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Enrolling by Invitation

NCT Number: NCT07248722

Pantoprazole After Prophylactic Endoscopic Variceal Treatment

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).

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Key information

Conditions

Esophageal and Gastric Varices Digestive System Diseases Esophageal Diseases Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shenyang, Liaoning, 110840, China

About this study

Overall, 208 patients with cirrhosis and EGV undergoing prophylactic EVT will be enrolled. They will be randomly assigned at a ratio of 1:1 to the pantoprazole group and the control group. The primary endpoint is 6-week GIB. The secondary endpoints include: (1) 6-week all-cause death; (2) hierarchical composite endpoint of all-cause death or 6-week GIB. The safety outcome is 6-week adverse events, which contains complications potentially related to EVT or PPI within 6 weeks after EVT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who are diagnosed with liver cirrhosis by liver biopsy and/or a combination of clinical manifestation, laboratory tests, and imaging examinations;
  • patients who are diagnosed with esophageal varix (EV) or gastroesophageal varix 1 (GOV1) by endoscopy;
  • patients who undergo EVT for EV and/or gastric varices;
  • patients who undergo EVT for either primary or secondary prophylaxis of EVB;
  • patients aged ≥18 years, regardless of gender;
  • patients who sign their informed consent forms.

Exclusion criteria

  • patients with a diagnosis of acute variceal bleeding before enrollment;
  • patients with definite indications for PPI (reflux esophagitis, peptic ulcer, Zollinger-Ellison syndrome, etc.) at admission;
  • patients with definite indications for PPI (reflux esophagitis, peptic ulcer, etc.) discovered during EVT;
  • patients who are allergic to PPI or had intolerable adverse reactions to PPI previously;
  • patients with severe cardiovascular diseases, cerebrovascular diseases, or renal impairment;
  • patients with severe hematological disorders;
  • patients who were pregnant, lactating, or preparing for pregnancy;
  • patients who have already participated in other clinical trials.

Treatment and study plan

Pantoprazole

Drug

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.

Primary outcomes

  1. Proportion of 6-week GIB

    Time frame: 6 weeks

    binary outcome

Secondary outcomes

  1. Proportion of 6-week all-cause death

    Time frame: 6 weeks

    time-to-event outcome

  2. Proportion of 6-week adverse events

    Time frame: 6 weeks

    Proportion of 6-week adverse events (binary outcome) is also the safety outcome, which is defined as complications potentially related to EVT or PPI within 6 weeks after EVT. The complications related to PPI primarily include: (1) clostridium difficile infection; (2) pneumonia; (3) hepatic encephalopathy; (4) spontaneous bacterial peritonitis; and (5) other adverse events. Except for GIB, the complications related to EVT primarily include: (1) retrosternal pain/discomfort; (2) nausea/vomiting; (3) heartburn/acid regurgitation; (4) fever; (5) diarrhea; (6) abdominal pain; and (7) other adverse events.

  3. hierarchical composite endpoint of all-cause death or 6-week GIB

    Time frame: 6 weeks

    The hierarchy of the composite endpoint is death due to all cause (time-to-event) and then 6-week GIB (binary).

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Pantoprazole After Prophylactic Endoscopic Variceal Treatment in Cirrhosis (PPEC): Protocol of a Multicenter Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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