Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis

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.

Repetitive endoscopic drainage as initial intervention is safe and effective for early treatment of pancreatic necrotic collections

“…5 A recent study recommended protocolised use of endoscopic necrosectomy, but it did not consider potential complications. 9 In fact, the only colonic fistula in our study was a complication of endoscopic necrosectomy and its invasiveness may also limit its use in ANC due to lack of mature capsule.…”

“…7,8 Based on endoscopic step-up approach, protocolised endoscopic necrosectomy after primary drainage has been reported. 9 European guidelines recommended delaying the first intervention of PNC for 4 weeks, which was only supported by weak evidence. 3 Multiple cohort studies have investigated this issue but have conflicting results.…”

“…Endoscopic drainage was also found to have shorter LOS but required more re‐intervention in comparison to laparoscopic drainage 7,8 . Based on endoscopic step‐up approach, protocolised endoscopic necrosectomy after primary drainage has been reported 9 …”

Time to think prime times for treatment of necrotizing pancreatitis: Pendulum conundrum

“…CT and magnetic resonance imaging with cholangiopancreatography [MRCP]) after initial EUS-guided drainage of PFCs (Table 2). 8,[32][33][34][35][36][37][38] CT is primarily used as follow-up imaging, but its timing varies significantly from 72 h to 8 weeks. The follow-up images are performed for two purposes: confirmation of PFC response/resolution and evaluation of disconnected pancreatic duct syndrome (DPDS).…”

“…Furthermore, AP is a risk factor for pancreatic cancer, which remains high as long as 10 years after AP. 57,58 Thus, it might be difficult to stop surveillance of pancreatic cancer 33 US or CT Repeated at 2-4 weeks Bang, 2019 34 CT and ERCP 6 weeks postintervention; ERCP to assess for pancreatic duct integrity Abu Dayyeh, 2021 35 CT or MRI Initially at 7 days, and 14 days after drainage and after each intervention Maharshi, 2021 36 US 3 weeks after drainage Siddiqui, 2021 37 Contrast-enhanced CT or US 4-8 weeks after stent placement Chavan, 2022 38 MRI with MRCP 4 weeks before removal of stents Bang, 2022 8 CT 72 h postintervention as initial evaluation CT, computed tomography; ERCP, endoscopic retrograde cholangiopancreatography; MRCP, magnetic resonance cholangiopancreatography; MRI, magnetic resonance imaging; US, ultrasonography. or pancreatic function deficiency at this moment, and we need to define high-risk patients who need long-term followup.…”