Comparison of Covered and Bare Stent in TIPS

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Device: covered stent; Device: bare stent

• Registration Number: NCT02540382
• Lead Sponsor: Beijing Shijitan Hospital, Capital Medical University

Brief Summary

Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.

Detailed Description

From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-08-27
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-03
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

1. portal hypertension patients with defined indications for TIPS treatment;
2. scheduled for elective TIPS; and
3. aged between 18-70 years.

Exclusion Criteria

1. combined with hepatic encephalopathy before the treatment;
2. combined with portal vein thrombosis;
3. combined with malignant liver tumor or malignancies at the other sites; or
4. combined with hemorrhage of gastrointestinal ulcer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
covered stent	covered stent	Procedure/Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm covered stents (Bard, Fluency). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No.
bare stent	bare stent	Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm bare stents (EV3, protégé; Cordis, Smart). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No.

Primary Outcome Measures

Name	Time	Method
restenosis/occlusion rate	up to 5 years	The cumulative restenosis rate in 1, 2, 3, 4, or 5-year

Secondary Outcome Measures

Name	Time	Method
recurrence rate of gastrointestinal bleeding	up to 5 years
survival rate	up to 5 years	The 1, 2, 3, 4 and 5-year survival rate
rate of secondary interventional therapy	up to 5 years	rate of secondary interventional therapy
recurrence rate of refractory hydrothorax/ascites	up to 5 years	the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up
incidence rate of hepatic encephalopathy	up to 5 years	The incidence rate of hepatic encephalopathy

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China