A New Step-Up Dual Endoscopic Approach for Large-Size Infected Pancreatic Necrosis: Percutaneous Endoscopic Necrosectomy Followed by Transluminal Endoscopic Drainage/Necrosectomy.

BACKGROUND: Acute pancreatitis in 10% to 20% of cases can be associated with necrosis of the pancreatic gland, peripancreatic tissue, or both. We report a case series of a new endoscopic approach to treat infected pancreatic necrosis (IPN). PATIENTS AND METHODS: Consecutive patients with IPN, extending from the perigastric area up to the paracolic gutters or into the pelvis, were prospectively studied from January 2017 to June 2022. The treatment protocol was radiologic percutaneous drainage as the first step, followed by fully covered metal stent placement (FC-SEMS) in the track of the catheter. Percutaneous endoscopic necrosectomy (PEN) was performed 2 to 4 days later using a flexible endoscope through the percutaneous tract. About 2 to 4 weeks later, when a matured sac was visible, EUS-guided endoscopic transluminal drainage (ETD) with lumen-apposing metal stents (LAMS) was performed. Control of sepsis with resolution of collection(s) was the primary outcome measure. RESULTS: We included 18 patients, males in 50% of cases with age 60±12 years old. Most frequent cause of pancreatitis was biliary (7 cases) followed by alcoholic in 6 cases; in 3 cases pancreatitis was caused by hyperlipemia and in 2 cases was idiopathic. Mean size of WON was 18±2 cm. For PEN, SEMSs used were esophageal FC-SEMS. LAMS used for ETD were Hot Axios, Hot Spaxus and Nagistent. Mean time of endoscopic intervention for PEN and ETD was 18±3 and 37±4 days, respectively. In 5 cases adverse events occurred: 3 cases of overinflations resolved with introduction of Verres needles in abdomen. In 2 cases postprocedural GI bleeding required endoscopic intervention. In all cases control of sepsis was reached together with resolution of collections. No cases of deaths were observed. CONCLUSIONS: Step-up percutaneous and transluminal endoscopic necrosectomy therapy is an effective strategy for large-size IPN with combined central and peripheral necrosis.

Over-the-scope Technique for Partially Covered Self-expandable Metal Stent Placement to Treat Duodenal Perforation during EUS.

BACKGROUND AND AIMS: Although endoscopic ultrasound (EUS) is generally safe, duodenal perforation may occur during the procedure. When the iatrogenic break is wide, endoscopic positioning of a covered self- expandable metal stent is indicated to avoid a more invasive surgical approach. We evaluated the efficacy of the 'over-the-scope stenting' (OTSS) technique to treat iatrogenic duodenal perforations occurred during EUS. METHODS: Data of patients with large iatrogenic duodenal perforations treated with OTSS procedure were collected in 5 centers. Technical success was defined as a correct stent placement on the perforation site, and clinical success as complete healing of the duodenal leak at stent removal 3 weeks later. RESULTS: A total of 15 (7 males; median age: 78 years, range 47-91) patients were included in this series. A correct stent positioning was achieved in all cases (technical success: 100%), and the perforation was healed in all, apart from one patient at stent removal (clinical success: 93%). This patient was successfully treated with a novel stent placement. No immediate post-procedural adverse events occurred, and no need for emergency surgery was recorded. In one (6.7%) patient, stent migration occurred 10 days after positioning, and it was spontaneously expulsed with stool movement without complications two days later. CONCLUSIONS: Our data showed that the OTTS technique for partially covered self-expandable metal stent placement is feasible, safe and effective to tread large iatrogenic duodenal perforation occuring during EUS.

Endoscopic Submucosal Dissection for Subepithelial Tumor Treatment in the Upper Digestive Tract: A Western, Multicenter Study.

Background/Aims: Endoscopic submucosal dissection (ESD) has been proposed for removal of gastrointestinal subepithelial tumors (GI-SETs), but data are still scanty. This study aimed to report a case series from a western country. Patients and Methods: Data of patients with upper GI-SETs suitable for ESD removal observed in 4 centers were retrospectively reviewed. Before endoscopic procedure, the lesion was characterized by endosonographic evaluation, histology, and CT scan. The en bloc resection and the R0 resection rates were calculated, as well as incidence of complications, and the 1-year follow-up was reported. Results: Data of 84 patients with esophageal (N = 13), gastric (N = 61), and duodenal (N = 10) GI-SETs were collected. The mean diameter of lesions was 26 mm (range: 12-110 mm). There were 17 gastrointestinal stromal tumors, 12 neuroendocrine tumors, 35 leiomyomas, 18 lipomas, and 2 hamartomas. En bloc and R0 resection were achieved in 83 (98.8%) and in 80 (95.2%) patients, respectively. Overall, a complication occurred in 11 (13.1%) patients, including bleeding (N = 7) and perforation (N = 4). Endoscopic approach was successful in all bleedings, but 1 patient who required radiological embolization, and in 2 perforations, while surgery was performed in the other patients. Overall, a surgical approach was eventually needed in 5 (5.9%), including 3 in whom R0 resection failed and 2 with perforation. Conclusions: Our study found that ESD may be an effective and safe alternative to surgical intervention for both benign and localized malignant GI-SETs.

Introdução/objetivos: A dissecção endoscópica da submucosa (ESD) tem sido proposta para a exérese de tumores subepiteliais gastrointestinais (GI-SETs), embora a literatura seja escassa. Este estudo teve como objetivo reportar uma série de casos de um país ocidental. Métodos: Coorte retrospectiva incluindo doentes com SETs do tubo digestivo superior submetidos a ESD em 4 centros (1 ano de follow-up). Antes do procedimento, a lesão foi caracterizada por ecoendoscopia, histologia e tomografia computadorizada. Foram avaliadas as taxas de ressecção em bloco e R0, bem como a incidência de complicações. Resultados: Incluídos 84 doentes com GI-SETs esofágicos (N = 13), gástricos (N = 61) e duodenais (N = 10). O diâmetro médio das lesões foi de 26 mm (intervalo 12­110 mm) ­ 17 tumores do estroma gastrointestinal, 12 tumores neuroendócrinos, 35 leiomiomas, 18 lipomas e 2 hamartomas. A resseção foi em bloco e R0 em 83 (98.8%) e em 80 (95.2%) doentes, respectivamente. Globalmente, ocorreram complicações em 11 (13.1%) doentes, incluindo hemorragia (N = 7) e perfuração (N = 4). A terapêutica endoscópica foi eficaz em todas as hemorragias exceto em 1 doente que necessitou de embolização radiológica e em 2 perfurações (submetidas a cirurgia). No geral, a abordagem cirúrgica foi necessária em 5 (5.9%) ­ 3 doentes com resseção R1 e 2 com perfuração. Conclusões: A ESD pode ser uma alternativa eficaz e segura à intervenção cirúrgica para GI-SETs benignos e malignos localizados.

Transabdominal self-expandable metal stent placement as a rescue therapy for drainage of walled-off necrosis.

Video 1CT scan of a walled-off necrosis in the right pararenal space extended to the iliac area.

Endoscopic ultrasonography-guided biliary drainage for malignant jaundice by using electrocautery-enhanced lumen-apposing metal stents (Hot-SPAXUS stent).

Background: Biliary drainage with endoscopic retrograde cholangiopancreatography (ERCP) for tumoral jaundice fails in a certain percentage of patients. In these patients, endoscopic ultrasonography-guided lumen-apposing metal stents (LAMS) with electrocautery-enhanced (ECE) technology allows a single-step, radiation-free palliative treatment. Methods: We reviewed the data of patients who underwent choledochoduodenostomy with placement of ECE-LAMS (Hot-SPAXUS stent) after ERCP failure in a single tertiary center. Technical and clinical success rates were calculated and adverse events recorded. Results: Data of 15 patients (8 male, median age 72 years) were collected. The procedure was technically successful in all patients, whilst clinical success was achieved in 14 (93.3%) patients. One (6.7%) patient presented delayed bleeding treated endoscopically. At follow up, stent occlusion with recurrence of jaundice occurred in 2 (13.3%) patients, due to food impaction (n=1), or neoplastic ingrowth (n=1). Conclusion: Our results suggest that the Hot-SPAXUS procedure is effective and safe for palliative treatment in patients with distal biliary malignant obstruction after failure of ERCP.

Timing of endoscopic therapy for acute bilio-pancreatic diseases: a practical overview.

Diseases of the pancreas and hepatobiliary tree often require a therapeutic approach with endoscopic retrograde cholangiopancreatography (ERCP), generally following noninvasive imaging techniques. Appropriate indications and the correct timing for urgent ERCP would benefit both patients and clinicians and allow optimal utilization of health resources. Indications for urgent (<24 h) ERCP include severe acute cholangitis, acute biliary pancreatitis with cholangitis, biliary or pancreatic leaks, in the absence of percutaneous drainage, and severe acute cholecystitis in patients who are unfit for surgery and do not respond to conservative management. In patients who have severe acute biliary pancreatitis with ongoing biliary obstruction but without cholangitis, early (<48-72 h) ERCP is indicated. This overview aims to provide decisional flowcharts that can be easily used for managing patients with acute bilio-pancreatic disorders when they are referred to the Emergency Department.

Endoscopic Submucosal Dissection for Visible Dysplasia Treatment in Ulcerative Colitis Patients: Cases Series and Systematic Review of Literature.

BACKGROUND AND AIMS: Ulcerative colitis [UC] patients are at an increased risk of developing colorectal cancer due to chronic inflammation. Endoscopic submucosal dissection [ESD] allows removal of non-invasive neoplastic lesions in the colon, but few data are available on its efficacy in UC patients. METHODS: Data from consecutive UC patients diagnosed with visible dysplastic lesions in the colon who underwent ESD were evaluated. The en bloc removal, R0 resection and complication rates were calculated. Local recurrence and metachronous lesions during follow-up were identified. A systematic review of the literature with pooled data analysis was performed. RESULTS: A total of 53 UC patients [age: 65 years; range 30-74; M/F: 31/22] underwent ESD. The en bloc resection rate was 100%, and the R0 resection rate was 96.2%. Bleeding occurred in seven [13.2%] patients, and perforation in three [5.6%] cases, all treated at endoscopy. No recurrence was observed, but two metachronous lesions were detected. Data from six other studies [three Asian and three European] were available. By pooling data, en bloc resection was successful in 88.4% (95% confidence interval [CI] = 83.5-92) of 216 lesions and in 91.8% [95% CI = 87.3-94.8] of 208 patients. R0 resection was achieved in 169 ESDs, equivalent to a 78.2% [95% CI = 72.3-83.2] rate for lesions and 81.3% [95% CI = 75.4-86] rate for patients. No difference between European and Asian series was noted. CONCLUSIONS: This pooled data analysis indicated that ESD is a suitable tool for safely and properly removing non-invasive neoplastic lesions on colonic mucosa of selected UC patients.

Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score.

OBJECTIVES: We sought (i) to validate a new prediction rule of mortality (Progetto Nazionale Emorragia Digestiva (PNED) score) on an independent population with non-variceal upper gastrointestinal bleeding (UGIB) and (ii) to compare the accuracy of the Italian PNED score vs. the Rockall score in predicting the risk of death. METHODS: We conducted prospective validation of analysis of consecutive patients with UGIB at 21 hospitals from 2007 to 2008. Outcome measure was 30-day mortality. All the variables used to calculate the Rockall score as well as those identified in the Italian predictive model were considered. Calibration of the model was tested using the chi2 goodness-of-fit and performance characteristics with receiver operating characteristic (ROC) analysis. The area under the ROC curve (AUC) was used to quantify the diagnostic accuracy of the two predictive models. RESULTS: Over a 16-month period, data on 1,360 patients were entered in a national database and analyzed. Peptic ulcer bleeding was recorded in 60.7% of cases. One or more comorbidities were present in 66% of patients. Endoscopic treatment was delivered in all high-risk patients followed by high-dose intravenous proton pump inhibitor in 95% of them. Sixty-six patients died (mortality 4.85%; 3.54-5.75). The PNED score showed a high discriminant capability and was significantly superior to the Rockall score in predicting the risk of death (AUC 0.81 (0.72-0.90) vs. 0.66 (0.60-0.72), P<0.000). Positive likelihood ratio for mortality in patients with a PNED risk score >8 was 16.05. CONCLUSIONS: The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.

Predictive factors of mortality from nonvariceal upper gastrointestinal hemorrhage: a multicenter study.

OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment.

Pre-operative Diagnosis of Pancreatic Neuroendocrine Tumors with Endoscopic Ultrasonography and Computed Tomography in a Large Series.

BACKGROUND AND AIMS: Diagnosis of pancreatic neuroendocrine tumors (p-NETs) is frequently challenging. We describe a large series of patients with p-NETs in whom both pre-operative Computed Tomography (CT) and Endoscopic Ultrasonography (EUS) were performed. METHODS: This was a retrospective analysis of prospectively collected sporadic p-NET cases. All patients underwent both standard multidetector CT study and EUS with fine-needle aspiration (FNA). The final histological diagnosis was achieved on a post-surgical specimen. Chromogranin A (CgA) levels were measured. RESULTS: A total of 80 patients (mean age: 58 +/- 14.2 years; males: 42) were enrolled. The diameter of functioning was significantly lower than that of non-functioning p-NETs (11.2 +/- 8.5 mm vs 19.8 +/- 12.2 mm; P = 0.0004). The CgA levels were more frequently elevated in non-functioning than functioning pNET patients (71.4% vs 46.9%; P = 0.049). Overall, the CT study detected the lesion in 51 (63.7%) cases, being negative in 26 (68.4%) patients with a tumor

PDX-1 mRNA expression in endoscopic ultrasound-guided fine needle cytoaspirate: perspectives in the diagnosis of pancreatic cancer.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided fine needle aspiration is routinely used in the diagnostic work up of pancreatic cancer but has a low sensitivity. Studies showed that Pancreatic Duodenal Homeobox-1 (PDX-1) is expressed in pancreatic cancer, which is associated with a worse prognosis. We aimed to verify whether the assessment of PDX-1 in endoscopic ultrasound-guided fine needle aspiration samples may be helpful for the diagnosis of pancreatic cancer. METHODS: mRNA of 54 pancreatic cancer and 25 cystic lesions was extracted. PDX-1 expression was assessed by Real-Time PCR. RESULTS: In all but two patients with pancreatic cancer, PDX-1 was expressed and was found positive in 7 patients with pancreatic cancer in which cytology was negative. The positivity was associated with a probability of 0.98 (95% CI 0.90-1.00) of having cancer and the negativity with one of 0.08 (95% CI 0.01-0.27). The probability of cancer rose to 1.00 (95% CI 0.97-1.00) for patients positive to both PDX-1 and cytology and fell to 0.0 (95% CI 0.00-0.15) in patients negative for both. CONCLUSIONS: PDX-1mRNA is detectable in samples of pancreatic cancer. Its quantification may be helpful to improve the diagnosis of pancreatic cancer.