Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

Currently, patients with acute bleeding of esophageal varices are treated with
local band ligation and/or sclerosing of the bleeding vessel under endoscopic
guidance. An alternative treatment is creation of a Transjugular Intrahepatic
Porto-systemic Shunt (TIPS) with a Gore-tex covered stent-graft. This is a
radiographically-guided, minimally invasive procedure that not only staunches
the bleeding, but also treats the underlying cause, increased blood pressure in
the portal vein. In this prospective clinical trial, we seek to compare these
two treatment options with regard to efficacy and cost-effectiveness.

The aim of this study is to compare the new (covered) TIPS stent with the
standard treatment, local band ligation and/or sclerosing of the bleeding
vessel under endoscopic guidance, in patients with acute bleeding of esophageal
varices, with regard to efficacy and cost-effectiveness. The theory is that
using the TIPS not only staunches the bleeding but also treats the underlying
cause, increased blood pressure in the portal vein. Therefore the risk of
rebleeding decreases. On the contrary endoscopy staunches the bleeding, but
does not treat the underlying cause. Therefore there is a high risk of
rebleeding.

In total 124 patients, divided over 3 hospitals in the Netherlands, will take
part in the study. The study is started from the Erasmus Medical Center in
Rotterdam. Furthermore patients from the Academical Medical Center in Amsterdam
and the Leiden University Medical Center will participate.
To determine whether one treatment option is better than the other, stratified
randomisation is used. The participants will be randomized into two groups,
taking into acount the Child Pugh Classification (a scoring system of liver
disease severity). Whether TIPS is more effective than the common used therapy,
local band ligation and/or sclerosing of the bleeding vessel under endoscopic
guidance, can be discovered by comparing the groups.
The participants will have the routinely controls for patients with bleeding
varicose veins. Within the scope of the study they will be followed for one
year.
The study will continue for 2 years, one year in which patients will be asked
to participate, and one year to follow the last participants.

TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure:

Through a vein in the neck, a small tube (stent) is placed between two veins in
the liver to decompress the veins of the liver.

TIPS-procedure:
TIPS will be performed under general anesthesia. Nausea and vomiting after
waking are less frequent with the current medication techniques, but might
occur. During the first hours after anesthesia some problems concerning memory
or concentration might arise.
Because of intubating ( to ensure the respiration during the
intervention)dental damage by the tube could arise. Unforeseen complications,
which are life threatening, like a grave allergy, cardiac arrest, or
respiration arrest are very rare, and they occur in less than 3 out of 10.000
anesthesias. The stent will be placed between the veins in the liver through a
vein in the neck. The place in the neck where this is done might get a bruise
after the intervention. Some days after the intervention pain from the veins
may be perceived. This will disappear spontaneously. Other complications that
might occur after the TIPS-procedure, are temporal cardiac arrhythmias,
jaundice and fever. In rare cases puncture of the liver capsule with the needle
can occur and blood might flow into the abdominal cavity, but usely this has no
major consequences.
TIPS increases the risk of hepatic encephalopathy. This is confusion and
dullness related to the liver disease. When this happens it might be neccesary
to close the stent, to decline the disturbances. Within the scope of
TIPS-procedure patients will be hopitalized standardly; this will take some
days.

Participation in the study means that the patient will be followed for one year
in view of the study. This will be done by the regular controls which are usual
for patients with esophageal varices. At month 3, 6, 9 and 12 the patient will
get a questionnaire and blood will be taken.

Burden and risks of conventional therapy (local band ligation and/or sclerosing
of the bleeding vessel under endoscopic guidance):
During the year patient will undergo this treatment again, every time he
rebleeds. For the initial stabilization and the first endoscopic treatment
patients will be hospitalized standardly. The follow-up endoscopic treatment
will be take place out patients.