التفاصيل البيبلوغرافية
| العنوان: |
A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study |
| المؤلفون: |
Lawrence, Christopher, Nieto, Jose, Parsons, Willis G., Roy, André, Guda, Nalini M., Steinberg, Stephen E., Hasan, Muhammad K., Bucobo, Juan Carlos, Nagula, Satish, Dey, Nicholas D., Buscaglia, Jonathan M. |
| المساهمون: |
Cook Research Incorporated |
| المصدر: |
BMC Gastroenterology ; volume 20, issue 1 ; ISSN 1471-230X |
| بيانات النشر: |
Springer Science and Business Media LLC |
| سنة النشر: |
2020 |
| مصطلحات موضوعية: |
Gastroenterology, General Medicine |
| الوصف: |
Background 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. Methods 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. Results 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 ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1186/s12876-020-01325-9 |
| DOI: |
10.1186/s12876-020-01325-9.pdf |
| DOI: |
10.1186/s12876-020-01325-9/fulltext.html |
| الإتاحة: |
https://doi.org/10.1186/s12876-020-01325-9Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: |
edsbas.66D528FE |
| قاعدة البيانات: |
BASE |
