Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,066 Participants
are grouped into 2 trial groupsGroup A: TIPS treatment group
Group B: Endoscopic treatment group
Trial outcomes
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)
Time frame
1 year after the treatment.Secondary outcomes
1
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)
Time frame
2 months and 6 months after the treatment2
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.
Time frame
1, 2, 6, and 12 months after the treatment.3
Changes of portal vein thrombosis
Evaluate the occurrence, recanalization, and other changes in thrombosis every 6 months using portal CTA and ultrasound.
Time frame
6 and 12 months after the treatment.4
Liver cancer
Hepatocellular carcinoma or cholangiocarcinoma
Time frame
Up to 12 months after the treatment.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: