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Clinical Trials in China / NCT07248722
Enrolling by invitation Not applicable

Pantoprazole After Prophylactic Endoscopic Variceal Treatment

NCT07248722 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Shenyang Military Region
Phase
Not applicable
Started
2026-03-27
Last updated
2026-04-01

Condition(s) studied

Esophageal and Gastric VaricesLiver Cirrhosis

Investigational drug(s) / intervention(s)

Pantoprazole

Pantoprazole: Participants assigned to the pantoprazole group should receive intravenous pantoprazole 40 mg once daily immediately after EVT for a duration of 1 to 7 days until discharge, followed by oral pantoprazole 40 mg once daily until the total duration is 2 weeks. Patients assigned to the control group should not receive any acid suppression.

Study summary

Traditionally, it is considered that gastric acid delays ulcer healing, and acid suppression can reduce the risk of post-banding ulcer bleeding and promote mucosal healing at the ulcer site. A systematic review and meta-analysis performed by our team demonstrated that acid suppression significantly reduced the incidence of gastrointestinal bleeding (GIB) following prophylactic endoscopic variceal ligation (EVL), but had no significant effect on the incidence of mortality, adverse events, or length of stay. Similarly, another systematic review and meta-analysis performed by Lin et al. indicated that proton pump inhibitor (PPI) significantly reduced the incidence of GIB after therapeutic or prophylactic endoscopic variceal treatment (EVT), and the efficacy of PPI in reducing post-EVT GIB is related to the duration of PPI. However, previous studies have indicated that long-term use of PPI may increase the risk of bacterial infections and hepatic encephalopathy in patients with cirrhosis. Therefore, current guidelines suggest that PPI should be discontinued after EVT, unless the patient has a clear indication for PPI. However, the quality of evidence is poor due to the small sample sizes, predominantly retrospective designs, and inconsistencies in follow-up duration of previous studies. In current clinical practice, most physicians still prefer to use PPI routinely after EVT to prevent post-EVT GIB. Given the ongoing controversy regarding the routine use of PPI after EVT, we plan to conduct a multicenter randomized controlled trial to to explore the effect of PPI after prophylactic EVT on the incidence of short-term GIB, adverse events, and mortality in patients with cirrhosis and esophagogastric varices (EGV).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. patients who are diagnosed with liver cirrhosis by liver biopsy and/or a combination of clinical manifestation, laboratory tests, and imaging examinations; 2. patients who are diagnosed with esophageal varix (EV) or gastroesophageal varix 1 (GOV1) by endoscopy; 3. patients who undergo EVT for EV and/or gastric varices; 4. patients who undergo EVT for either primary or secondary prophylaxis of EVB; 5. patients aged ≥18 years, regardless of gender; 6. patients who sign their informed consent forms. Exclusion Criteria: 1. patients with a diagnosis of acute variceal bleeding before enrollment; 2. patients with definite indications for PPI (reflux esophagitis, peptic ulcer, Zollinger-Ellison syndrome, etc.) at admission; 3. patients with definite indications for PPI (reflux esophagitis, peptic ulcer, etc.) discovered during EVT; 4. patients who are allergic to PPI or had intolerable adverse reactions to PPI previously; 5. patients with severe cardiovascular diseases, cerebrovascular diseases, or renal impairment; 6. patients with severe hematological disorders; 7. patients who were pregnant, lactating, or preparing for pregnancy; 8. patients who have already participated in other clinical trials.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) Shenyang Liaoning

On this site

📄 Protonix (pantoprazole) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248722 on ClinicalTrials.gov ↗ ← All trials in China