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Pantoprazole After Prophylactic Endoscopic Variceal Treatment

NCT07248722 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-04-01

No results posted yet for this 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).

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • General Hospital of Shenyang Military Region

    lead OTHER

Principal Investigators

  • Xingshun Qi · Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07248722 on ClinicalTrials.gov