Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

March 24, 2026 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension

This study aims to evaluate the impact of high-risk factors-such as elevated portal venous pressure, concurrent large extra-luminal vessels, portal vein thrombosis, and prominent portosystemic shunts-on the efficacy of endoscopic therapy. By comparing with interventional treatment, the goal is to optimize the clinical management protocol for esophageal and gastric varices, enhance the therapeutic outcomes of portal hypertension-related esophageal and gastric varices, and improve patient prognosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Enrolled were patients who presented to Zhongshan Hospital, Fudan University and other study centers due to esophagogastric variceal bleeding secondary to portal hypertension between December 2025 and December 2026.

Description

Inclusion Criteria:

  • Admitted due to gastrointestinal bleeding and clinically diagnosed with portal hypertension
  • Underwent imaging examinations and gastroscopy within one week after admission
  • Gastroscopy revealed the presence of esophageal and/or gastric varices
  • Age over 18 years

Exclusion Criteria:

  • Previous history of liver transplantation
  • Imaging or gastroscopy findings indicated ulcers or other causes of gastrointestinal bleeding
  • Concurrent severe life-threatening diseases involving the circulatory, hematological, or respiratory systems
  • Difficulty in follow-up, or lack of essential medical history information, imaging data, or other necessary records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
TIPS treatment group
The patient underwent Transjugular Intrahepatic Portosystemic Shunt (TIPS) after admission
Endoscopic treatment group
The patient only received endoscopic treatment after admission.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1-year gastrointestinal rebleeding rate
Time Frame: 1 year after the treatment.
Time from initial variceal bleeding treated with endoscopy or TIPS to recurrent variceal rupture and bleeding due to portal hypertension (at least 120 hours)
1 year after the treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2-month and 6-month gastrointestinal rebleeding rates
Time Frame: 2 months and 6 months after the treatment
Time from initial variceal bleeding treated with endoscopy or TIPS to recurrent variceal rupture and bleeding due to portal hypertension (at least 120 hours)
2 months and 6 months after the treatment
Indicators in the Child-Pugh classification include the progression of ascites and changes in bilirubin levels.
Time Frame: 1, 2, 6, and 12 months after the treatment.
Depth of abdominal fluid dark area detected by abdominal ultrasound; changes in serum bilirubin levels in liver function tests.
1, 2, 6, and 12 months after the treatment.
Changes of portal vein thrombosis
Time Frame: 6 and 12 months after the treatment.
Evaluate the occurrence, recanalization, and other changes in thrombosis every 6 months using portal CTA and ultrasound.
6 and 12 months after the treatment.
Liver cancer
Time Frame: Up to 12 months after the treatment.
Hepatocellular carcinoma or cholangiocarcinoma
Up to 12 months after the treatment.
Liver transplantation
Time Frame: Up to 12 months after the treatment.
Based on comprehensive clinical evaluation, liver transplantation is required.
Up to 12 months after the treatment.
Variceal bleeding-related mortality
Time Frame: Up to 12 months after the treatment.
During the follow-up period, deaths caused by variceal rupture and bleeding that occurred within 6 weeks after the bleeding episode and were clearly related to the bleeding, including hemorrhagic shock and multiple organ failure.
Up to 12 months after the treatment.
Liver-related mortality
Time Frame: Up to 12 months after the treatment.
Deaths resulting from variceal rupture and bleeding, liver failure, hepatic encephalopathy, infection, hepatorenal syndrome, etc., excluding deaths due to extrahepatic causes, including: accidental death, cardiovascular events, and deaths caused by other systemic cancers.
Up to 12 months after the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
RenJi Hospital
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai East Hospital
Shanghai Changzheng Hospital
Second Military Medical University
The General Hospital of Northern Theater Command
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2025-835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings