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Initial performance profile of a new 6F self-expanding metal stent for palliation of malignant hilar biliary obstruction - 24/08/11

Doi : 10.1016/j.gie.2010.04.037 
Jennifer Chennat, MD , Irving Waxman, MD
Current affiliations: Center for Endoscopic Research and Therapeutics, Section of Gastroenterology, Department of Medicine, University of Chicago Medical Center, Chicago, Illinois 

Reprint requests: Jennifer Chennat, MD, Center for Endoscopic Research and Therapeutics, University of Chicago Medical Center, 5758 S. Maryland Avenue, MC 9028, Chicago, IL 60637

Riassunto

Background

A 6F endoscopic biliary self-expanding metal stent (SEMS) has been newly introduced for intended simultaneous side-by-side bilateral deployment in hilar malignant obstruction.

Objective

To report our initial experience with the Zilver 635 biliary SEMS.

Design

Retrospective chart review.

Setting

Tertiary referral medical center.

Patients

Sixteen consecutive malignant hilar biliary obstruction patients.

Interventions

Endoscopic palliative treatment of malignant biliary obstruction with the Zilver 635 SEMS from December 2008 to January 2010.

Main Outcome Measurements

Technical/functional success rates, early complications (within 30 days of stent placement), early/late stent occlusion, and biliary reintervention rates.

Results

A total of 49 Zilver SEMSs were placed in 16 patients (mean age 61 years, 6 men) for Bismuth type II (n = 4), III (n = 5), and IV (n = 7) lesions. Twelve had cholangiocarcinoma, 2 had metastatic colon cancer, 1 had lung cancer, and 1 had pancreatic cancer. The technical success rate was 100%. Side-by-side simultaneous bilateral stent deployment was required and was achieved successfully in 10 cases. Additional transpapillary stents were placed for potential future biliary access. The 30-day mortality rate was 0%. There were 1 early (6%) and 3 late (19%) stent occlusions. Successful overall biliary drainage was 75%.

Limitations

Small sample size, uncontrolled retrospective study.

Conclusions

Malignant hilar biliary obstruction endoscopic palliation with the Zilver 635 SEMS offers acceptable initial feasibility, safety, and efficacy profiles. The current design facilitates smaller bile duct negotiation and more precise intrahepatic placement. Expanding available lengths would allow transpapillary bridged bilateral SEMS placement for future reobstructed biliary access. Further long-term studies are required for comparative outcomes with other current SEMS technology.

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Abbreviations : ERC, IQR, PTBD, SEMS


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 DISCLOSURE: The following author disclosed financial relationships relevant to this publication. Dr. Waxman: Consultant for and grant support from Cook Medical Inc. The other author disclosed no financial relationships relevant to this publication.


© 2010  Pubblicato da Elsevier Masson SAS.
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Vol 72 - N° 3

P. 632-636 - settembre 2010 Ritorno al numero
Articolo precedente Articolo precedente
  • Large-diameter therapeutic channel duodenoscope to facilitate simultaneous deployment of side-by-side self-expandable metal stents in hilar cholangiocarcinoma
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