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NCT Number: NCT07502729

Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Esophageal Diseases Esophageal Varices Esophageal and Gastric Varices Gastric Varices Gastroesophageal Varices Hemorrhage Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. Liver cancer

    Time frame: Up to 12 months after the treatment.

    Hepatocellular carcinoma or cholangiocarcinoma

  5. Liver transplantation

    Time frame: Up to 12 months after the treatment.

    Based on comprehensive clinical evaluation, liver transplantation is required.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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