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This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

Goals: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. Background: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. Methods: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. Results: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P = 0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. Conclusions: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Goals: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. Background: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. Methods: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. Results: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P = 0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. Conclusions: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Up to 20% of health care personnel (HCP) were found to be infected with coronavirus disease (COVID-19)1 in the outbreak in northern Italy.2 Recommendations on patient and HCP protection have been made, such as postponing procedures, triage, use of personal protective equipment (PPE), and creation of differentiated in-hospital pathways.3,4 However, several barriers against the adoption of these strategies exist, including cultural factors and shortages of medical resources; therefore, there are few reports of real-world experiences and outcomes with their adoption.5 The aim of this survey was to investigate the burden of COVID-19 on endoscopic activity in a high-risk area of COVID-19 outbreak, approaches to evaluating patients, adoption and compliance of HCP with protective measures, and initial possible viral transmission outcomes from endoscopy units within a large, community-based setting (both between patients and HCP and between HCP).

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring <40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter ≥40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule >5 mm, and MPD diameter >10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Background and study aims: Cholecystectomy is the standard treatment for acute cholecystitis while percutaneous drainage is reserved for high-risk patients. The aim of the present study was to assess the technical success rate and clinical efficacy of endoscopic gallbladder drainage in patients with acute cholecystitis. Patients and methods: A total of 35 consecutive patients with acute cholecystitis and without residual common bile duct obstruction were retrospectively identified. Patients were stratified according to the pathogenesis and stages of acute cholecystitis, and the morphology of the cystic duct and/or its insertion in the common bile duct. Primary outcomes were technical success and early and late clinical success. Results: Endoscopic retrograde cholangiopancreatography (ERCP) was performed within the first 72 hours in 19 patients (54 %). Technical success was achieved in 29 patients (83 %); drainage was nasocholecystic in 21 ofthese (72 %), plastic stenting in 6 (21 %), and a combined method in 2 (7 %). The pathogenesis and stage of acute cholecystitis, and the morphology both of the cystic duct and its insertion in the common bile duct, did not influence technical success. Clinical success was achieved in 24 cases (83 %) after a median of 3 days (range 2-12). Four patients (14 %) died within 3 days due to septic complications, and one accidentally removed the nasocholecystic drain after 24 hours. Late results, available in 21 patients after a median follow-up of 17 months, showed relapse of acute cholecystitis in 2 (10 %) (both with stents) and of biliary pain in 2 patients (10 %), both of whom had nasocholecystic drainage. Conclusions: Endoscopic gallbladder drainage seems feasible and effective in resolving acute cholecystitis, but only as a temporary measure because of a 20% relapse rate in long-term follow- up. Prospective studies are necessary to identify which patients would benefit most from this endoscopic technique in the short and long term.

Background and study aims: Self-expandable metal stents (SEMS) are an effective palliative treatment for malignant biliary and duodenal strictures. Combined biliary and duodenal stenting remains a technical challenge, however. The aim of this study was to evaluate the technical feasibility of an endoscopic approach to double stenting of malignant biliary and duodenal strictures. Patients and methods: Consecutive patients referred for palliative gastroduodenal and biliary stenting were followed up prospectively. Patients' demographic characteristics, the site and nature of the strictures, success rates, complications, and survival time were recorded. Results: A total of 64 patients underwent double stenting. In 46 patients, biliary obstruction occurred before the onset of duodenal obstruction (by a median of 107 days) (group 1); in 14 patients, biliary obstruction occurred concurrently with duodenal obstruction (group 2); and in four patients the duodenal obstruction preceded the biliary obstruction (by a median of 121 days) (group 3). The duodenal strictures were proximal to the papilla in 31 patients, adjacent to the papilla in 25 patients and distal to the papilla in eight patients. The majority of biliary strictures were in the middle or distal third of the bile duct (in 52/64 patients). Duodenal SEMS were successfully deployed in all patients. Combined endoscopic stenting was successful in 100% of patients in group 1, 86% of patients in group 2, and in 100% of patients in group 3. Taking the three groups together, early complications occurred in 6% of patients and late complications occurred in 16% of patients. The overall median survival after combined stenting was 81 days (range 2-447 days). Conclusions: Combined endoscopic biliary and duodenal SEMS insertion is safe and effective for palliation in malignant biliary and duodenal obstruction. Biliary stenting through the mesh of the duodenal SEMS is technically feasible and has a high success rate. © Georg Thie

Background: The aim of endoscopic treatment in patients with chronic pancreatitis is to achieve decompression of the pancreatic duct, because duct obstruction with increased pressure within the duct is one of the leading causes of pain in these patients. The majority of patients suffer from relapsing pain, thus making it difficult to evaluate the efficacy of therapy. The outcome of endoscopic treatment on pain has been evaluated in patients with continuous pain (present for more than 1 month, at least 5 days per week, requiring daily analgesic therapy) and dilated duct. Methods: Of 343 patients who underwent endotherapy for chronic pancreatitis in a 15-year period, 22 (6.4%)(19 men, mean age 48 years, alcohol abuse 14) had continuous pain and a dilated pancreatic duct. Results: Endotherapy was successful in all patients, with no procedure-related mortality and only mild complications. Pain disappeared, and analgesics could be discontinued in all patients immediately after endotherapy. Six patients are pain free after a mean period of 5.5 years. One pain-free patient died after 3.4 years from myocardial infarction. Five patients were successfully endoscopically re-treated for pain relapses. Four patients underwent surgery for frequent pain relapses after a mean period of 2.5 years. Six patients were lost to follow-up. Conclusions: Endotherapy should be considered as the initial treatment of choice in patients with chronic pancreatitis, dilated duct, and continuous pain. Copyright © 2005 by the American Society for Gastrointestinal Endoscopy.

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BACKGROUND: Endoscopic dilation with stents has been proposed as an alternative to hepaticojejunostomy for management of postoperative biliary strictures. Good long-term results with double 10F plastic stent insertion for 1 year have been reported in 74% to 90% of cases. This is a review of our experience with a more aggressive approach. METHODS: The technique, short-term results, and long-term results of placement of increasing numbers of stents until complete disappearance of the biliary stricture are reported. At each exchange, the maximum possible number of stents in relation to the tightness of the stricture and diameter of the bile duct were inserted. All stents were removed at the end of treatment. RESULTS: The records of 45 of 55 patients with postoperative biliary strictures treated in this manner and observed consecutively were reviewed retrospectively. By intention-to-treat analysis the success rate was 89% (40/45). Early complications developed in 4 (9%) patients (3 cholangitis, 1 pancreatitis) and stent occlusion that required early exchange occurred in 8 (18%) patients. There was 1 death caused by a stroke 2 months after a stent exchange. Forty-two patients completed the protocol (mean number of stents 3.2 +/- 1.3; range 1-6). Mean duration of treatment was 12.1 +/- 5.3 months (range 2-24 months). Two patients died of unrelated causes during follow-up. Among the remaining 40 patients there was no recurrence of symptoms caused by relapsing biliary stricture at a mean follow-up of 48.8 months (range 2-11.3 years). One patient sustained 2 episodes of cholangitis but without stricture recurrence. CONCLUSIONS: This more aggressive approach to endoscopic treatment with stents may improve long-term results for patients with postoperative biliary strictures.

BACKGROUND: Endoscopic dilation with stents has been proposed as an alternative to hepaticojejunostomy for management of postoperative biliary strictures. Good long-term results with double 10F plastic stent insertion for 1 year have been reported in 74% to 90% of cases. This is a review of our experience with a more aggressive approach. METHODS: The technique, short-term results, and long-term results of placement of increasing numbers of stents until complete disappearance of the biliary stricture are reported. At each exchange, the maximum possible number of stents in relation to the tightness of the stricture and diameter of the bile duct were inserted. All stents were removed at the end of treatment. RESULTS: The records of 45 of 55 patients with postoperative biliary strictures treated in this manner and observed consecutively were reviewed retrospectively. By intention-to-treat analysis the success rate was 89% (40/45). Early complications developed in 4 (9%) patients (3 cholangitis, 1 pancreatitis) and stent occlusion that required early exchange occurred in 8 (18%) patients. There was 1 death caused by a stroke 2 months after a stent exchange. Forty-two patients completed the protocol (mean number of stents 3.2 +/- 1.3; range 1-6). Mean duration of treatment was 12.1 +/- 5.3 months (range 2-24 months). Two patients died of unrelated causes during follow-up. Among the remaining 40 patients there was no recurrence of symptoms caused by relapsing biliary stricture at a mean follow-up of 48.8 months (range 2-11.3 years). One patient sustained 2 episodes of cholangitis but without stricture recurrence. CONCLUSIONS: This more aggressive approach to endoscopic treatment with stents may improve long-term results for patients with postoperative biliary strictures.

Background/Aims: This study was designed to evaluate the effectiveness of a diagnostic and therapeutic approach adopted in 118 consecutive patients affected by primary malignancy of the extrahepatic bile duct. Methodology: After diagnostic procedures were performed (ultrasound examination, endoscopic retrograde cholangiopancreatography and computed tomography scan) 25 patients underwent surgical resection. For the remaining 93 patients considered unresectable for cure, stenting by endoscopic means was almost always the only palliative treatment performed. Results: The morbidity and mortality rates were 28% and 8% for patients treated with surgical resection and the curative and overall 3-year survival rate was 30% and 22% respectively. The procedure related morbidity and mortality rates were 13% and 4% for patients endoscopically treated and the median survival rate was 7.3 months. The quality of life evaluated in 68 patients out of 93 was good in 57% of cases, fair in 19% and poor in the remaining 22%. Conclusions: The results of the present study demonstrate the safety and efficacy of endoscopic stenting in the palliative treatment of extrahepatic bile duct cancer while potential cure can only be achieved by radical surgical resection.

Background/Aims: This study was designed to evaluate the effectiveness of radical surgery for liver hydatid disease. Materials and Methods: Hospital charts of 104 consecutive patients with liver hydatidosis observed in our unit during the period 1982-1994 were reviewed. A total of 121 cysts in 89 patients were treated surgically: with cystopericystectomy in 66 and liver resection in 23. Results: The overall incidence of postoperative complications was 19%: 19.7% and 17.1% after cystopericystectomy and liver resection respectively (p = 0.32). Overall postoperative mortality was 1%. Among the 72 patients available for follow-up, only one (1%) had a local recurrence of the disease. Conclusions: Results suggest the safety and efficacy of radical procedures in the surgical management of liver hydatid disease. Total cystopericystectomy is the treatment of choice but liver resection is justified in selected cases.