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Transjugular Intrahepatic Portosystemic Shunts Compared with Endoscopic Sclerotherapy for the Prevention of Recurrent Variceal Hemorrhage: A Randomized, Controlled Trial

Arun J. Sanyal, MD; Arthur M. Freedman, MD; Velimir A. Luketic, MD; Preston P. Purdum III, MD; Mitchell L. Shiffman, MD; Patricia E. Cole, PhD, MD; Jaime Tisnado, MD; and Sharon Simmons, RN
[+] Article and Author Information

From Medical College of Virginia, Richmond, Virginia Acknowledgment: The authors thank the nursing staff of the Clinical Research Center for its dedicated efforts. Grant Support: In part by an award from the National Institutes of Health to the Clinical Research Center at the Medical College of Virginia (RR-00065) and an award from the American College of Gastroenterology. Requests for Reprints: Arun J. Sanyal, MD, Medical College of Virginia, MCV Station 980711, 11th and Marshall Streets, Richmond, VA 23298-0711. Current Author Addresses: Dr. Sanyal: Medical College of Virginia, MCV Station 980711, 11th and Marshall Streets, Richmond, VA 23298-0711.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1997;126(11):849-857. doi:10.7326/0003-4819-126-11-199706010-00001
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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.

Design: Randomized, controlled trial.

Setting: Tertiary-care academic medical center.

Patients: 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).

Interventions: 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).

Measurements: 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.

Figures

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Figure 1.
Long-term effects of transjugular intrahepatic portosystemic shunts (TIPS) on portosystemic pressure gradients.P

The shunts produced an initial highly significant decrease in the gradient ( < 0.001). However, portal hypertension recurred in most patients; this condition was amenable to balloon dilatation. Data are the mean ±SD.

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Figure 2.
Kaplan-Meier analysis of the risk for rebleeding, plotted as the probability of remaining free of bleeding over time.

No significant differences were seen between the two groups. TIPS = transjugular intrahepatic portosystemic shunts.

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Figure 3.
Kaplan-Meier analysis of the risk for death, plotted as the probability of remaining alive over time.P

Patients in the sclerotherapy group had a definite survival advantage over those in the transjugular intrahepatic portosystemic shunts (TIPS) group ( = 0.03).

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