The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03825848
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of stent patency, the incidence of rebleeding and survival in the left and right branches of the portal vein were compared.

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension; Hepatic Encephalopathy	Procedure: trans jugular intrahepatic portal systemic shunt	N/A

Detailed Description

The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent studies [14] found that implantation of 8 mm diameter is compared with the use of 10 mm diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS without affecting the shunt effect. To further evaluate the effect of "left/right branch of shunt portal" on hepatic encephalopathy after TIPS, we intend to conduct the following studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial study with Child classification, hope to guide TIPS in line with China's national conditions through the high-level evidence-based medical evidence obtained.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial
• Actual Study Start Date: Jun 20, 2019
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left Portal Vein Branch Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt	Procedure: trans jugular intrahepatic portal systemic shunt; Shunting left or right PV branch in the TIPS procedure
Experimental: Right Portal Vein Branch Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt	Procedure: trans jugular intrahepatic portal systemic shunt; Shunting left or right PV branch in the TIPS procedure

Outcome Measures

Primary Outcome Measures

1. The incidence of HE [2 years]

   compare difference incidence of HE between shunting left and right portal vein branch

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;

2. Clinically diagnosed post-hepatitis B cirrhosis;

3. History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment;

4. Liver function Child A or B;

5. Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt;

6. Platelet count ≥ 50 × 109 / L;

7. Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds;

8. Serum creatinine concentration ≤115umol/L;

9. Patients and their families agree to join the clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Imaging confirms portal vein thrombosis;

2. Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt);

3. Combine any malignant tumor;

4. History of previous hepatic encephalopathy;

5. Consolidation of intractable ascites;

6. Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency;

7. Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin > 51umol / L failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant Or lactation; severe contrast allergy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Interventional Radiology, Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

• Study Chair: Jianjun Luo, doctor, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03825848
• Other Study ID Numbers: B2018-292R
• First Posted: Jan 31, 2019
• Last Update Posted: Aug 9, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension, Portal; Hepatic Encephalopathy; Brain Diseases

Study Results

No Results Posted as of Aug 9, 2019