A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)

Background Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for...

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Veröffentlicht in:Gastrointestinal endoscopy 2015-07, Vol.82 (1), p.70-78
Hauptverfasser: Canena, Jorge, MD, PhD, Liberato, Manuel, MD, Meireles, Liliane, MD, Marques, Inês, MD, Romão, Carlos, MD, Coutinho, António Pereira, MD, Neves, Beatriz Costa, MD, Veiga, Pedro Mota, BSc
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container_end_page 78
container_issue 1
container_start_page 70
container_title Gastrointestinal endoscopy
container_volume 82
creator Canena, Jorge, MD, PhD
Liberato, Manuel, MD
Meireles, Liliane, MD
Marques, Inês, MD
Romão, Carlos, MD
Coutinho, António Pereira, MD
Neves, Beatriz Costa, MD
Veiga, Pedro Mota, BSc
description Background Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. Objective To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Design Prospective study. Setting Two tertiary-care referral academic centers and one general district hospital. Patients Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Interventions Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Main Outcome Measurements Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Results Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs ( P  = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ2 [1] = 8.30; P  < .01) in favor of the FCSEMS group. Use of 
doi_str_mv 10.1016/j.gie.2014.11.038
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However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. Objective To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Design Prospective study. Setting Two tertiary-care referral academic centers and one general district hospital. Patients Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Interventions Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Main Outcome Measurements Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Results Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs ( P  = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ2 [1] = 8.30; P  &lt; .01) in favor of the FCSEMS group. Use of &lt;3 plastic stents ( P  = .024), a plastic stent diameter &lt;20F ( P  = .006), and a high-grade biliary leak ( P  = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Limitations Non-randomized design. Conclusion In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations.</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2014.11.038</identifier><identifier>PMID: 25771064</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biliary Tract Diseases - etiology ; Biliary Tract Diseases - therapy ; Cholangiopancreatography, Endoscopic Retrograde ; Cholecystectomy ; Female ; Follow-Up Studies ; Gastroenterology and Hepatology ; Humans ; Intention to Treat Analysis ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Postoperative Complications - therapy ; Prospective Studies ; Self Expandable Metallic Stents ; Stents ; Treatment Outcome</subject><ispartof>Gastrointestinal endoscopy, 2015-07, Vol.82 (1), p.70-78</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2015 American Society for Gastrointestinal Endoscopy</rights><rights>Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-689db5a597879543dcb9f97063759842f85ba3dbfa33bd991cd3db40e5fef1303</citedby><cites>FETCH-LOGICAL-c451t-689db5a597879543dcb9f97063759842f85ba3dbfa33bd991cd3db40e5fef1303</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.gie.2014.11.038$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3549,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25771064$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Canena, Jorge, MD, PhD</creatorcontrib><creatorcontrib>Liberato, Manuel, MD</creatorcontrib><creatorcontrib>Meireles, Liliane, MD</creatorcontrib><creatorcontrib>Marques, Inês, MD</creatorcontrib><creatorcontrib>Romão, Carlos, MD</creatorcontrib><creatorcontrib>Coutinho, António Pereira, MD</creatorcontrib><creatorcontrib>Neves, Beatriz Costa, MD</creatorcontrib><creatorcontrib>Veiga, Pedro Mota, BSc</creatorcontrib><title>A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)</title><title>Gastrointestinal endoscopy</title><addtitle>Gastrointest Endosc</addtitle><description>Background Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. Objective To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Design Prospective study. Setting Two tertiary-care referral academic centers and one general district hospital. Patients Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Interventions Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Main Outcome Measurements Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Results Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs ( P  = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ2 [1] = 8.30; P  &lt; .01) in favor of the FCSEMS group. Use of &lt;3 plastic stents ( P  = .024), a plastic stent diameter &lt;20F ( P  = .006), and a high-grade biliary leak ( P  = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Limitations Non-randomized design. Conclusion In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biliary Tract Diseases - etiology</subject><subject>Biliary Tract Diseases - therapy</subject><subject>Cholangiopancreatography, Endoscopic Retrograde</subject><subject>Cholecystectomy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gastroenterology and Hepatology</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Postoperative Complications - therapy</subject><subject>Prospective Studies</subject><subject>Self Expandable Metallic Stents</subject><subject>Stents</subject><subject>Treatment Outcome</subject><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ks1u1DAQxyMEokvhAbggH8shwY6TTSwkpKqigFSJA3C2HHvS9daJg-1sCc_bB2HSbTlw4ORE-n-M5-cse81owSjbvtsX1xaKkrKqYKygvH2SbRgVTb5tGvE021AU5TWjzUn2IsY9pbQtOXuenZR10zC6rTbZ3TkZ_ZgHNRo_2N9gSEyzWYgdifZjBD0newAyqWRhTJHc2rQjk49J77wDvcQEOvlhIQH6oPAzLKSzzio8HagbdOw8uYUAZFCjusYCwKqo_WS1cm45JqYdkDkC8T0ZZpfs5LDTqZisxoHum30g_bwatD9gHA4Krs_h14Sjqw71AyTlHtVn97EHa8DHty-zZ71yEV49nKfZj8uP3y8-51dfP325OL_KdVWzlG9bYbpa1aJpG1FX3OhO9KKhW97Uoq3Kvq07xU3XK847IwTTBv8qCnUPPeOUn2Znx9wp-J8zxCQHGzU4p0bwc5QMGzhtWVWjlB2lOvgYcXlyCnbArUlG5QpX7iXClStcyZhEuOh58xA_dwOYv45Hmih4fxQAXvJgIcioEZsGYwNiksbb_8Z_-MetnR1XSjewQNz7OYy4PclkLCWV39bXtT4uVtGyEpTyP0nX0VM</recordid><startdate>20150701</startdate><enddate>20150701</enddate><creator>Canena, Jorge, MD, PhD</creator><creator>Liberato, Manuel, MD</creator><creator>Meireles, Liliane, MD</creator><creator>Marques, Inês, MD</creator><creator>Romão, Carlos, MD</creator><creator>Coutinho, António Pereira, MD</creator><creator>Neves, Beatriz Costa, MD</creator><creator>Veiga, Pedro Mota, BSc</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20150701</creationdate><title>A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)</title><author>Canena, Jorge, MD, PhD ; Liberato, Manuel, MD ; Meireles, Liliane, MD ; Marques, Inês, MD ; Romão, Carlos, MD ; Coutinho, António Pereira, MD ; Neves, Beatriz Costa, MD ; Veiga, Pedro Mota, BSc</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-689db5a597879543dcb9f97063759842f85ba3dbfa33bd991cd3db40e5fef1303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biliary Tract Diseases - etiology</topic><topic>Biliary Tract Diseases - therapy</topic><topic>Cholangiopancreatography, Endoscopic Retrograde</topic><topic>Cholecystectomy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gastroenterology and Hepatology</topic><topic>Humans</topic><topic>Intention to Treat Analysis</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Postoperative Complications - therapy</topic><topic>Prospective Studies</topic><topic>Self Expandable Metallic Stents</topic><topic>Stents</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Canena, Jorge, MD, PhD</creatorcontrib><creatorcontrib>Liberato, Manuel, MD</creatorcontrib><creatorcontrib>Meireles, Liliane, MD</creatorcontrib><creatorcontrib>Marques, Inês, MD</creatorcontrib><creatorcontrib>Romão, Carlos, MD</creatorcontrib><creatorcontrib>Coutinho, António Pereira, MD</creatorcontrib><creatorcontrib>Neves, Beatriz Costa, MD</creatorcontrib><creatorcontrib>Veiga, Pedro Mota, BSc</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Canena, Jorge, MD, PhD</au><au>Liberato, Manuel, MD</au><au>Meireles, Liliane, MD</au><au>Marques, Inês, MD</au><au>Romão, Carlos, MD</au><au>Coutinho, António Pereira, MD</au><au>Neves, Beatriz Costa, MD</au><au>Veiga, Pedro Mota, BSc</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2015-07-01</date><risdate>2015</risdate><volume>82</volume><issue>1</issue><spage>70</spage><epage>78</epage><pages>70-78</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><abstract>Background Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. Objective To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Design Prospective study. Setting Two tertiary-care referral academic centers and one general district hospital. Patients Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Interventions Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Main Outcome Measurements Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Results Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs ( P  = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ2 [1] = 8.30; P  &lt; .01) in favor of the FCSEMS group. Use of &lt;3 plastic stents ( P  = .024), a plastic stent diameter &lt;20F ( P  = .006), and a high-grade biliary leak ( P  = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Limitations Non-randomized design. Conclusion In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25771064</pmid><doi>10.1016/j.gie.2014.11.038</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Biliary Tract Diseases - etiology
Biliary Tract Diseases - therapy
Cholangiopancreatography, Endoscopic Retrograde
Cholecystectomy
Female
Follow-Up Studies
Gastroenterology and Hepatology
Humans
Intention to Treat Analysis
Kaplan-Meier Estimate
Male
Middle Aged
Postoperative Complications - therapy
Prospective Studies
Self Expandable Metallic Stents
Stents
Treatment Outcome
title A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)
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