Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

NCT07502729 | Not Yet Recruiting

• 1 other identifier: B2025-835
• Study Type: observational
• Target: 1,066
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Portal Hypertension; Gastroesophageal Varices Hemorrhage; Gastric Varices; Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 2-month and 6-month gastrointestinal rebleeding rates

  2 months and 6 months after the treatment

• Indicators in the Child-Pugh classification include the progression of ascites and changes in bilirubin levels.

  1, 2, 6, and 12 months after the treatment.

• Changes of portal vein thrombosis

  6 and 12 months after the treatment.

• Liver cancer

  Up to 12 months after the treatment.

• Liver transplantation

  Up to 12 months after the treatment.

Study Arms (2)

TIPS treatment group

The patient underwent Transjugular Intrahepatic Portosystemic Shunt (TIPS) after admission

Endoscopic treatment group

The patient only received endoscopic treatment after admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• RenJi Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Shanghai East Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator
• Second Military Medical University: collaborator
• The General Hospital of Northern Theater Command: collaborator

MeSH Terms

Conditions

Hypertension, Portal; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 31, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share