Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage. A randomized, controlled trial.
BACKGROUND
Hemorrhage from esophageal varices remains a substantial management problem. Endoscopic sclerotherapy was preferred for more than a decade, but fluoroscopically placed intrahepatic portosystemic stents have recently been used with increasing frequency.


OBJECTIVE
To compare sclerotherapy with transjugular intrahepatic portosystemic shunt (TIPS) in patients with bleeding from esophageal varices.


METHODS
Randomized, controlled clinical trial.


METHODS
Three teaching hospitals.


METHODS
49 adults hospitalized with acute variceal hemorrhage from November 1991 to December 1995: 25 assigned to sclerotherapy and 24 assigned to TIPS.


METHODS
Patients assigned to repeated sclerotherapy had the procedure weekly. In those assigned to TIPS, an expandable mesh stent was fluoroscopically placed between an intrahepatic portal vein and an adjacent hepatic vein.


METHODS
Pretreatment measures included demographic and laboratory data. Postrandomization data included index hospitalization survival, duration of follow-up, successful obliteration of varices, rebleeding from varices, number of variceal rebleeding events, total days of hospitalization for variceal bleeding, blood transfusion requirements after randomization, prevalence of encephalopathy, and total health care costs.


RESULTS
Mean follow-up (+/-SE) was 567 +/- 104 days in the sclerotherapy group and 575 +/- 109 days in the TIPS group. Varices were obliterated more reliably by TIPS than by sclerotherapy (P < 0.001). Patients having TIPS were significantly less likely to rebleed from esophageal varices than patients receiving sclerotherapy (3 of 24 compared with 12 of 25; P = 0.012). No other follow-up measures differed significantly between groups. A trend toward improved survival, which was not statistically significant, was noted in the TIPS group (hazard ratio, 0.53 [95% CI, 0.18 to 1.5]).


CONCLUSIONS
In obliterating varices and reducing rebleeding events from esophageal varies, TIPS was more effective than sclerotherapy. However, TIPS did not decrease morbidity after randomization or improve health care costs. It seemed to produce better survival, but the increase in survival was not statistically significant.
Cello
J P
JP
University of California at San Francisco 94143-0628, USA.
Ring
E J
EJ
Olcott
E W
EW
Koch
J
J
Gordon
R
R
Sandhu
J
J
Morgan
D R
DR
Ostroff
J W
JW
Rockey
D C
DC
Bacchetti
P
P
LaBerge
J
J
Lake
J R
JR
Somberg
K
K
Doherty
C
C
Davila
M
M
McQuaid
K
K
Wall
S D
SD
D000328:Adult; D004724:Endoscopy; D004932:Esophageal and Gastric Varices / Q000150:complications*; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D019168:Portasystemic Shunt, Transjugular Intrahepatic; D016016:Proportional Hazards Models; D012008:Recurrence; D015911:Sclerotherapy; D016019:Survival Analysis; D016896:Treatment Outcome