Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

Abstract

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 ≥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.

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 ± 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. Clinicaltrials.-gov no: NCT03525808.

• Authors: Barham K Abu Dayyeh, Vinay Chandrasekhara, Raj J Shah, Jeffrey J Easler, Andrew C Storm, Mark Topazian, Michael J Levy, John A Martin, Bret T Petersen, Naoki Takahashi, Steven Edmundowicz, Hazem Hammad, Mihir S Wagh, Sachin Wani, John DeWitt, Benjamin Bick, Mark Gromski, Mohammad Al Haddad, Stuart Sherman, Ambreen A Merchant, Joyce A Peetermans, Ornela Gjata, Edmund McMullen, Field F Willingham
• Journal: Annals of surgery (Ann Surg) Vol. 277 Issue 5 Pg. e1072-e1080 (05 01 2023) ISSN: 1528-1140 [Electronic] United States
• PMID: 35129503 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Metals

Topics

• Humans
• Drainage (methods)
• Endosonography
• Metals
• Necrosis (etiology, surgery)
• Pancreatitis, Acute Necrotizing (diagnostic imaging, surgery)
• Prospective Studies
• Retrospective Studies
• Stents (adverse effects)
• Treatment Outcome