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| ID | Type | Description | Link |
|---|---|---|---|
| 640/RC/KEMU | Other Identifier | IRB King Edward Medical University |
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The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure.
The study will also look at how well vonoprazan is tolerated and if it improves comfort after the procedure.
The main questions this study will answer are:
Does vonoprazan lower the number and severity of ulcers found on endoscopy after EVBL?
Does vonoprazan reduce swallowing pain or chest discomfort compared with placebo?
Is vonoprazan safe and well tolerated in people with liver cirrhosis?
Researchers will compare vonoprazan 20 mg once daily with a placebo (a look-alike tablet that contains no active medicine) to see if vonoprazan works better to prevent these ulcers.
Participants will:
Take vonoprazan or placebo by mouth once daily for 14 days after EVBL.
Return for a follow-up endoscopy about two weeks later to check for ulcers.
Report any symptoms such as pain, nausea, or swallowing difficulty during the study.
Adults aged 18 to 75 years with liver cirrhosis who undergo EVBL will be invited to join. Participants will be randomly assigned to one of two groups, and neither they nor the study doctors will know which treatment they receive (double-blind design).
The study will take place at Mayo Hospital, Lahore, Pakistan, over about six months.
By comparing vonoprazan to placebo, researchers hope to find a better way to protect the esophagus and stomach after EVBL, reduce post-procedure pain, and support faster recovery in people with liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan 20 mg after EVBL | Experimental | Participants in this arm will receive vonoprazan 20 mg orally once daily for 14 days following endoscopic variceal band ligation (EVBL). Vonoprazan is a potassium-competitive acid blocker that provides strong and sustained suppression of gastric acid. The aim is to test whether vonoprazan can help prevent the formation of ulcers that sometimes develop after EVBL and to improve symptoms such as pain or difficulty swallowing. Participants will continue their usual medical care for liver disease. Study staff, participants, and investigators will all remain blinded to treatment allocation until data analysis is complete. |
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| Placebo after EVBL | Placebo Comparator | Participants in this arm will receive a placebo tablet orally once daily for 14 days following endoscopic variceal band ligation (EVBL). The placebo tablet will look identical to the Vonoprazan tablet but contains no active medicine. This group serves as a comparison to determine whether Vonoprazan is more effective than placebo in preventing post-procedural ulcers and reducing symptoms such as swallowing discomfort or chest pain. Participants will receive standard medical care for liver disease and will undergo the same follow-up and assessments as the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan 20 mg | Drug | Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides strong and sustained suppression of gastric acid secretion. In this study, participants will receive vonoprazan 20 mg by mouth once daily for 14 days after endoscopic variceal band ligation (EVBL). The tablets will be taken with water, preferably before breakfast. This dose and duration are based on prior clinical experience in acid-related disorders. The aim is to determine whether vonoprazan prevents the formation of ulcers and reduces post-procedure pain compared with placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers | The proportion of participants who develop visible post-banding ulcers detected on follow-up endoscopy. Ulcers will be assessed using the Lanza Score for gastric mucosal injury, which grades the number and severity of ulcers from 0 (no injury) to 4 (severe injury). A lower Lanza score indicates less mucosal injury. The outcome compares the rate and severity of ulcers between the vonoprazan and placebo groups. | At follow-up endoscopy, 14 ± 1 days after EVBL. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS) | Change in symptom intensity for swallowing pain (odynophagia), difficulty swallowing (dysphagia), and chest discomfort (retrosternal pain), measured using a 100 mm Visual Analog Scale (VAS) where 0 = no pain and 100 = worst possible pain. The change from baseline to day 14 will be calculated. A ≥ 20% reduction in VAS score from baseline will be considered clinically significant. |
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Inclusion Criteria:
Exclusion Criteria:
ICU admission Requirement for mechanical ventilation GCS < 10
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad R Tariq, MBBS,FCPS | Contact | +923337692728 | ibneislam190@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Edward Medical University/Mayo Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
Individual participant data (IPD) will not be shared publicly because this is a single-center academic study conducted at Mayo Hospital, Lahore, with a limited sample size and locally collected data. De-identified summary data and statistical analyses may be made available upon reasonable request to the principal investigator after publication of study results, in accordance with institutional and ethical committee policies.
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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| Placebo | Other | Participants in the placebo group will receive a look-alike oral tablet with no active medicine, once daily for 14 days after EVBL. The placebo will be identical in color, size, and packaging to the Vonoprazan tablet to maintain blinding. This comparator will help determine whether Vonoprazan provides any true benefit in preventing ulcers and improving symptoms beyond standard post-procedure care. |
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| Baseline and 14 ± 1 days after EVBL. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |