A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study.

BMC Gastroenterology
Christopher LawrenceStudy Investigators

Abstract

Biliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction. This post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring re-intervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment. SEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight pat...Continue Reading

Associated Clinical Trials

References

May 27, 2011·Endoscopy·J-M DumonceauUNKNOWN European Society of Gastrointestinal Endoscopy
Jan 22, 2013·Clinics and Research in Hepatology and Gastroenterology·Wan-dong HongXiang-rong Chen
Feb 16, 2013·Gastrointestinal Endoscopy·Patrick R PfauSarah A Rodriguez
Apr 2, 2013·Gastrointestinal Endoscopy Clinics of North America·Kevin Webb, Michael Saunders
May 3, 2013·Digestive Endoscopy : Official Journal of the Japan Gastroenterological Endoscopy Society·Takao ItoiKentaro Ishii

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Methods Mentioned

BETA
sedation

Clinical Trials Mentioned

NCT01962168

Software Mentioned

Statistical Analysis Software ( SAS

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