Comparison of Covered and Bare Stent in TIPS

Beijing Shijitan Hospital, Capital Medical University

Status: Completed

Conditions: Cirrhosis

Treatments: Device: bare stent; Device: covered stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02540382

liufq_sjt

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 2 patient groups

covered stent

Experimental group

Description:

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.

Treatment:

Device: covered stent

bare stent

Other group

Description:

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.

Treatment:

Device: bare stent