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
Hauptverfasser: 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
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container_issue 5
container_start_page e1072
container_title Annals of surgery
container_volume 277
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.
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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 &gt;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. 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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 &gt;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. 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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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