Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

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: Not yet recruiting
• Conditions: Portal Hypertension; Esophageal Varices; Gastric Varices; Gastroesophageal Varices Hemorrhage

• Study Type: Observational
• Enrollment (Estimated): 1066

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
1-year gastrointestinal rebleeding rate	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

Outcome Measure	Measure Description	Time Frame
2-month and 6-month gastrointestinal rebleeding rates	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.	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	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	Hepatocellular carcinoma or cholangiocarcinoma	Up to 12 months after the treatment.
Liver transplantation	Based on comprehensive clinical evaluation, liver transplantation is required.	Up to 12 months after the treatment.
Variceal bleeding-related mortality	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	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

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: 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

Study Major Dates

• Study Start (Estimated): March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID 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