Transjugular intrahepatic portosystemic shunts compared with endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage. A randomized, controlled trial.
BACKGROUND
Transjugular intrahepatic portosystemic shunts (TIPS) have widened the use of portal decompression as therapy for variceal hemorrhage. However, no controlled studies have examined the efficacy of TIPS compared with that of other treatments.


OBJECTIVE
To compare the efficacy and safety of TIPS with those of endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage.


METHODS
Randomized, controlled trial.


METHODS
Tertiary-care academic medical center.


METHODS
100 patients with cirrhosis were evaluated a mean of approximately 10 days after an episode of acute variceal bleeding; 20 patients were excluded because of portal venous thrombosis (n = 6), hepatoma (n = 3), florid alcoholic hepatitis (n = 6), and refusal to give consent (n = 5).


METHODS
TIPS (n = 41) or sclerotherapy (n = 39). The latter was performed by freehand injections of 5% Na morrhuate at 2- to 3-week intervals. Recurrent variceal hemorrhage was managed by sclerotherapy followed by angiographic assessment of TIPS and dilatation of the stents (TIPS group) or crossover to TIPS (sclerotherapy group).


METHODS
Rebleeding and survival were the primary end points. Complications and rates of rehospitalization were secondary end points.


RESULTS
During a mean follow-up of approximately 1000 days, recurrent gastrointestinal bleeding resulted from variceal hemorrhage (9 patients in the TIPS group and 8 in the sclerotherapy group), portal gastropathy (1 patient in each group), and gastric lipoma (0 and 1 patients, respectively). A higher mortality rate was seen with TIPS (P = 0.03). Death resulted from variceal bleeding (5 patients in the TIPS group and 3 in the sclerotherapy group), sepsis (3 and 2 patients, respectively), liver failure (2 patients in each group), hepatoma (1 and 0 patients, respectively), and hemoperitoneum (1 and 0 patients, respectively). Encephalopathy was the most common complication in the TIPS group (n = 12), and pain developing after sclerotherapy was the most common in the sclerotherapy group (n = 10). The two groups had similar rates of rehospitalization.


CONCLUSIONS
Endoscopic sclerotherapy and TIPS are equivalent with respect to rebleeding developing over the long term. However, sclerotherapy may be superior to TIPS with respect to survival.
Sanyal
A J
AJ
Medical College of Virginia, Richmond, USA.
Freedman
A M
AM
Luketic
V A
VA
Purdum
P P
PP
Shiffman
M L
ML
Cole
P E
PE
Tisnado
J
J
Simmons
S
S
D000328:Adult; D002423:Cause of Death; D004724:Endoscopy; D004932:Esophageal and Gastric Varices / Q000150:complications*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019168:Portasystemic Shunt, Transjugular Intrahepatic; D012008:Recurrence; D012307:Risk Factors; D015911:Sclerotherapy; D016896:Treatment Outcome