Multicenter Trial Evaluating the Use of Covered... : Journal of Clinical Gastroenterology (original) (raw)

LIVER, PANCREAS AND BILIARY TRACT: Original Articles

Multicenter Trial Evaluating the Use of Covered Self-expanding Metal Stents in Benign Biliary Strictures

Time to Revisit Our Therapeutic Options?

Kahaleh, Michel MD, FASGE*; Brijbassie, Alan MD†; Sethi, Amrita MD‡; DeGaetani, Marisa MD‡; Poneros, John M. MD‡; Loren, David E. MD§; Kowalski, Thomas E. MD§; Sejpal, Divyesh V. MD∥; Patel, Sandeep MD¶; Rosenkranz, Laura MD¶; McNamara, Kevin N. MD¶; Raijman, Isaac MD#; Talreja, Jayant P. MD†; Gaidhane, Monica MD, MPH*; Sauer, Bryan G. MD†; Stevens, Peter D. MD‡

*Division of Gastroenterology and Hepatology, Weill Cornell Medical Center

‡Division of Gastroenterology and Hepatology, Columbia University Medical Center, New York, NY

†Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA

§Division of Gastroenterology, Thomas Jefferson, Philadelphia, PA

∥Gastroenterology and Hepatology, Baylor Clinic

#Gastroenterology, Digestive Associates of Houston, Houston

¶Gastroenterology, University of Texas Health Science Center, San Antonio, TX

Presented as a scientific poster at the Digestive Disease Week—Chicago in May 2011.

M.K.: study concept and design; M.K., A.S., J.P., D.L., T.K., D.S., S.P., L.R., K.M.N., I.R., M.G., B.S., P.S.: acquisition of data; M.K., A.B., A.S., M.D.G., J.P., D.L., T.K., D.S., S.P., L.R., K.M.N., I.R., J.T., M.G., B.S., P.S.: critical revision of the manuscript for important intellectual content; M.K., A.S., J.P., D.L., T.K., D.S., S.P., L.R., K.M.N., I.R., B.S., P.S.: study supervision; A.B., M.D.G., J.T.: drafting of the manuscript; M.G., B.S.: interpretation of data; M.G., B.S.: statistical analyses; M.G.: study coordination.

Peter D. Stevens, MD, passed away before submitting a signed Authorship Responsibility, Disclosure, and Copyright Transfer form. The authors declare that they have nothing to disclose.

Reprints: Michel Kahaleh, MD, FASGE, Division of Gastroenterology and Hepatology, Weill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10021 (e-mail: [email protected]).

Received June 23, 2012

Accepted November 26, 2012

Abstract

Background:

Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS.

Aim:

To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS.

Patients and Methods:

Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study.

Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications.

Results:

A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)].

Conclusions:

FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.