Esophageal and Gastric VaricesNCT07248722
Pantoprazole After Prophylactic Endoscopic Variceal Treatment
A study testing Pantoprazole in people with Esophageal and Gastric Varices and Liver Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and Gastric Varices, Liver Cirrhosis
- What is being tested?
- Pantoprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840
About this study
Official title: Pantoprazole After Prophylactic Endoscopic Variceal Treatment in Cirrhosis (PPEC): Protocol of a Multicenter Randomized Controlled Trial
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).
Read the detailed description
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.
- Conditions
- Esophageal and Gastric Varices, Liver Cirrhosis
- Being tested
- Pantoprazole
- Keywords
- esophageal and gastric varices, endoscopic therapy, adverse events, liver cirrhosis, proton pump inhibitor
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
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 group | Role | What they receive |
|---|---|---|
| pantoprazole group | Experimental | Not described Receives: Drug: Pantoprazole |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of 6-week GIB
binary outcome
Measured: 6 weeks
Secondary outcomes (3)
Proportion of 6-week all-cause death
time-to-event outcome
Measured: 6 weeks
Proportion of 6-week adverse events
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.
Measured: 6 weeks
hierarchical composite endpoint of all-cause death or 6-week GIB
The hierarchy of the composite endpoint is death due to all cause (time-to-event) and then 6-week GIB (binary).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start27 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, Study director, Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248722
- Sponsor's protocol ID
- XHNKKY-PPEC
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32088712Zhang 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.
PubMed 36741070Zhu 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.
PubMed 29564926
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pantoprazole After Prophylactic Endoscopic Variceal Treatment in Cirrhosis (PPEC): Protocol of a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07248722
- Acronym / sponsor ID
- XHNKKY-PPEC
- Conditions
- Esophageal and Gastric Varices, Liver Cirrhosis
- Keywords
- esophageal and gastric varices, endoscopic therapy, adverse events, liver cirrhosis, proton pump inhibitor
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole group | Experimental | Drug: Pantoprazole |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PantoprazoleParticipants 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. | Drug | pantoprazole group |
Primary outcome
Proportion of 6-week GIB
Time frame: 6 weeks
binary outcome
3 secondary outcomes
Proportion of 6-week all-cause death
Time frame: 6 weeks
Proportion of 6-week adverse events
Time frame: 6 weeks
hierarchical composite endpoint of all-cause death or 6-week GIB
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Results publication: PubMed 32088712Lin 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.
- Results publication: PubMed 36741070Zhang 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.
- Results publication: PubMed 29564926Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingshun Qi study director
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantoprazole in people with Esophageal and Gastric Varices and Liver Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of 6-week GIB (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.