TY - JOUR
T1 - Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis
T2 - A Prospective Multicenter Trial
AU - Dayyeh, Barham K.Abu
AU - Chandrasekhara, Vinay
AU - Shah, Raj J.
AU - Easler, Jeffrey J.
AU - Storm, Andrew C.
AU - Topazian, Mark
AU - Levy, Michael J.
AU - Martin, John A.
AU - Petersen, Bret T.
AU - Takahashi, Naoki
AU - Edmundowicz, Steven
AU - Hammad, Hazem
AU - Wagh, Mihir S.
AU - Wani, Sachin
AU - Dewitt, John
AU - Bick, Benjamin
AU - Gromski, Mark
AU - Al Haddad, Mohammad
AU - Sherman, Stuart
AU - Merchant, Ambreen A.
AU - Peetermans, Joyce A.
AU - Gjata, Ornela
AU - McMullen, Edmund
AU - Willingham, Field F.
N1 - Publisher Copyright:
© 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - Objective: 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. Summary Background Data: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. Design: 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 a≤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 â 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. Results: 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 ±curren; 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. Conclusions: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe.
AB - Objective: 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. Summary Background Data: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. Design: 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 a≤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 â 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. Results: 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 ±curren; 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. Conclusions: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe.
KW - drainage
KW - metal stents
KW - pancreatic fluid collection
KW - pancreatitis
KW - plastic stents
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UR - http://www.scopus.com/inward/citedby.url?scp=85152260945&partnerID=8YFLogxK
U2 - 10.1097/SLA.0000000000005274
DO - 10.1097/SLA.0000000000005274
M3 - Article
C2 - 35129503
AN - SCOPUS:85152260945
SN - 0003-4932
VL - 277
SP - E1072-E1080
JO - Annals of surgery
JF - Annals of surgery
IS - 5
ER -