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

Overview of attention for article published in BMC Gastroenterology, June 2020
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Title
A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study
Published in
BMC Gastroenterology, June 2020
DOI 10.1186/s12876-020-01325-9
Pubmed ID
Authors

Christopher Lawrence, Jose Nieto, Willis G. Parsons, André Roy, Nalini M. Guda, Stephen E. Steinberg, Muhammad K. Hasan, Juan Carlos Bucobo, Satish Nagula, Nicholas D. Dey, Jonathan M. Buscaglia

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 patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths. This newly designed and marketed biliary SEMS system appears to be effective at relieving biliary obstruction and preventing re-intervention within 6 months of insertion in the overwhelming majority of patients. The device has an excellent safety profile, and associated high technical success rate during deployment. The study was registered on clinicaltrials.gov on 14 October 2013 and the study registration number is NCT01962168. University of Massachusetts Medical School did not participate in the study.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 22 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 3 14%
Other 2 9%
Student > Ph. D. Student 1 5%
Student > Bachelor 1 5%
Researcher 1 5%
Other 1 5%
Unknown 13 59%
Readers by discipline Count As %
Medicine and Dentistry 5 23%
Nursing and Health Professions 3 14%
Environmental Science 1 5%
Unknown 13 59%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 June 2020.
All research outputs
#20,622,845
of 23,213,531 outputs
Outputs from BMC Gastroenterology
#1,391
of 1,783 outputs
Outputs of similar age
#341,258
of 399,052 outputs
Outputs of similar age from BMC Gastroenterology
#39
of 50 outputs
Altmetric has tracked 23,213,531 research outputs across all sources so far. This one is in the 1st percentile – i.e., 1% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,783 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.1. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
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