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

NCT ID: NCT07248722

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief 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 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.

Detailed 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.).

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASD group

Group Type: EXPERIMENTAL

ASD

Intervention Type: DRUG

Patients should receive intravenous esomeprazole 40 mg/d immediately after EVT for 3 to 7 days until discharge, followed by oral keverprazan 20 mg/d until the total duration of acid suppression is 2 weeks.

non-ASD group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ASD

Patients should receive intravenous esomeprazole 40 mg/d immediately after EVT for 3 to 7 days until discharge, followed by oral keverprazan 20 mg/d until the total duration of acid suppression is 2 weeks.

Intervention Type: DRUG

Other Intervention Names

acid-suppression drugs

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Xingshun Qi

Director of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingshun Qi

Role: STUDY_DIRECTOR

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

Locations

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

Shenyang, Liaoning, China

Countries

China

Central Contacts

Xingshun Qi

Role: CONTACT

xingshunqi@126.com

+8618909881019

Sai Guan

Role: CONTACT

guansai2002@163.com

+8615609832985

Facility Contacts

Xingshun Qi

Role: primary

xingshunqi@126.com

+8618909881019

Sai Guan

Role: backup

guansai2002@163.com

References

Lin L, Cui B, Deng Y, Jiang X, Liu W, Sun C. The Efficacy of Proton Pump Inhibitor in Cirrhotics with Variceal Bleeding: A Systemic Review and Meta-Analysis. Digestion. 2021;102(2):117-127. doi: 10.1159/000505059. Epub 2020 Feb 21.

Reference Type: RESULT

PMID: 32088712 (View on PubMed)

Zhang YY, Wang L, Shao XD, Zhang YG, Ma SZ, Peng MY, Xu SX, Yin Y, Guo XZ, Qi XS. Effects of postoperative use of proton pump inhibitors on gastrointestinal bleeding after endoscopic variceal treatment during hospitalization. World J Gastrointest Surg. 2023 Jan 27;15(1):82-93. doi: 10.4240/wjgs.v15.i1.82.

Reference Type: RESULT

PMID: 36741070 (View on PubMed)

Zhu J, Qi X, Yu H, Su C, Guo X. Acid suppression in patients treated with endoscopic therapy for the management of gastroesophageal varices: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2018 Jun;12(6):617-624. doi: 10.1080/17474124.2018.1456918. Epub 2018 Apr 4.

Reference Type: RESULT

PMID: 29564926 (View on PubMed)

Other Identifiers

XHNKKY-EVT-ASD

Identifier Type: -

Identifier Source: org_study_id