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Not yet recruitingNCT07502729Updated Mar 31, 2026

Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

An observational study in Portal Hypertension, Gastroesophageal Varices Hemorrhage and Gastric Varices, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Shanghai Zhongshan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,066
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Portal Hypertension
  • Gastroesophageal Varices Hemorrhage
  • Gastric Varices
  • Esophageal Varices
03

In context

Hypertension, Portal

332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.

This study's planned enrollment of 1,066 is above the median of 152 across 119 observational studies indexed under Hypertension, Portal.

Browse Hypertension, Portal studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,066 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • TIPS treatment group

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

  • Endoscopic treatment group

    The patient only received endoscopic treatment after admission.

06

What researchers measure

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 treatment

  2. 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.

  5. Liver transplantation

    Based on comprehensive clinical evaluation, liver transplantation is required.

    Time frame: Up to 12 months after the treatment.

  6. 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.

  7. 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07502729
Lead sponsor
Shanghai Zhongshan Hospital
Collaborators
RenJi Hospital, Shandong Provincial Hospital, Qilu Hospital of Shandong University, Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Nanchang University, Shanghai East Hospital, Shanghai Changzheng Hospital, Second Military Medical University, The General Hospital of Northern Theater Command
Responsible party
Shiyao Chen (Professor, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Mar 31, 2026
Start date
Mar 17, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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