Endoscopic papillectomy for ampullary lesions of minor papilla.

BACKGROUND AND AIMS: Ampullary lesions (ALs) of the minor duodenal papilla are extremely rare. Endoscopic papillectomy (EP) is a routinely used treatment for AL of the major duodenal papilla, but the role of EP for minor AL has not been accurately studied. METHODS: We identified 20 patients with ALs of minor duodenal papilla in the multicentric database from the Endoscopic Papillectomy vs Surgical Ampullectomy vs Pancreatitcoduodenectomy for Ampullary Neoplasm study, which included 1422 EPs. We used propensity score matching (nearest-neighbor method) to match these cases with ALs of the major duodenal papilla based on age, sex, histologic subtype, and size of the lesion in a 1:2 ratio. Cohorts were compared by means of chi-square or Fisher exact test as well as Mann-Whitney U test. RESULTS: Propensity score-based matching identified a cohort of 60 (minor papilla 20, major papilla 40) patients with similar baseline characteristics. The most common histologic subtype of lesions of minor papilla was an ampullary adenoma in 12 patients (3 low-grade dysplasia and 9 high-grade dysplasia). Five patients revealed nonneoplastic lesions. Invasive cancer (T1a), adenomyoma, and neuroendocrine neoplasia were each found in 1 case. The rate of complete resection, en-bloc resection, and recurrences were similar between the groups. There were no severe adverse events after EP of lesions of minor papilla. One patient had delayed bleeding that could be treated by endoscopic hemostasis, and 2 patients showed a recurrence in surveillance endoscopy after a median follow-up of 21 months (interquartile range, 12-50 months). CONCLUSIONS: EP is safe and effective in ALs of the minor duodenal papilla. Such lesions could be managed according to guidelines for EP of major duodenal papilla.

Endoscopic and Surgical Management of Non-Metastatic Ampullary Neuroendocrine Neoplasia: A Multi-Institutional Pancreas2000/EPC Study.

INTRODUCTION: Ampullary neuroendocrine neoplasia (NEN) is rare and evidence regarding their management is scarce. This study aimed to describe clinicopathological features, management, and prognosis of ampullary NEN according to their endoscopic or surgical management. METHODS: From a multi-institutional international database, patients treated with either endoscopic papillectomy (EP), transduodenal surgical ampullectomy (TSA), or pancreaticoduodenectomy (PD) for ampullary NEN were included. Clinical features, post-procedure complications, and recurrences were assessed. RESULTS: 65 patients were included, 20 (30.8%) treated with EP, 19 (29.2%) with TSA, and 26 (40%) with PD. Patients were mostly asymptomatic (n = 46; 70.8%). Median tumor size was 17 mm (12-22), tumors were mostly grade 1 (70.8%) and pT2 (55.4%). Two (10%) EP resulted in severe American Society for Gastrointestinal Enterology (ASGE) adverse post-procedure complications and 10 (50%) were R0. Clavien 3-5 complications did not occur after TSA and in 4, including 1 postoperative death (15.4%) of patients after PD, with 17 (89.5%) and 26 R0 resection (100%), respectively. The pN1/2 rate was 51.9% (n = 14) after PD. Tumor size larger than 1 cm (i.e., pT stage >1) was a predictor for R1 resection (p < 0.001). Three-year overall survival and disease-free survival after EP, TSA, and PD were 92%, 68%, 92% and 92%, 85%, 73%, respectively. CONCLUSION: Management of ampullary NEN is challenging. EP should not be performed in lesions larger than 1 cm or with a endoscopic ultrasonography T stage beyond T1. Local resection by TSA seems safe and feasible for lesions without nodal involvement. PD should be preferred for larger ampullary NEN at risk of nodal metastasis.

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.

Endoscopic retrograde pancreatography-guided versus endoscopic ultrasound-guided technique for pancreatic duct cannulation in patients with pancreaticojejunostomy stenosis: a systematic literature review.

BACKGROUND: Stenosis of the pancreaticojejunostomy is a well-known long-term complication of pancreaticoduodenectomy. Traditionally, the endoscopic approach consisted of endoscopic retrograde pancreatography (ERP). Endoscopic ultrasound (EUS)-guided intervention has emerged as an alternative, but the success rate and adverse event rate of both treatment modalities are poorly known. We aimed to compare the outcome data of both interventions. METHODS: We performed a systematic literature search using the Pubmed/Medline and Embase databases in order to summarize the available data regarding efficacy and complications of ERP- and EUS-guided pancreatic duct (PD) drainage and compare these outcome data using uniform outcome measures in a multilevel logistic model. RESULTS : 13 studies were included, involving 77 patients who underwent ERP-guided drainage, 145 who underwent EUS-guided drainage, and 12 patients who underwent both modalities. An EUS-guided approach was significantly superior to an ERP-guided approach with regard to pancreatic duct opacification (87 % vs. 30 %; P < 0.001), cannulation success (79 % vs. 26 %; P < 0.001), and stent placement (72 % vs. 20 %; P < 0.001). An EUS-guided approach also appeared superior with regard to clinical outcomes such a pain resolution. The adverse event rate between the two treatment modalities could not be compared due to insufficient data. All included studies were found to be of low quality. CONCLUSION: Based on limited available data, EUS-guided PD intervention appears superior to ERP-guided PD intervention.

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.

Contrast-Enhanced Ultrasound Algorithms (CEUS-LIRADS/ESCULAP) for the Noninvasive Diagnosis of Hepatocellular Carcinoma - A Prospective Multicenter DEGUM Study.

BACKGROUND: This prospective multicenter study funded by the DEGUM assesses the diagnostic accuracy of standardized contrast-enhanced ultrasound (CEUS) for the noninvasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. METHODS: Patients at high risk for HCC with a histologically proven focal liver lesion on B-mode ultrasound were recruited prospectively in a multicenter approach. Clinical and imaging data were entered via online entry forms. The diagnostic accuracies for the noninvasive diagnosis of HCC were compared for the conventional interpretation of standardized CEUS at the time of the examination (= CEUS on-site) and the two CEUS algorithms ESCULAP (Erlanger Synopsis for Contrast-enhanced Ultrasound for Liver lesion Assessment in Patients at risk) and CEUS LI-RADS (Contrast-Enhanced UltraSound Liver Imaging Reporting and Data System). RESULTS: 321 patients were recruited in 43 centers; 299 (93.1 %) had liver cirrhosis. The diagnosis according to histology was HCC in 256 cases, and intrahepatic cholangiocarcinoma (iCCA) in 23 cases. In the subgroup of cirrhotic patients (n = 299), the highest sensitivity for the diagnosis of HCC was achieved with the CEUS algorithm ESCULAP (94.2 %) and CEUS on-site (90.9 %). The lowest sensitivity was reached with the CEUS LI-RADS algorithm (64 %; p < 0.001). However, the specificity of CEUS LI-RADS (78.9 %) was superior to that of ESCULAP (50.9 %) and CEUS on-site (64.9 %; p < 0.001). At the same time, the negative predictive value (NPV) of CEUS LI-RADS was significantly inferior to that of ESCULAP (34.1 % vs. 67.4 %; p < 0.001) and CEUS on-site (62.7 %; p < 0.001). The positive predictive values of all modalities were high (around 90 %), with the best results seen for CEUS LI-RADS and CEUS on-site. CONCLUSION: This is the first multicenter, prospective comparison of standardized CEUS and the recently developed CEUS-based algorithms in histologically proven liver lesions in cirrhotic patients. Our results reaffirm the excellent diagnostic accuracy of CEUS for the noninvasive diagnosis of HCC in high-risk patients. However, on-site diagnosis by an experienced examiner achieves an almost equal diagnostic accuracy compared to CEUS-based diagnostic algorithms.

[EUS-guided therapy of cholangiolithiasis in surgically altered anatomy of the upper GI tract - a unicenter case study]. / Endosonografisch gestützteTherapie der Cholangiolithiasis bei chirurgisch veränderter Anatomie ­ eine monozentrische Fallstudie.

AIM: To investigate feasibility and outcome the novel and favorable option of an endoscopic ultrasonography(EUS)-guided antegrade or even retrograde gall stone extraction via a transhepatic route in patients (pats.) with no option for the usual gold standard, ERCP. MATERIAL/METHODS: All consecutive pats. with cholangiolithiasis and surgically altered anatomy of the upper GI tract with and without previous attempts of an ERCP were enrolled in this unicenter case study and were characterized with regard to the technical and clinical success of this approach. RESULTS: From 2004 to 03/2020, overall 449 pats. underwent EUS-guided cholangiodrainage (n = 37 pats. with cholangiolithiasis). In 8 of these 37 pats., gall stone extraction was achieved using EUS-ERCP rendezvous technique (not included in the study since there was no surgically altered anatomy of the upper GI tract). In 13 of the remaining 29 subjects (45 %), there was a failure of previous attempts to reach the papilla of Vater or biliodigestive anastomosis using balloon-enteroscopy-guided ERCP. EUS-guided access to the biliary system was achieved in all 29 pats. Stone extraction was performed in 26 individuals (90 %) by means of antegrade push-technique after balloon dilatation of the papilla of Vater and biliodigestive anastomosis, respectively, before. In 11/29 cases (42 %), double pigtail prostheses were subsequently placed to track papilla of Vater/biliodigestive anastomosis ("ring drainage"), which were removed with gastroscopy three months later after previous ultrasound- and lab parameter-based follow-up control. In two pats. (7 %), gall stones were extracted via a retrograde route using a transhepatic access site; in one patient (3 %), stones were removed by means of a combined ante-/retrograde technique. In two subjects (7 %), cholangioscopy with electrohydraulic lithotripsy was used.Technical as well as clinical success rate was 100 % (29 of 29 pats.). Re-interventions became necessary in 6/29 cases (21 %), complications occurred in 6 individuals (21 %). CONCLUSION: EUS-guided stone extraction in antegrade or retrograde technique for pats. with surgically altered anatomy of the upper GI tract can be considered a favorable and safe but challenging approach of interventional endoscopy/EUS. It can provide high technical and clinical success and low complication rates; it has the potential to substitute the time-consuming balloon-enteroscopy-guided ERCP as well as, in particular, PTCD and, thus, secundary and tertiary therapeutic alternatives.

[Current Endoscopic Methods in Bariatric Surgery]. / Aktuelle endoskopische Methoden in der Adipositas- und metabolischen Chirurgie.

The 2011 World Health Summit reported the epidemics of diabetes mellitus and morbid obesity. In Germany, 62.7% of the population have a BMI above 25 kg/m² and 21.9% above 30 kg/m². 10.5 patients per 100,000 inhabitants were treated with metabolic surgery, whereas in France 86.0 and in Sweden 114.8 patients per 100,000 inhabitants were given surgery. The development of endoscopic methods leads to the opportunity to bridge patients with a high risk profile before operation. Endoscopy is an excellent procedure with few complications. However, these methods need a selective and specialised concept of treatment. Endoscopy in metabolic surgery requires expertise in both endoscopy and in the techniques of metabolic surgery. The aim of the present paper is to report the new methods of endoscopy in the treatment of obese patients, on the basis of the literature and our own experience.

Endoscopic ultrasound elastography of small solid pancreatic lesions: a multicenter study.

BACKGROUND: The prevalence of malignancy in patients with small solid pancreatic lesions is low; however, early diagnosis is crucial for successful treatment of these cases. Therefore, a method to reliably distinguish between benign and malignant small solid pancreatic lesions would be highly desirable. We investigated the role of endoscopic ultrasound (EUS) elastography in this setting. METHODS: Patients with solid pancreatic lesions ≤ 15 mm in size and a definite diagnosis were included. Lesion stiffness relative to the surrounding pancreatic parenchyma, as qualitatively assessed and documented at the time of EUS elastography, was retrospectively compared with the final diagnosis obtained by fine-needle aspiration/biopsy or surgical resection. RESULTS: 218 patients were analyzed. The average size of the lesions was 11 ± 3 mm; 23 % were ductal adenocarcinoma, 52 % neuroendocrine tumors, 8 % metastases, and 17 % other entities; 66 % of the lesions were benign. On elastography, 50 % of lesions were stiffer than the surrounding pancreatic parenchyma (stiff lesions) and 50 % were less stiff or of similar stiffness (soft lesions). High stiffness of the lesion had a sensitivity of 84 % (95 % confidence interval 73 % - 91 %), specificity of 67 % (58 % - 74 %), positive predictive value (PPV) of 56 % (50 % - 62 %), and negative predictive value (NPV) of 89 % (83 % - 93 %) for the diagnosis of malignancy. For the diagnosis of pancreatic ductal adenocarcinoma, the sensitivity, specificity, PPV, and NPV were 96 % (87 % - 100 %), 64 % (56 % - 71 %), 45 % (40 % - 50 %), and 98 % (93 % - 100 %), respectively. CONCLUSIONS: In patients with small solid pancreatic lesions, EUS elastography can rule out malignancy with a high level of certainty if the lesion appears soft. A stiff lesion can be either benign or malignant.

Similar Efficacies of Endoscopic Ultrasound Gallbladder Drainage With a Lumen-Apposing Metal Stent Versus Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis.

BACKGROUND & AIMS: Acute cholecystitis in patients who are not candidates for surgery is often managed with percutaneous transhepatic gallbladder drainage (PT-GBD). Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with a lumen-apposing metal stent (LAMS) is an effective alternative to PT-GBD. We compared the technical success of EUS-GBD versus PT-GBD, and patient outcomes, numbers of adverse events (AEs), length of hospital stay, pain scores, and repeat interventions. METHODS: We performed a retrospective study to compare EUS-GBD versus PT-GBD at 7 centers (5 in the United States, 1 in Europe, and 1 in Asia), from 2013 through 2015, in management of acute cholecystitis in patients who are not candidates for surgery. A total of 90 patients (56 men) with acute cholecystitis (61 calculous, 29 acalculous) underwent EUS-GBD (n = 45) or PT-GBD (n = 45). Data were collected on technical success, clinical success (resolution of symptoms or laboratory and/or radiologic abnormalities within 3 days of intervention), and need for repeat intervention. Characteristics were compared using Student t tests for continuous variables and the chi-square test, or the Fisher exact test, when appropriate, for categorical variables. Adverse events were graded according to American Society for Gastrointestinal Endoscopy definitions and compared using the Fisher exact test. Postprocedure pain scores were compared using the Mann-Whitney U test. RESULTS: Baseline characteristics, type, and clinical severity of cholecystitis were comparable between groups. In the EUS-GBD group, noncautery LAMS were used in 30 patients and cautery-enhanced LAMS were used in 15. Technical success was achieved for 98% of patients in the EUS-GBD and 100% of the patients in the PT-GBD group (P = .88). Clinical success was achieved by 96% of patients in the EUS-GBD group and 91% in the PT-GBD group (P = .20). There was a nonsignificant trend toward fewer AEs in the EUS-GBD group (5 patients; 11%) than in the PT-GBD group (14 patients; 32%) (P = .065). There were no significant differences in the severity of the AEs: mild, 2 in the EUS-GBD group versus 5 in the PT-GBD group (P = .27); moderate, 4 versus 3 (P = .98); severe, 1 versus 3 (P = .62); or deaths, 1 versus 3 (P = .61). The mean postprocedure pain score was lower in the EUS-GBD group than in the PT-GBD group (2.5 vs 6.5; P < .05). The EUS-GBD group had a shorter average length of stay in the hospital (3 days) than the PT-GBD group (9 days) (P < .05) and fewer repeat interventions (11 vs 112) (P < .05). The average number of repeat interventions per patients was 0.2 ± 0.4 EUS-GBD group versus 2.5 ± 2.8 in the PT-GBD group (P < .05). Median follow-up after drainage was comparable in EUS-GBD group (215 days; range, 1-621 days) versus the PT-GBD group (265 days; range, 1-1638 days). CONCLUSIONS: EUS-GBD has similar technical and clinical success compared with PT-GBD and should be considered an alternative for patients who are not candidates for surgery. Patients who undergo EUS-GBD seem to have shorter hospital stays, lower pain scores, and fewer repeated interventions, with a trend toward fewer AEs. A prospective, comparative study is needed to confirm these results.

EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device.

BACKGROUND AND AIMS: In high-risk surgical patients, the treatment of choice of acute cholecystitis is percutaneous transhepatic gallbladder drainage (PTGBD). Recently, a novel endoscopic device containing a lumen-apposing metal stent with an electrocautery (ECE-LAMS) on the tip has been developed. METHODS: High-risk surgical patients with acute cholecystitis who underwent EUS-guided gallbladder drainage (EUS-GBD) with the novel device were retrospectively retrieved from 7 tertiary care referral centers. Main endpoints were technical and clinical success rates, rate of procedural adverse events, and short- and long-term adverse events. RESULTS: Seventy-five patients (mean age, 75 ± 11 years; 36 men) underwent EUS-GBD. The procedure was technically and clinically successful in 98.7% and 95.9% of cases, respectively. Three patients without resolution of cholecystitis died, and 2 patients had procedure-related adverse events: 1 perforation requiring surgery and 1 major bleeding resolved conservatively. The mean follow-up for the entire cohort was 201 ± 226 days. Seven patients (9.6%) died within the first 30 days; 50 patients (71.4%) were alive at the last date of follow-up. Short- and long-term adverse events occurred in 6 patients: 3 had recurrent cholecystitis, 2 had migration of the stent, and 1 developed Bouveret syndrome, all managed nonsurgically. Overall, 8 adverse events (10.7%) occurred in the entire cohort of patients. CONCLUSIONS: The novel ECE-LAMS for high-risk surgical patients with acute cholecystitis is safe, with a high technical and clinical success rate. Future multicenter studies comparing EUS-GBD versus PTGBD are warranted to determine which procedure is safer and clinically more effective for patients with high surgical risk acute cholecystitis.

An international multicenter study comparing EUS-guided pancreatic duct drainage with enteroscopy-assisted endoscopic retrograde pancreatography after Whipple surgery.

BACKGROUND AND AIMS: Endoscopic management of post-Whipple pancreatic adverse events (AEs) with enteroscopy-assisted endoscopic retrograde pancreatography (e-ERP) is associated with high failure rates. EUS-guided pancreatic duct drainage (EUS-PDD) has shown promising results; however, no comparative data have been done for these 2 modalities. The goal of this study is to compare EUS-PDD with e-ERP in terms of technical success (PDD through dilation/stent), clinical success (improvement/resolution of pancreatic-type symptoms), and AE rates in patients with post-Whipple anatomy. METHODS: This is an international multicenter comparative retrospective study at 7 tertiary centers (2 United States, 2 European, 2 Asian, and 1 South American). All consecutive patients who underwent EUS-PDD or e-ERP between January 2010 and August 2015 were included. RESULTS: In total, 66 patients (mean age, 57 years; 48% women) and 75 procedures were identified with 40 in EUS-PDD and 35 in e-ERP. Technical success was achieved in 92.5% of procedures in the EUS-PDD group compared with 20% of procedures in the e-ERP group (OR, 49.3; P < .001). Clinical success (per patient) was attained in 87.5% of procedures in the EUS-PDD group compared with 23.1% in the e-ERP group (OR, 23.3; P < .001). AEs occurred more commonly in the EUS-PDD group (35% vs 2.9%, P < .001). However, all AEs were rated as mild or moderate. Procedure time and length of stay were not significantly different between the 2 groups. CONCLUSIONS: EUS-PDD is superior to e-ERP in post-Whipple anatomy in terms of efficacy with acceptable safety. As such, EUS-PDD should be considered as a potential first-line treatment in post-pancreaticoduodenectomy anatomy when necessary expertise is available.

Flexible percutaneous endoscopic retroperitoneal necrosectomy as rescue therapy for pancreatic necroses beyond the reach of endoscopic ultrasonography: A case series.

Minimally invasive or endoscopic transluminal drainage and necrosectomy are the standard of care for infected pancreatic fluid collections and necroses after pancreatitis. In an endoscopic treatment algorithm, necroses beyond the reach of safe endoscopic access are typically treated by percutaneous drainage. We aimed to evaluate percutaneous minimally invasive necrosectomy using a purely endoscopic technique in patients with extensive necrosis. In patients with necroses beyond safe transluminal reach, the percutaneous drainage canal was used for flexible endoscopic access and dilatation of the tract to 20 mm. Percutaneous endoscopic necrosectomy was carried out through this canal. We present a case series of 14 patients in whom between one and four necrosectomy (median two) sessions were done to remove solid necroses successfully in 13 out of 14 patients. There were no major complications apart from one patient with abdominal compartment syndrome secondary to delayed erosion of the splenic artery. Percutaneous flexible necrosectomy might evolve into an alternative to surgical minimally invasive necrosectomy in anatomical sites beyond transluminal endoscopic reach.

Differential diagnosis of small solid pancreatic lesions.

BACKGROUND AND AIMS: Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at a late stage. Little is known about the incidental finding of early-stage PDAC. The aim of the current study was to determine the etiology of small solid pancreatic lesions (≤15 mm) to optimize clinical management. METHODS: Inclusion criterion for the retrospective study analysis was the incidental finding of primarily undetermined small solid pancreatic lesions ≤15 mm in 394 asymptomatic patients. Final diagnoses were based on histology or cytology obtained by imaging-guided biopsy (and at least 12-month follow-up) and/or surgery. Contrast-enhanced US or contrast-enhanced EUS was performed in 219 patients. RESULTS: The final diagnoses of 394 patients were as follows: 146 PDACs, 156 neuroendocrine tumors, 28 metastases into the pancreas from other primary sites, and 64 various other etiologies. Contrast-enhanced US allowed differential diagnosis of PDAC and non-PDAC in 189 of 219 patients (86%). CONCLUSIONS: Approximately 40% of patients with small solid pancreatic lesions had very early stage PDAC. Approximately 60% of small solid pancreatic lesions ≤15 mm are not PDAC and, therefore, do not require radical surgery. Without preoperative diagnosis, an unacceptably large proportion of patients would be exposed to radical surgery with significant morbidity and mortality.

EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP.

BACKGROUND: A novel lumen-apposing, self-expanding metal stent to perform EUS-guided drainage procedures has been recently developed. The aim of this study was to analyze the safety, technical and clinical effectiveness of this device for EUS-guided choledochoduodenostomy (EUS-CD) with palliative intent. METHODS: Retrospective analysis of all consecutive patients with unresectable malignant distal bile duct obstruction who, between March 2012 and September 2014, underwent EUS-CD using the study devices (AXIOS™ and Hot AXIOS™, Xlumena Inc., Mountain View, CA, USA) after unsuccessful ERCP in seven European centers was carried out. RESULTS: Fifty-seven patients (M/F 31/26; median age 73) underwent EUS-CD using the AXIOS™ stent or the Hot AXIOS™ delivery system. ERCP failure was due to duodenal obstruction in 41 patients (71.9 %) and to inability to cannulate the papilla in the remaining 16 patients (28.1 %). The procedure was technically successful in 56/57 patients (98.2 %), with a mean procedural time of 22.4 min (range 11-65). Clinical success was achieved in 54 of these 56 patients (96.4 %; 94.7 % of the entire cohort). Overall major procedural complication rate was 7 % (two duodenal perforations, one bleeding and one transient cholangitis). During follow-up, 5 out of 54 (9.3 %) patients with clinica success required re-intervention for stent migration in one case and a sump syndrome with transient increase in serum bilirubin concentrations with sludge in the distal duct reservoir in the remaining four patients. CONCLUSIONS: Our study shows that EUS-CD using the AXIOS™ and the Hot AXIOS™ devices is a safe procedure, with high technical and clinical success rates.

EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system: a large retrospective study (with video).

BACKGROUND AND AIMS: A lumen-apposing, self-expanding metal stent incorporated in an electrocautery-enhanced delivery system for EUS-guided drainage of pancreatic fluid collections (PFCs) recently has become available. The aim of this study was to analyze the safety and clinical effectiveness of this newly developed device in this clinical setting. METHODS: This was a retrospective analysis of all consecutive patients with PFCs who underwent EUS-guided drainage using the study device in 13 European centers. RESULTS: Ninety-three patients with PFCs (80% with complex collections) underwent drainage using the study device. Penetration of the PFC was accomplished directly with the study device in 74.2% of patients, and successful stent placement was accomplished in all but 1 patient, mostly without fluoroscopic assistance. Direct endoscopic necrosectomy (DEN) was carried out in 31 of 52 cases (59.6%) of walled-off necrosis and in 2 of 4 cases (50%) of acute peripancreatic fluid collection. Complete resolution of the PFC was obtained in 86 cases (92.5%), with no recurrence during follow-up. Treatment failure occurred in 6 patients because of persistent infection requiring surgery (n = 3), perforation and massive bleeding caused by the nasocystic drainage catheter (NCDC) (n = 2), and the need for a larger opening to extract large necrotic tissue pieces (n = 1). Major adverse events occurred in 5 patients (perforation and massive bleeding caused by the NCDC in 2 patients, 1 pneumoperitoneum and 1 stent dislodgement during DEN, and 1 postdrainage infection) and were mostly not related to the drainage procedure. CONCLUSIONS: EUS-guided drainage with the electrocautery-enhanced delivery system is a safe, easy to perform, and a highly effective minimally invasive treatment modality for PFCs.

A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study.

BACKGROUND AND STUDY AIMS: A novel large-diameter, lumen-apposing, self-expanding metal stent with bilateral flanges was recently developed for endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic pancreatic fluid collections (PFCs). The aim of this study was to evaluate the efficacy and safety of this stent in a large cohort. PATIENTS AND METHODS: Patients with a PFC undergoing EUS-guided drainage with this novel stent were prospectively enrolled in this multicenter cohort study. RESULTS: There were 61 patients: 46 patients (75 %) with walled-off necrosis (WON) and 15 (25 %) with a pancreatic pseudocyst. Stent placement was technically successful in 60 patients (98 %, 95 %CI 95 % - 100 %). Clinical success, defined as resolution of clinical symptoms in combination with a decrease in the PFC size to ≤ 2 cm on imaging, was achieved in 93 % of patients with a pancreatic pseudocyst (95 %CI 77 % - 100 %) and in 81 % of patients with WON (95 %CI 69 % - 94 %). Treatment failure occurred in nine patients (16 %, 95 %CI 6 % - 26 %), including four patients who required surgical intervention. Stent removal was performed in 82 % of patients after a median of 32 days (range 2 - 178) and was rated as easy in all but one patient. In 10 patients, endoscopic stent removal was not performed because of stent migration (n = 3), stent dislodgement during necrosectomy (n = 3), stent removal during surgery (n = 2), or refusal by the patient (n = 2). In total, five major complications were reported (9 %, 95 %CI 2 % - 16 %), including PFC infection (n = 4) and perforation (n = 1). CONCLUSION: EUS-guided drainage using this novel stent is feasible and the clinical results obtained are promising with a low major complication rate.