Clinical Study on the Selection of Endoscopic Varicose Disconnection Strategy Based on Natural Portal Shunt with Portal Hypertension

NCT06883071 | Not Yet Recruiting DMC

• 1 other identifier: YAN2024-0545
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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

1. 1.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.
2. 2.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
3. 3.Implementation of the plan:
4. 4.Comparative analysis of results:

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• 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).

  Gastroscopy follow-up was performed 1 month, 3 months, and 6 months after treatment.

Study Arms (2)

Group A

EXPERIMENTAL

Procedure: Endoscopic ultrasound (EUS)-guided spring plug combined with ECI

Group B

ACTIVE COMPARATOR

Procedure: Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI

Interventions

Endoscopic ultrasound (EUS)-guided spring plug combined with ECI PROCEDURE

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).

Group A

Titanium clip plus EUS-guided spring plug placement for flow limiting combined with ECI PROCEDURE

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).

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Zhejiang University: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Experimental researcher

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL