tamponade, stent placement and ligation of the ulcerated bleeding site (3). However, there is no optimal management has been described for it yet (3, 7). Few data exist regarding adjuvant therapy for EVL. The few groups who have attempted to determine if adjuvant therapy reduces complications have reported mixed results (7). Treatment been mostly empirical with drugs used for peptic ulcer diseases (4). Sucralfate has a significant role in decreasing the rate of occurrence of post banding ulcers and as well their size (8). Several studies have reported that proton pump inhibitors (PPIs) decrease the size of post-EVL ulcers (9, 10). Vonoprazan (Takeda Pharmaceutical Co., Tokyo, Japan) is a novel oral potassium-competitive acid blocker with strong and sustained acid-inhibitory activity (11), and compared with PPI, it has a superior effect in Helicobacter pylori eradication (12, 13) and a noninferior effect in acid-related diseases (14-16). The aim of this study is to compare V
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/07/2022
Actual trial start date
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HSH00040 General Organization for Teaching Hospitals and Institutes GOTHI
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vonoprazan 20 mg once before breakfast two weeks The patient will be given nothing by mouth for the following six hours and then only oral fluids will be allowed for the following 24 hours then a semisolid diet for the next few days. All patients will stay in the hospital for about 4 hours following the procedure and then will be discharged on their medication Vonoprazan 20 mg once before breakfast for 14 days. Vonoprazan (Takeda Pharmaceutical Co., Tokyo, Japan) is a novel oral potassium-competitive acid blocker with strong and sustained acid-inhibitory activity 100
Experimental Group Pantoprazole 40 mg before breakfast two weeks The patient will be given nothing by mouth for the following six hours and then only oral fluids will be allowed for the following 24 hours then a semisolid diet for the next few days. All patients will stay in the hospital for about 4 hours following the procedure and then will be discharged on their medication ( Pantoprazole 40 mg before breakfast for 14 days 100
Control Group Placebo Placebo tablet before breakfast two weeks The patient will be given nothing by mouth for the following six hours and then only oral fluids will be allowed for the following 24 hours then a semisolid diet for the next few days. All patients will stay in the hospital for about 4 hours following the procedure and then will be discharged on their medication Placebo before breakfast for 14 days 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2022 General Organization for Teaching Hospitals and Institutes GOTHI
Ethics Committee Address
Street address City Postal code Country
16 A, Qasr Al-Agni, Sayeda Zeinab Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Post endoscopic Variceal ligation ulcer: presence (Yes or No), number, and size [ Time Frame: At 2 weeks after intervention (EvL)] a. presence of post ligation ulcer (Yes/NO) b. the number of ulcers if present. c. the maximum dimension of an ulcer (if present) in millimeter. 2. Number of participants with Vonoprazan-related adverse events as assessed by TRAEs grouped by Medical Dictionary for Regulatory Activities version 19.1 During the 2 weeks of medication use
Secondary Outcome 1. Symptoms related to EVL including: chest pain, dysphagia and vomiting 2. Patients compliance During the 2 weeks of medication use
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mahalla Liver Teaching Hospital GOTHI Almahalla Alkobra at manshiat elbakry Almahalla alkobra Egypt
Shebin ElkomTeaching Hospital GOTHI Shebin ElkomTeaching Hospital Shebin Elkom Egypt
Al Azhar university Hospital Alhusin and Bab Alsharya Hospital cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moataz Yousry 20 st Abu bakr Elsedik hay elshagara tanta gharbia Tanta 31528 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor General Organization for Teaching Hospitals and Institutes 16 A, Qasr Al-Agni, Sayeda Zeinab Cairo Governorate Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Ghoneim Minia Elkamh Sharkia Egypt
Sayed Ammar Ashmon Menofya Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moataz Yousry moataz9999@gmail.com +201026896585 20 st Abu bakr Elsedik hay elshagara tanta gharbia
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer at Al Azhar faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Yousry Abo Amer Dryousryaboaamer@hotmail.com +201007910734 tanta Elmaarad
City Postal code Country Position/Affiliation
Tanta Egypt prof at GOTHI
Role Name Email Phone Street address
Public Enquiries Abdelghany Aish abdelghanyaish@gmail.com +201286775067 Shebin elkom
City Postal code Country Position/Affiliation
Shebin Elkom Egypt fellow at GOTHI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 2 years following article publication To achieve the aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information