Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial
We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. Randomized trials have shown similar efficacy of endoscopi...
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| Veröffentlicht in: | Annals of surgery 2023-05, Vol.277 (5), p.e1072-e1080 |
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| creator | Dayyeh, Barham K Abu Chandrasekhara, Vinay Shah, Raj J Easler, Jeffrey J Storm, Andrew C Topazian, Mark Levy, Michael J Martin, John A Petersen, Bret T Takahashi, Naoki Edmundowicz, Steven Hammad, Hazem Wagh, Mihir S Wani, Sachin DeWitt, John Bick, Benjamin Gromski, Mark Al Haddad, Mohammad Sherman, Stuart Merchant, Ambreen A Peetermans, Joyce A Gjata, Ornela McMullen, Edmund Willingham, Field F |
| description | We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.
Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.
We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.
Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.
Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808. |
| doi_str_mv | 10.1097/SLA.0000000000005274 |
| format | Article |
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Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.
We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.
Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.
Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.</description><identifier>ISSN: 0003-4932</identifier><identifier>EISSN: 1528-1140</identifier><identifier>DOI: 10.1097/SLA.0000000000005274</identifier><identifier>PMID: 35129503</identifier><language>eng</language><publisher>United States</publisher><subject>Drainage - methods ; Endosonography ; Humans ; Metals ; Necrosis - etiology ; Necrosis - surgery ; Pancreatitis, Acute Necrotizing - diagnostic imaging ; Pancreatitis, Acute Necrotizing - surgery ; Prospective Studies ; Retrospective Studies ; Stents - adverse effects ; Treatment Outcome</subject><ispartof>Annals of surgery, 2023-05, Vol.277 (5), p.e1072-e1080</ispartof><rights>Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c256t-554209c28c0635112addcc5d1959bd52c3cb527d3cf15f15a1b7aadc3de9abcc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27931,27932</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35129503$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dayyeh, Barham K Abu</creatorcontrib><creatorcontrib>Chandrasekhara, Vinay</creatorcontrib><creatorcontrib>Shah, Raj J</creatorcontrib><creatorcontrib>Easler, Jeffrey J</creatorcontrib><creatorcontrib>Storm, Andrew C</creatorcontrib><creatorcontrib>Topazian, Mark</creatorcontrib><creatorcontrib>Levy, Michael J</creatorcontrib><creatorcontrib>Martin, John A</creatorcontrib><creatorcontrib>Petersen, Bret T</creatorcontrib><creatorcontrib>Takahashi, Naoki</creatorcontrib><creatorcontrib>Edmundowicz, Steven</creatorcontrib><creatorcontrib>Hammad, Hazem</creatorcontrib><creatorcontrib>Wagh, Mihir S</creatorcontrib><creatorcontrib>Wani, Sachin</creatorcontrib><creatorcontrib>DeWitt, John</creatorcontrib><creatorcontrib>Bick, Benjamin</creatorcontrib><creatorcontrib>Gromski, Mark</creatorcontrib><creatorcontrib>Al Haddad, Mohammad</creatorcontrib><creatorcontrib>Sherman, Stuart</creatorcontrib><creatorcontrib>Merchant, Ambreen A</creatorcontrib><creatorcontrib>Peetermans, Joyce A</creatorcontrib><creatorcontrib>Gjata, Ornela</creatorcontrib><creatorcontrib>McMullen, Edmund</creatorcontrib><creatorcontrib>Willingham, Field F</creatorcontrib><title>Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial</title><title>Annals of surgery</title><addtitle>Ann Surg</addtitle><description>We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.
Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.
We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.
Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.
Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.</description><subject>Drainage - methods</subject><subject>Endosonography</subject><subject>Humans</subject><subject>Metals</subject><subject>Necrosis - etiology</subject><subject>Necrosis - surgery</subject><subject>Pancreatitis, Acute Necrotizing - diagnostic imaging</subject><subject>Pancreatitis, Acute Necrotizing - surgery</subject><subject>Prospective Studies</subject><subject>Retrospective Studies</subject><subject>Stents - adverse effects</subject><subject>Treatment Outcome</subject><issn>0003-4932</issn><issn>1528-1140</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdUdtO3DAQtaqiskD_oEJ-5CXUl3h307fV0kKl5SKxVR-jyXiyGCVxaidV4Wv4VLxiQajjkSyNz0Xjw9gXKU6lKGZfb1eLU_GujJrlH9hEGjXPpMzFRzZJU53lhVb77CDGeyFkPhezT2xfG6kKI_SEPS19W7mOLD8L4DrYEIfO8pvgB4--cY_p5Yow-Eg4-PaBr--CHzd3HPjSwz8HDV-NLXUZ9L2PrtvwSxrS8HagbuC1D_wGOgwEg0P-G5qGbObreqfp4je-2JrFPsm7v8QvxyYhE5cCX4ckf8T2amgifd7dh-zXj-_r5UW2uj7_uVysMlRmOmTG5EoUqOYopmk7qcBaRGNlYYrKGoUaq_RDVmMtTWqQ1QzAorZUQIWoD9nJi24f_J-R4lC2LiI1DXTkx1iqaTpa6FwlaP4C3a4QA9VlH1wL4aGUotxmU6Zsyv-zSbTjncNYtWTfSK9h6GcJ9Y0P</recordid><startdate>20230501</startdate><enddate>20230501</enddate><creator>Dayyeh, Barham K Abu</creator><creator>Chandrasekhara, Vinay</creator><creator>Shah, Raj J</creator><creator>Easler, Jeffrey J</creator><creator>Storm, Andrew C</creator><creator>Topazian, Mark</creator><creator>Levy, Michael J</creator><creator>Martin, John A</creator><creator>Petersen, Bret T</creator><creator>Takahashi, Naoki</creator><creator>Edmundowicz, Steven</creator><creator>Hammad, Hazem</creator><creator>Wagh, Mihir S</creator><creator>Wani, Sachin</creator><creator>DeWitt, John</creator><creator>Bick, Benjamin</creator><creator>Gromski, Mark</creator><creator>Al Haddad, Mohammad</creator><creator>Sherman, Stuart</creator><creator>Merchant, Ambreen A</creator><creator>Peetermans, Joyce A</creator><creator>Gjata, Ornela</creator><creator>McMullen, Edmund</creator><creator>Willingham, Field F</creator><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>20230501</creationdate><title>Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial</title><author>Dayyeh, Barham K Abu ; Chandrasekhara, Vinay ; Shah, Raj J ; Easler, Jeffrey J ; Storm, Andrew C ; Topazian, Mark ; Levy, Michael J ; Martin, John A ; Petersen, Bret T ; Takahashi, Naoki ; Edmundowicz, Steven ; Hammad, Hazem ; Wagh, Mihir S ; Wani, Sachin ; DeWitt, John ; Bick, Benjamin ; Gromski, Mark ; Al Haddad, Mohammad ; Sherman, Stuart ; Merchant, Ambreen A ; Peetermans, Joyce A ; Gjata, Ornela ; McMullen, Edmund ; Willingham, Field F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c256t-554209c28c0635112addcc5d1959bd52c3cb527d3cf15f15a1b7aadc3de9abcc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Drainage - methods</topic><topic>Endosonography</topic><topic>Humans</topic><topic>Metals</topic><topic>Necrosis - etiology</topic><topic>Necrosis - surgery</topic><topic>Pancreatitis, Acute Necrotizing - diagnostic imaging</topic><topic>Pancreatitis, Acute Necrotizing - surgery</topic><topic>Prospective Studies</topic><topic>Retrospective Studies</topic><topic>Stents - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dayyeh, Barham K Abu</creatorcontrib><creatorcontrib>Chandrasekhara, Vinay</creatorcontrib><creatorcontrib>Shah, Raj J</creatorcontrib><creatorcontrib>Easler, Jeffrey J</creatorcontrib><creatorcontrib>Storm, Andrew C</creatorcontrib><creatorcontrib>Topazian, Mark</creatorcontrib><creatorcontrib>Levy, Michael J</creatorcontrib><creatorcontrib>Martin, John A</creatorcontrib><creatorcontrib>Petersen, Bret T</creatorcontrib><creatorcontrib>Takahashi, Naoki</creatorcontrib><creatorcontrib>Edmundowicz, Steven</creatorcontrib><creatorcontrib>Hammad, Hazem</creatorcontrib><creatorcontrib>Wagh, Mihir S</creatorcontrib><creatorcontrib>Wani, Sachin</creatorcontrib><creatorcontrib>DeWitt, John</creatorcontrib><creatorcontrib>Bick, Benjamin</creatorcontrib><creatorcontrib>Gromski, Mark</creatorcontrib><creatorcontrib>Al Haddad, Mohammad</creatorcontrib><creatorcontrib>Sherman, Stuart</creatorcontrib><creatorcontrib>Merchant, Ambreen A</creatorcontrib><creatorcontrib>Peetermans, Joyce A</creatorcontrib><creatorcontrib>Gjata, Ornela</creatorcontrib><creatorcontrib>McMullen, Edmund</creatorcontrib><creatorcontrib>Willingham, Field F</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>Annals of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dayyeh, Barham K Abu</au><au>Chandrasekhara, Vinay</au><au>Shah, Raj J</au><au>Easler, Jeffrey J</au><au>Storm, Andrew C</au><au>Topazian, Mark</au><au>Levy, Michael J</au><au>Martin, John A</au><au>Petersen, Bret T</au><au>Takahashi, Naoki</au><au>Edmundowicz, Steven</au><au>Hammad, Hazem</au><au>Wagh, Mihir S</au><au>Wani, Sachin</au><au>DeWitt, John</au><au>Bick, Benjamin</au><au>Gromski, Mark</au><au>Al Haddad, Mohammad</au><au>Sherman, Stuart</au><au>Merchant, Ambreen A</au><au>Peetermans, Joyce A</au><au>Gjata, Ornela</au><au>McMullen, Edmund</au><au>Willingham, Field F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial</atitle><jtitle>Annals of surgery</jtitle><addtitle>Ann Surg</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>277</volume><issue>5</issue><spage>e1072</spage><epage>e1080</epage><pages>e1072-e1080</pages><issn>0003-4932</issn><eissn>1528-1140</eissn><abstract>We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.
Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.
We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.
Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.
Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.</abstract><cop>United States</cop><pmid>35129503</pmid><doi>10.1097/SLA.0000000000005274</doi></addata></record> |
| fulltext | fulltext |
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| ispartof | Annals of surgery, 2023-05, Vol.277 (5), p.e1072-e1080 |
| issn | 0003-4932 1528-1140 |
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| source | MEDLINE; Journals@Ovid Complete; PubMed Central |
| subjects | Drainage - methods Endosonography Humans Metals Necrosis - etiology Necrosis - surgery Pancreatitis, Acute Necrotizing - diagnostic imaging Pancreatitis, Acute Necrotizing - surgery Prospective Studies Retrospective Studies Stents - adverse effects Treatment Outcome |
| title | Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial |
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