Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents

This study has been terminated.
(An interim analysis revealed a significantly higher persistence/recurrence of complications of portal hypertension in the 8 mm-stent group.)
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00401895
First received: November 17, 2006
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective portal pressure reduction (essential in the treatment of those pathologies in which TIPS is indicated) still do not exist.

Aim of the study The purpose of our study is to compare the clinical efficacy and the incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with hepatic cirrhosis.


Condition Intervention Phase
Cirrhosis
Device: TIPS created with 8 or 10 mm covered stent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents in Cirrhotic Patients: A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • hepatic encephalopathy incidence: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of persistent hepatic encephalopathy: defined as the presence of a continuous mental state alteration, with episodes of further worsening episodes; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • incidence of recurrent hepatic encephalopathy: defined as the onset of at least three episodes of open hepatic encephalopathy in a six-month period; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • incidence of variceal rebleeding: defined as the finding, at esophagogastroduodenoscopy, of ongoing or recent variceal hemorrhage or the finding of blood in the stomach and the presence of varices as the only potential cause of bleeding; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • shunt dysfunction: defined as the finding of a portosystemic gradient higher than 12 mm Hg and angiographic evidence of shunt stenosis or occlusion; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • recurrence of ascites: defined as the need of performing at least one evacuation of ascitic fluid with paracentesis; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • survival: all deaths of any cause will be recorded. All mortalities occurring within a six-week period from a digestive bleeding episode will be considered as related to the bleeding itself. All deaths occurring within 30 days post-TIPS placement will [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
patients treated with 10 mm stent
Device: TIPS created with 8 or 10 mm covered stent
creation of a shunt between hepatic vein and portal vein with PTFE-covered stents
Other Name: Viatorr Goretex
Active Comparator: 2
patients treated with 8 mm stent
Device: TIPS created with 8 or 10 mm covered stent
creation of a shunt between hepatic vein and portal vein with PTFE-covered stents
Other Name: Viatorr Goretex

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive cirrhotic patients who have undergone TIPS at our Department for bleeding of esophagogastric varices refractory to medical or endoscopic treatment or for ascites/hydrothorax refractory to diuretic therapy will be considered eligible for the study.

Exclusion Criteria:

  • an age >75 years; past or present history of hepatic encephalopathy;
  • a Z-score at trial making test-A (TMT-A) >1.5;
  • bilirubine levels >5 mg/dl;
  • creatinine levels >3 mg/dl;
  • serious cardiac or pulmonary dysfunction;
  • a Child-Pugh's score >11;
  • a model end-stage liver disease (MELD) score >18;
  • portal thrombosis;
  • a diagnosis of hepatic carcinoma;
  • sepsis;
  • spontaneous bacterial peritonitis;
  • renal insufficiency.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401895

Locations
Italy
Gastroenterology Unit. dip. Medicina Clinica Policlinico Umberto I
Roma, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Oliviero Riggio, MD Gastroenterology Unit
  More Information

No publications provided

Responsible Party: Riggio Oliviero, Department of Clinical Medicine Sapienza University of Rome
ClinicalTrials.gov Identifier: NCT00401895     History of Changes
Other Study ID Numbers: ROMTIPSRCT
Study First Received: November 17, 2006
Last Updated: January 8, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT
Covered stents
portal hypertension
hepatic encephalopathy

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014