Portal HypertensionNCT07502729
Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding
An observational study of Portal Hypertension and Gastroesophageal Varices Hemorrhage, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Gastroesophageal Varices Hemorrhage, Gastric Varices
- How many people
- 1,066 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
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
- Medical subject headings
- Hypertension, Portal, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TIPS treatment group | The patient underwent Transjugular Intrahepatic Portosystemic Shunt (TIPS) after admission | |
| Endoscopic treatment group | The patient only received endoscopic treatment after admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year after the treatment.
Secondary outcomes (7)
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)
Measured: 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.
Measured: 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.
Measured: 6 and 12 months after the treatment.
Liver cancer
Hepatocellular carcinoma or cholangiocarcinoma
Measured: Up to 12 months after the treatment.
Liver transplantation
Based on comprehensive clinical evaluation, liver transplantation is required.
Measured: 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.
Measured: 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.
Measured: Up to 12 months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start17 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,066 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502729
- Sponsor's protocol ID
- B2025-835
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
- ClinicalTrials.gov ID
- NCT07502729
- Acronym / sponsor ID
- B2025-835
- Conditions
- Portal Hypertension, Gastroesophageal Varices Hemorrhage, Gastric Varices, Esophageal Varices
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,066 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- 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
- Study start
- 17 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS treatment group | – | –The patient underwent Transjugular Intrahepatic Portosystemic Shunt (TIPS) after admission |
| Endoscopic treatment group | – | –The patient only received endoscopic treatment after admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
2-month and 6-month gastrointestinal rebleeding rates
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.
Time frame: 1, 2, 6, and 12 months after the treatment.
Changes of portal vein thrombosis
Time frame: 6 and 12 months after the treatment.
Liver cancer
Time frame: Up to 12 months after the treatment.
Liver transplantation
Time frame: Up to 12 months after the treatment.
Variceal bleeding-related mortality
Time frame: Up to 12 months after the treatment.
Liver-related mortality
Time frame: Up to 12 months after the treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Gastroesophageal Varices Hemorrhage, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year gastrointestinal rebleeding rate (time frame: 1 year after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.