Endoscopic necrosectomy of infected WON in acute necrotising pancreatitis - Development of an effective therapeutic algorithm based on a single-center consecutive patient cohort.

OBJECTIVE: Development of an effective therapeutic algorithm for interventional (minimally invasive) approach to infected walled-off necrosis (WON) in patients with necrotising pancreatitis reflecting real-word data. MATERIAL/METHODS: All consecutive patients who underwent endoscopic necrosectomy for necrotising pancreatitis through a defined study period were enclosed in this retrospective observational case study. The therapeutic approach was analysed for clinical success rate, complication spectrum and rate as well as mortality and compared with data from the literature. Finally, a therapeutic algorithm was derived. RESULTS: From 2004 to 2019, 126 patients with necrotising pancreatitis (median of APACHE II score, 10.5 points) were treated. In 92.9 % of cases (n=117), an infected WON with microbial pathogen detection was found. After a median of 18 days from symptom onset, first intervention was performed (53.2 % as percutaneous drainage with programmed rinsing, 29.4 % as EUS-guided internal drainage). From 2004 to 2010, double pigtail stents were used. Later, lumen-apposing metal stent (LAMS) such as AXIOSTM stent (Boston Scientific, Ratingen, Germany) was preferred. The combined percutaneous and internal drainage was performed in approximately 50 % of subjects.Endoscopic transluminal necrosectomy was performed in 123 patients (97.6 %) at a median of 33 days from symptom onset. Endoscopic percutaneous necrosectomy was conducted in 11.1 % of the individuals. A median number of two endoscopic necrosectomy sessions per patient was necessary for the therapy. The clinical success rate (discharge without surgical intervention) was 82.5 %. The complication rate (bleeding and perforation) and the need for surgery were both 9.5 %. The overall mortality was 8.7 %. CONCLUSION: Therapy of necrotising pancreatitis with infected WON consists of early calculated antibiotic therapy with adequate drainage. Combined external and internal drainages with programmed rinsing seem to improve prognosis, as well as minimise I) : the need for forced necrosectomies (mainly via a transluminal access site) and II) : complication rate as well as, thus, improve outcome.

EUS-guided biliary interventions for benign diseases and unsuccessful ERCP - a prospective unicenter feasibility study on a large consecutive patient cohort.

BACKGROUND AND STUDY AIM: Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for the treatment of biliary obstruction of any etiology. However, cannulation failure of the common bile duct (CBD) by ERCP occurs in 5-10%. Alternatives after a failed ERCP are re-ERCP by an expert endoscopist, percutaneous transhepatic cholangio drainage (PTCD), (balloon) enteroscopy-assisted ERCP, or surgery. Endoscopic ultrasonography-guided drainage of the bile ducts (EUS-BD) is becoming the standard of care in tertiary referral centers for cases of failed ERCP in patients with malignant obstruction of the CBD. In expert hands, EUS-guided biliary drainage has excellent technical/clinical success rates and lower complication rates compared to PTCD. Despite the successful performance of EUS-BD in malignant cases, its use in benign cases is limited. The aim of this study (design, systematic prospective clinical observational study on quality assurance in daily clinical practice) was to evaluate the efficacy and safety of EUS-BD in benign indications. PATIENTS AND METHODS: Patients with cholestasis and failed ERCP were recruited from a prospective EUS-BD registry (2004-2020). One hundred and three patients with EUS-BD and benign cholestasis were extracted from the registry (nTotal = 474). Indications of EUS-BDs included surgically altered anatomy (n = 65), atypical bile duct percutaneous transhepatic cholangio orifice at the duodenal junction from the longitudinal to the horizontal segment (n = 1), papilla of Vater not reached due to the gastric outlet/duodenal stenoses (n = 6), papilla that cannot be catheterized (n = 24), and proximal bile duct stenosis (n = 7). The primary endpoint was technical and clinical success. Secondary endpoints were procedure-related complications during the hospital stay. RESULTS: 103 patients with EUS-BD and benign cholestasis were extracted from the registry (nTotal=474). Different transluminal access routes were used to reach the bile ducts: transgastric (n = 72/103); -duodenal (n = 16/103); -jejunal (n = 14/103); combined -duodenal and -gastric (n = 1/103). The technical success rate was 96 % (n = 99) for cholangiography. Drainage was not required in 2 patients; balloon dilatation including stone extraction was sufficient in 17 cases (16.5 %; no additional or prophylactic insertion of a drain). Transluminal drainage was achieved in n = 68/103 (66 %; even higher in patients with drain indication only) by placement of a plastic stent (n = 29), conventional biliary metal stents (n = 24), HotAXIOS stents (n = 5; Boston Scientific, Ratingen, Germany), Hanaro stents (n = 6; Olympus, Hamburg, Germany), HotAXIOS stents and plastic stents (n = 1), HotAXIOS stents and metal stents (n = 1) and metal stents and plastic stents (n = 2). Techniques for stone extraction alone (nSuccessful=17) or stent insertion (nTotal = 85; nSuccessful=85 - rate, 100 %) and final EUS-BD access pathway included: Rendezvous technique (n = 14/85; 16.5 %), antegrade internal drainage (n = 20/85; 23.5 %), choledochointestinostomy (n = 7/85; 8.2 %), antegrade internal and hepaticointestinostomy (n = 22/85; 25.9 %), hepaticointestinostomy (n = 21/85; 24.7 %), choledochointestinostomy and hepaticointestinostomy (n = 1/85; 1.2 %).The complication rate was 25 % (n = 26) - the spectrum comprised stent dislocation (n = 11), perforation (n = 1), pain (n = 2), hemorrhage (n = 6), biliary ascites/leakage (n = 3) and bilioma/liver abscess (n = 3; major complication rate, n = 12/68 - 17.6 %). Re-interventions were required in 19 patients (24 interventions in total). DISCUSSION: EUS-BD can be considered an elegant and safe alternative to PTCD or reoperation for failed ERCP to achieve the necessary drainage of the biliary system even in underlying benign diseases. An interventional EUS-based internal procedure can resolve cholestasis, avoid PTCD or reoperation, and thus improve quality of life. Due to the often complex (pathological and/or postoperative) anatomy, EUS-BD should only be performed in centers with interventional endoscopy/EUS experience including adequate abdominal surgery and interventional radiology expertise in the background. This enables adequately adapted therapeutic management in the event of challenging complications. It seems appropriate to conduct further studies with larger numbers of cases to systematize the approach and peri-interventional management and to successively develop specific equipment.