Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

N/ANot Yet RecruitingNCT07502729

Shanghai Zhongshan Hospital1,066 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,066

Conditions

Portal Hypertension Gastroesophageal Varices Hemorrhage Gastric Varices Esophageal Varices

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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 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.

Time frame: 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.

Time frame: 6 and 12 months after the treatment.

Liver cancer

Hepatocellular carcinoma or cholangiocarcinoma

Time frame: Up to 12 months after the treatment.

Liver transplantation

Based on comprehensive clinical evaluation, liver transplantation is required.

Time frame: 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.

Time frame: 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.

Time frame: Up to 12 months after the treatment.