Esophageal VaricesNCT06970509
Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
An observational study of Esophageal Varices and Portal Hypertension, run by Shanghai Zhongshan Hospital at 10 sites in China.
Trial summary
Endoscopic esophageal variceal ligation combined with gastric variceal embolization using tissue glue is currently the first-choice method for preventing rebleeding in patients with cirrhosis and portal hypertension. However, the rebleeding rate remains relatively high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices, Portal Hypertension
- How many people
- 1,450 participants
- Where
- 10 sitesChina
- Study dates
- 1 Mar 2025to Dec 2032
- 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: The data for the training group and internal validation group were derived from patients with portal hypertension and esophagogastric varices who visited Fudan University Zhongshan Hospital from January 1, 2019, to December 31, 2024. The enrolled patients were randomly divided into the training group and internal validation group at a ratio of 3:1. The external validation group was sourced from patients with portal hypertension and esophagogastric varices who visited participating institutions from January 1, 2019, to December 31, 2024.
Who may be able to join
- Confirmed diagnosis of portal hypertension;
- Underwent imaging and endoscopic examination or treatment within one week after admission;
- Endoscopy revealed the presence of esophageal and/or gastric varices.
Who cannot join
- CT image slice thickness does not meet the requirements or there are artifacts;
- Endoscopy shows no presence of esophageal and/or gastric varices;
- Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems;
- Lack of important historical medical information or other relevant data.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
+86-021-65641990, ec@zs-hospital.sh.cn
- Recruiting
People's Liberation Army Northern Theater General Hospital
Shenyang, Liaoning
About this study
Official title: Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension: Novel Strategies for Diagnosis, Treatment and Prognostic Assessment System of Cirrhotic Portal Hypertension
Endoscopic esophageal variceal ligation combined with gastric variceal embolization using tissue glue is currently the first-choice method for preventing rebleeding in patients with cirrhosis and portal hypertension. However, the rebleeding rate remains relatively high. Factors such as extra-luminal vascular bundles in the esophagus and stomach walls, and portosystemic shunts significantly affect the therapeutic outcomes. Therefore, there is an urgent need to develop an individualized treatment model for esophagogastric varices based on the anatomical and hemodynamic characteristics of the varices, to stratify patient risks and provide tailored treatment options.
Before the treatment of esophagogastric varices, the vascular characteristics of esophagogastric varices are assessed based on imaging data such as portal venous CT and ultrasound, as well as clinical information. Risk factors influencing bleeding from esophagogastric varices are explored, and an endoscopic and interventional variceal stratification and treatment model is constructed to provide patients with personalized options for endoscopic or interventional therapy.
Read more
During the treatment of esophagogastric varices, precise endovascular embolization of the source branch vessels of esophagogastric varices is performed based on hemodynamic models. The safety and efficacy of this treatment strategy are verified through randomized controlled clinical trials.
After the treatment of esophagogastric varices, the feasibility of reducing the risk of rebleeding in patients with poor endoscopic outcomes is examined by using drugs that lower portal venous pressure, such as carvedilol or novel oral anticoagulants. Factors influencing recompensation and reversal of portal hypertension are also clarified.
- Conditions
- Esophageal Varices, Portal Hypertension
- Keywords
- Endoscopic Treatment
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal
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 |
|---|---|---|
| Esophagogastric Variceal Characterization Model for Portal Hypertension Patients | We have previously preliminarily constructed an automatic segmentation model for intra- and extra-luminal esophageal vessels. This model was validated in the portal venous CT scans of 52 patients with cirrhosis and esophagogastric varices, yielding Dice, Jaccard, 95HD, and ASD scores of 0.903, 0.841, 5.428, and 0.959, respectively, indicating good segmentation performance of the model. To meet the requirements for feature extraction, modeling, and machine learning based on omics characteristics, at least 450 patients are needed. Based on the patient admission situation at our center, we plan to enroll 250 patients in the training set for modeling and 100 patients in the internal validation set, following a 2.5:1 allocation ratio. Other research centers are expected to enroll 100 patients as the external validation group. | |
| Endoscopic and Pharmacological Therapy Prognostic Prediction Model | Taking anticoagulant use as an example, the incidence of portal vein thrombosis (PVT) in patients with portal hypertension is approximately 10-25%. The use of anticoagulant drugs can significantly improve the recanalization of portal vein thrombosis (hazard ratio = 1.3) and improve patient prognosis. With a 1:1 ratio of the two groups, a significance level of 0.05, and a power of 0.9, and following up for 180 days on events such as thrombus recanalization and rupture bleeding of esophageal and gastric varices, the sample size calculation formula for a two-sided test indicates that each group requires 448 cases. Considering a 10% dropout rate, 500 patients will be included in the personalized treatment group for varices and 500 in the traditional treatment group, totaling 1000 patients. Among them, our hospital plans to complete 700 cases, and the multicenter units will complete 300 cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal bleeding
Gastrointestinal bleeding within 1 year
Measured: 1 year
Secondary outcomes (2)
Gastrointestinal bleeding
Gastrointestinal bleeding within 6 months, 3 years, and 5 years
Measured: 6 months, 3 years, and 5 years
The occurrence of clinical events
The occurrence of events such as ascites progression, overt jaundice, changes in portal vein thrombosis, hepatocellular carcinoma, liver transplantation, or survival and death within 6 months, 1 year, 3 years, and 5 years.
Measured: 6 months, 1 year, 3 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiyao Chen, Ph.D., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970509
- Sponsor's protocol ID
- B2025-180R
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. 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: Novel Strategies for Diagnosis, Treatment and Prognostic Assessment System of Cirrhotic Portal Hypertension
- ClinicalTrials.gov ID
- NCT06970509
- Acronym / sponsor ID
- B2025-180R
- Conditions
- Esophageal Varices, Portal Hypertension
- Keywords
- Endoscopic Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 May 2025 (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.
Endoscopic esophageal variceal ligation combined with gastric variceal embolization using tissue glue is currently the first-choice method for preventing rebleeding in patients with cirrhosis and portal hypertension. However, the rebleeding rate remains relatively high. Factors such as extra-luminal vascular bundles in the esophagus and stomach walls, and portosystemic shunts significantly affect the therapeutic outcomes. Therefore, there is an urgent need to develop an individualized treatment model for esophagogastric varices based on the anatomical and hemodynamic characteristics of the varices, to stratify patient risks and provide tailored treatment options.
Before the treatment of esophagogastric varices, the vascular characteristics of esophagogastric varices are assessed based on imaging data such as portal venous CT and ultrasound, as well as clinical information. Risk factors influencing bleeding from esophagogastric varices are explored, and an endoscopic and interventional variceal stratification and treatment model is constructed to provide patients with personalized options for endoscopic or interventional therapy.
During the treatment of esophagogastric varices, precise endovascular embolization of the source branch vessels of esophagogastric varices is performed based on hemodynamic models. The safety and efficacy of this treatment strategy are verified through randomized controlled clinical trials.
After the treatment of esophagogastric varices, the feasibility of reducing the risk of rebleeding in patients with poor endoscopic outcomes is examined by using drugs that lower portal venous pressure, such as carvedilol or novel oral anticoagulants. Factors influencing recompensation and reversal of portal hypertension are also clarified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophagogastric Variceal Characterization Model for Portal Hypertension Patients | – | –We have previously preliminarily constructed an automatic segmentation model for intra- and extra-luminal esophageal vessels. This model was validated in the portal venous CT scans of 52 patients with cirrhosis and esophagogastric varices, yielding Dice, Jaccard, 95HD, and ASD scores of 0.903, 0.841, 5.428, and 0.959, respectively, indicating good segmentation performance of the model. To meet the requirements for feature extraction, modeling, and machine learning based on omics characteristics, at least 450 patients are needed. Based on the patient admission situation at our center, we plan to enroll 250 patients in the training set for modeling and 100 patients in the internal validation set, following a 2.5:1 allocation ratio. Other research centers are expected to enroll 100 patients as the external validation group. |
| Endoscopic and Pharmacological Therapy Prognostic Prediction Model | – | –Taking anticoagulant use as an example, the incidence of portal vein thrombosis (PVT) in patients with portal hypertension is approximately 10-25%. The use of anticoagulant drugs can significantly improve the recanalization of portal vein thrombosis (hazard ratio = 1.3) and improve patient prognosis. With a 1:1 ratio of the two groups, a significance level of 0.05, and a power of 0.9, and following up for 180 days on events such as thrombus recanalization and rupture bleeding of esophageal and gastric varices, the sample size calculation formula for a two-sided test indicates that each group requires 448 cases. Considering a 10% dropout rate, 500 patients will be included in the personalized treatment group for varices and 500 in the traditional treatment group, totaling 1000 patients. Among them, our hospital plans to complete 700 cases, and the multicenter units will complete 300 cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data for the training group and internal validation group were derived from patients with portal hypertension and esophagogastric varices who visited Fudan University Zhongshan Hospital from January 1, 2019, to December 31, 2024. The enrolled patients were randomly divided into the training group and internal validation group at a ratio of 3:1. The external validation group was sourced from patients with portal hypertension and esophagogastric varices who visited participating institutions from January 1, 2019, to December 31, 2024.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of portal hypertension;
- Underwent imaging and endoscopic examination or treatment within one week after admission;
- Endoscopy revealed the presence of esophageal and/or gastric varices.
Key exclusion criteria (4 listed)
- CT image slice thickness does not meet the requirements or there are artifacts;
- Endoscopy shows no presence of esophageal and/or gastric varices;
- Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems;
- Lack of important historical medical information or other relevant data.
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
Gastrointestinal bleeding
Time frame: 1 year
Gastrointestinal bleeding within 1 year
2 secondary outcomes
Gastrointestinal bleeding
Time frame: 6 months, 3 years, and 5 years
The occurrence of clinical events
Time frame: 6 months, 1 year, 3 years, and 5 years
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 14 May 2025.
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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.
Shiyao Chen, Ph.D. principal investigator
Shanghai Zhongshan Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices and Portal Hypertension, run by Shanghai Zhongshan Hospital at 10 sites in China.
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 3 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Yiting Wang, Ph.D. (+86-15221919860, wang.yiting@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal bleeding (time frame: 1 year). 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 14 May 2025.