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

NCT00401895 | Terminated Phase 2

• 1 other identifier: ROMTIPSRCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis

Keywords

TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT; Covered stents; portal hypertension; hepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

• hepatic encephalopathy incidence:

  1 year

Secondary Outcomes (6)

• incidence of persistent hepatic encephalopathy: defined as the presence of a continuous mental state alteration, with episodes of further worsening episodes;

  one year

• incidence of recurrent hepatic encephalopathy: defined as the onset of at least three episodes of open hepatic encephalopathy in a six-month period;

  one year

• 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;

  one year

• shunt dysfunction: defined as the finding of a portosystemic gradient higher than 12 mm Hg and angiographic evidence of shunt stenosis or occlusion;

  one year

• recurrence of ascites: defined as the need of performing at least one evacuation of ascitic fluid with paracentesis;

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

patients treated with 10 mm stent

Device: TIPS created with 8 or 10 mm covered stent

2

ACTIVE COMPARATOR

patients treated with 8 mm stent

Device: TIPS created with 8 or 10 mm covered stent

Interventions

TIPS created with 8 or 10 mm covered stent DEVICE

creation of a shunt between hepatic vein and portal vein with PTFE-covered stents

Also known as: Viatorr Goretex

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Gastroenterology Unit. dip. Medicina Clinica Policlinico Umberto I

Roma, 00100, Italy

Location

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Oliviero Riggio, MD

  Gastroenterology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

IT (1)