Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study.
OBJECTIVE
Limited data are available regarding fully covered metal stents in the management of malignant distal biliary strictures. The aim of this study was to evaluate the safety of a fully covered self-expanding metal stent (FCSEMS) with flared ends, in treating malignant biliary strictures. We report our long-term retrospective analysis from 6 centers.


METHODS
A total of 260 patients (142 males, median age 68 y) underwent endoscopic retrograde cholangiopancreatography with placement of FCSEMS (WallFlex; Boston Scientific, Natick, MA) for the palliation of obstructive jaundice in the setting of pancreatic adenocarcinoma (169), metastatic disease (36), cholangiocarcinoma (23), ampullary cancer (19), or other (13). Patients were evaluated clinically in follow-up and biochemical tests of liver function were obtained. Data were recorded for the following variables: patient survival, duration of stent patency, the need for subsequent biliary intervention, and complications.


RESULTS
A total of 266 FCSEMS were placed in 260 patients. There was a median survival of 100 days (range, 7 to 531 d). There was a mean follow-up of 134±118 days (range, 4 to 519 d). Biliary decompression was successful in 252 patients (97%). At the end of the study period, 121 were alive with a patent stent, 65 patients died with a patent stent, 40 patients were successfully bridged to surgery, 8 patients had their patent stent removed and had no need for further stenting, and 18 patients were lost to follow-up. Five patients who had a successfully placed FCSEMS were considered a failure due to the following reason: migration (2), cholangitis (1), stent occlusion (1), and removal for management of proximal biliary obstruction (1). Two additional patients experienced migration that did not require FCSEMS removal or replacement. Stent replacement was required in 10 patients, of whom 6 had a second FCSEMS placed. The remaining 4 were in the failure group and underwent replacement with either uncovered stents or plastic stents. Other complications, managed conservatively, included pain (2), postendoscopic retrograde cholangiopancreatography pancreatitis (4), fever (1), retroperitoneal perforation (1), and postsphincterotomy bleeding (1). The mean patency duration was 328 days (SE 19.04). The patency percentage was 83% at 3 months, 63% at 6 months, and 48.5% at 12 months.


CONCLUSIONS
In the management of malignant distal biliary strictures, the fully covered WallFlex stent has acceptable patency and complication rates. Further long-term prospective data are required to confirm this observation.
*Division of Gastroenterology and Hepatology, Weill Cornell Medical College §Gastroenterology, Columbia University Medical Center, New York, NY †Digestive Health, University of Virginia, Charlottesville, VA ‡Gastroenterology, Thomas Jefferson University, Philadelphia, PA ∥Gastroenterology, Digestive Associates of Houston ¶Gastroenterology, Baylor Medical Center, Houston #Gastroenterology, University of Texas Health Sciences Center, San Antonio, TX.
Michel
M
Kahaleh
Jayant P
JP
Talreja
David E
DE
Loren
Thomas E
TE
Kowalski
John M
JM
Poneros
Marisa
M
Degaetani
Isaac
I
Raijman
Divyesh V
DV
Sejpal
Sandeep
S
Patel
Lauren
L
Rosenkranz
Kevin N
KN
McNamara
Alan
A
Brijbassie
Andrew Y
AY
Wang
Monica
M
Gaidhane
Amrita
A
Sethi
Peter D
PD
Stevens
D000368:Aged; D001650:Bile Duct Neoplasms / Q000150:complications* / Q000473:pathology; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D002779:Cholestasis / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D041781:Jaundice, Obstructive / Q000209:etiology / Q000628:therapy*; D008111:Liver Function Tests; D008297:Male; D008670:Metals; D010166:Palliative Care / Q000379:methods; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D008670:Metals