Portal HypertensionNCT06883071
Clinical Study on the Selection of Endoscopic Varicose Disconnection Strategy Based on Natural Portal Shunt with Portal Hypertension
A study testing Endoscopic ultrasound (EUS)-guided spring plug combined with ECI and Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI in people with Portal Hypertension, run by Zhejiang University.
Trial summary
Research content: This trial follows the randomized controlled study protocol to study the varicose vein elimination rate, amount of tissue glue used, rebleeding rate, complications, mortality, length of hospital stay, treatment costs, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Endoscopic ultrasound (EUS)-guided spring plug combined with ECI and Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Interventional
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
Who may be able to join
- 1. Age ≥ 18 years old; 2. History of liver cirrhosis and previous portal hypertension bleeding; 3. Endoscopic and abdominal CT evaluation of IGV1 varicose veins and the presence of SPSS; 4. The patient agrees to treatment under EUS
Who cannot join
- 1. Patients who have received treatment for portal hypertension bleeding (including endoscopy, intervention, and surgery) in the past; 2. Patients with critical illness, pregnant patients, immunodeficiency diseases (such as systemic lupus erythematosus), and mental illness; 3. Patients who refuse endoscopic treatment
About this study
Research content: This trial follows the randomized controlled study protocol to study the varicose vein elimination rate, amount of tissue glue used, rebleeding rate, complications, mortality, length of hospital stay, treatment costs, etc. of different endoscopic treatment methods for GV patients, and combines the correlation of factors such as etiology, liver function grade, and gender. So as to formulate the best treatment strategy for endoscopic treatment of GV patients.
Research objectives: By collecting case data, blood tests, gastroscopy reports, and CTP examination results of GV patients, endoscopic secondary prevention interruption surgery is performed on them. Compare the varicose vein elimination rate, amount of tissue glue used, rebleeding rate, complications, mortality, length of hospital stay, treatment costs, etc. of GV patients after endoscopic treatment, and evaluate the efficacy of different endoscopic treatment methods. At the same time, combined with factors such as etiology, liver function grade, and gender, formulate the best strategy for endoscopic interruption treatment of GV patients.
Read more
Key scientific issues to be addressed: a. Compare the efficacy of different endoscopic treatments for gastric varices with natural portosystemic shunts b. Provide a basis for strategic selection for endoscopic devascularization of gastric varices 5. Research methods, technical routes and schedule Research methods
- Clinical trial registration All patients complied with the Declaration of Helsinki, and the study was reviewed and approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine.
- Patient inclusion and related examinations 32 patients with GV were included, with the following inclusion criteria: 1. Age ≥ 18 years; 2. History of liver cirrhosis and previous portal hypertension bleeding; 3. Endoscopic and abdominal CT assessment of IGV1 varicose veins and presence of SPSS; 4. Patients agreed to EUS treatment Exclusion criteria: 1. Previous treatment for portal hypertension bleeding (including endoscopy, intervention, and surgery); 2. Patients with critical illness, pregnant patients, immunodeficiency diseases (such as systemic lupus erythematosus), and mental illness; 3. Patients who refused endoscopic treatment
- Implementation of the plan: All patients with complete hemodynamic characteristics of gastric varicose veins and stable vital signs were treated with endoscopic interruption of flow and signed a consent form for treatment; all patients were randomly divided into 2 groups (random table established), with 16 patients in each group. Group A: endoscopic ultrasound (EUS)-guided spring plug combined with ECI: Spring plug was placed to limit flow in varicose veins determined by EUS, and then tissue glue was injected under EUS to block varicose veins. Group B: Titanium clip plus EUS-guided spring plug flow limiting combined with ECI: After partial endoscopic titanium clip flow limiting, spring coils were placed in the varicose veins under ultrasound (EUS) guidance to determine the inflow and outflow tracts and to inject woven glue. Patients in both groups underwent CTP and gastroscopy follow-up at 1 month, 3 months, and 6 months after the initial treatment, and additional endoscopic treatment was performed if necessary; if bleeding occurred again during the period, timely treatment was given according to the condition (drugs, endoscopy, intervention or surgery); if other complications occurred, if they did not affect the study, the planned plan was continued.
- Comparative analysis of results:
The postoperative bleeding rate of patients in the two groups after gastroscopy diagnosis and treatment was observed and compared (including a. short-term bleeding rate within 72 hours: hematemesis or black stool; systolic blood pressure decreased by >20 mmHg or heart rate increased by >20 times/min; in the absence of blood transfusion: hemoglobin decreased by >30 g/L; b. rebleeding: active bleeding occurred within 6 months; differences in hospitalization time and cost, as well as gender, age, etiology, basic liver function, etc. were further compared.)
- Conditions
- Portal Hypertension
- Being tested
- Endoscopic ultrasound (EUS)-guided spring plug combined with ECI, Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound (EUS)-guided spring plug combined with ECIProcedure or surgery
Group A: Spring plug combined with ECI under the guidance of endoscopic ultrasound (EUS): Spring plug was placed to limit the flow of varicose veins by EUS, and then tissue glue was injected under EUS to block the varicose veins. Group B: Titanium clip plus EUS-guided spring plug placement to limit the flow combined with ECI: After partial titanium clip flow limitation under endoscopy, spring coil combined with tissue glue injection was placed in the varicose veins by judging the inflow and outflow tracts under the guidance of ultrasound (EUS).
Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECIProcedure or surgery
Group A: Spring plug combined with ECI under the guidance of endoscopic ultrasound (EUS): Spring plug was placed to limit the flow of varicose veins by EUS, and then tissue glue was injected under EUS to block the varicose veins. Group B: Titanium clip plus EUS-guided spring plug placement to limit the flow combined with ECI: After partial titanium clip flow limitation under endoscopy, spring coil combined with tissue glue injection was placed in the varicose veins by judging the inflow and outflow tracts under the guidance of ultrasound (EUS).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Procedure: Endoscopic ultrasound (EUS)-guided spring plug combined with ECI |
| Group B | Active comparator | Not described Receives: Procedure: Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation and comparison of bleeding rates after gastroscopy in two groups
The bleeding rates after gastroscopy diagnosis and treatment were observed and compared between the two groups (including a. short-term bleeding rate within 72 hours: hematemesis or melena; systolic blood pressure decreased by >20 mmHg or heart rate increased by >20 times/min; in the absence of blood transfusion: hemoglobin decreased by >30 g/L; b. rebleeding: active bleeding within 6 months; differences in hospitalization time and cost, as well as gender, age, etiology, basic liver function, etc. were further compared).
Measured: Gastroscopy follow-up was performed 1 month, 3 months, and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Xiaolong Zheng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883071
- Sponsor's protocol ID
- YAN2024-0545
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes