Acid-suppression Drugs After Prophylactic Endoscopic Variceal Treatment of Esophagogastric Variceal Bleeding in Cirrhosis

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Not yet enrolling

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

Treatments: Drug: ASD

Study type: Interventional

Funder types: Other

Identifiers

NCT07248722

XHNKKY-EVT-ASD

Details and patient eligibility

About

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 bleeding following prophylactic endoscopic variceal treatment (EVT), 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 PPIs significantly reduced the incidence of bleeding after therapeutic or prophylactic EVT, and the efficacy of PPIs in reducing post-EVT bleeding is related to the duration of PPIs. However, previous studies have indicated that long-term use of acid-suppression drugs (ASD) may increase the risk of bacterial infections and hepatic encephalopathy in patients with cirrhosis. Therefore, current guidelines suggest that ASD should be discontinued after EVT, unless the patient has a clear indication for acid suppression. 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 ASD routinely after EVT to prevent post-EVT bleeding. Given the ongoing controversy regarding the routine use of ASD after EVT, we plan to conduct a multicenter randomized controlled trial to evaluate the effects of the use of ASD after prophylactic EVT on short-term bleeding, adverse events, and mortality in patients with cirrhosis.

Full description

Overall, 210 patients with cirrhosis undergoing prophylactic EVT will be enrolled. They will be randomly assigned at a ratio of 1:1 to the ASD group and non-ASD group. The primary endpoint is 6-week bleeding. Secondary endpoints include 6-week all-cause mortality and adverse events (retrosternal pain/discomfort, nausea/vomiting, heartburn/acid regurgitation, fever, diarrhea, abdominal pain, etc.).

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosis of liver cirrhosis confirmed by liver biopsy and/or a combination of clinical manifestation, laboratory, and imaging examinations;
2. endoscopically confirmed esophagogastric varices and undergoing EVT;
3. patients aged ≥18 years, regardless of gender;
4. sign the informed consent form.

Exclusion criteria

1. diagnosis of acute upper gastrointestinal bleeding upon admission, with clinical manifestations such as hematemesis, melena, and/or hematochezia;
2. definite indications for acid suppression upon admission: reflux esophagitis, peptic ulcer, Zollinger-Ellison syndrome, etc.;
3. definite indications for acid suppression discovered during EVT: reflux esophagitis, peptic ulcer, etc.;
4. allergy to ASD or previous intolerable adverse reactions to ASD;
5. severe cardiovascular or cerebrovascular diseases or renal impairment;
6. severe hematological disorders;
7. women preparing for pregnancy or those who were pregnant and lactating;
8. patients who have already participated in other clinical trials.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

ASD group

Experimental group

Treatment:

Drug: ASD

non-ASD group

No Intervention group