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Transjugular Intrahepatic Portosystemic Shunts Versus Sclerotherapy: A Discussion of Discordant Results
- Harold O. Conn, MD
- Yale University, New Haven, CT 06510 Note added in proof: After this editorial was typeset, a report by Rossle and colleagues of a randomized clinical trial comparing TIPS and endoscopic sclerotherapy was published in The Lancet [17]. This study is the largest of the four studies published on this topic so far. It differs from the others in that it compares TIPS plus embolization of esophageal varices with endoscopic sclerotherapy that used 1) polidocanol or 2) banding ligation of varices plus propanolol in a dose designed to reduce the heart rate by 25%. Revisions of the stent-shunts and repeated courses of sclerotherapy, the standard methods of applying these therapies, were performed as needed. In 14% of patients in the endoscopy group, TIPS were created when sclerotherapy was deemed unsuccessful. Requests for Reprints: Harold O. Conn, MD, 160 Morgan Avenue, East Haven, CT 06512.
“The best laid plans o' mice and men gang aft agley.”
Robert Burns
This issue presents the initial reports of two randomized, controlled trials that compared endoscopic sclerotherapy with transjugular intrahepatic portosystemic shunts (TIPS) in the treatment of patients who survived hemorrhage from esophageal varices [1, 2]. Only one previous such study has been published as a peer-reviewed article [3]. Although the goals and the experimental designs of these trials are similar, they are not identical. Furthermore, the results of the three studies are quite different.
In all three studies, endoscopic sclerotherapy, which is widely held to be the standard therapy for bleeding varices, can be considered to be the control treatment and TIPS to be the investigational treatment. All three studies demonstrate that both therapies can be instituted promptly and effectively. However, several inherent features of these two procedures prevent the performance of an ideal randomized trial. First, the two therapies are intrinsically so different that a truly double-blind randomized trial is virtually impossible. Bias and perceptions of bias cannot be completely eliminated in unblinded investigations. Second, in the temporal sense, the two procedures cannot be exactly compared. An experienced radiologist can create TIPS in an hour or so, after which the portosystemic pressure gradient is reduced by half. Endoscopic sclerotherapy for varices, however, is a much more deliberate, labor-intensive procedure. In Sanyal and colleagues' study [1], sclerotherapy was performed in 6 to 10 sessions during a period of 3 to 4 months. Thus, the sclerotherapy group endured an appreciably longer period at risk for portal hypertension than did the TIPS group. It is unlikely that the two treatments can be initiated with the same promptness in all patients, and such differences must be taken into account when the results of these studies are analyzed. Third, …
