Status and phase
Conditions
Treatments
About
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.
Full description
Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents in Cirrhotic Patients:
A Randomized Controlled Study
Introduction In the treatment of esophageal varices rebleeding1 and ascites/hydrothorax refractory to the diuretic therapy2 by transjugular intrahepatic portosystemic shunt (TIPS), shunt stenosis (occurring in 30-70% of cases during the first post-procedural year) and the onset of hepatic encephalopathy (30-55% of cases at one year) represent two major problems.
Since the year 2000, a new polytetrafluoroethylene covered stent has highly improved TIPS patency, thus inducing a remarkable reduction of rebleeding incidence. Some authors, however, suggest that the maintenance of the shunt patency may involve an increased risk of hepatic encephalopathy, although the data in the present literature are limited and controversial. The only randomized controlled study3 available, in fact, reports a lower incidence of hepatic encephalopathy in those patients treated with covered stents as compared with those treated with conventional metallic stents. In our preliminary experience,4 instead, a similar incidence of hepatic encephalopathy was noted in both groups. In addition, in the group of patients treated by covered stents, a higher number of cases with persistent and intractable hepatic encephalopathy (requiring shunt reduction) was recorded.5 Post-TIPS hepatic encephalopathy incidence increases with the decrease of post-procedure portal pressure which depends on the caliber of the stent used to create the anastomosis. This might suggest the use of covered stents with a smaller diameter aimed at reducing the risk of hepatic encephalopathy. 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.
Methods 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.
Before the TIPS procedure, all the patients will undergo a complete clinical evaluation (including psychometric tests) to assess their past or present history of hepatic encephalopathy; their Child-Pugh and MELD scores will be determined; abdominal ultrasounds and esophagogastroduodenoscopies will be also carried out. The patients will be then randomized into two groups to undergo TIPS with either 8- or 10-mm covered stents (VIATORR®, W. L. Gore & Associates Inc., Flagstaff, AZ). The two groups will be followed up according to the same post-TIPS protocol:
The following study end-points are defined:
Sample size The sample size will be calculated on the main study end-point: the incidence of hepatic encephalopathy. On the basis of previous studies, the post-TIPS incidence of hepatic encephalopathy is considered to be of 50% at one year. To obtain a clinically significant (from 50 to 25%) encephalopathy incidence reduction (a = 5% and b= 20%) it will be therefore necessary to enroll 57 patients per group. Randomization will be by sealed envelopes in blocks of ten.
Statistical analysis The comparability of the two groups treated with 8- or 10-mm covered stents will be verified by c2 o Student t-test. The incidence of hepatic encephalopathy (main study end-point), shunt dysfunction, rebleeding, recurrence of ascites, and mortality (secondary end-points) will be calculated by Kaplan-Meier method and compared by Log-rank test. The Number Cruncher Statistical System (NCSS) software will be employed.
The rules and guidelines of the "Good Clinical Practice" and all legal requirements on sensitive data storage and experimental protocols will be followed.
References
Scand J Gastroenterol 2003;38:570-2.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
44 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal