Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial.

BACKGROUND: Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS: Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS: 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION: DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.

Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes.

INTRODUCTION: Multiple therapeutic modalities including surgery and rigid and flexible endoscopy have been adopted to manage Zenker's diverticulum (ZD). Minimally invasive flexible endoscopic septotomy (FES) techniques have been increasingly favored over the past 20 years; however, long-term data are still scanty. The aim of this study is to evaluate early and long-term outcomes of FES for naive ZD in a single-center setting. METHODS: From 2010 to 2017, ZD patients treated with FES were included in a prospectively maintained database (NCT03948438). Those who had already been treated surgically or endoscopically were excluded from the analysis. The Dakkak and Bennett dysphagia scale was used to rate the dysphagia. Persistent complete or near-complete resolution of symptoms (Dakkak and Bennett 0 or 1) was defined as clinical success. Postprocedural adverse events were reported according to ASGE lexicon. RESULTS: Overall, 256 consecutive patients were treated. Mean pouch size was 29.8 ± 11.3 mm. The procedure was successfully completed in all scheduled patients, with an early clinical success of 96.1%. Adverse events occurred in 3.5% (9/256) of patients. Eight of them were mild/moderate with no fatal events, whereas one patient required surgery. Recurrences occurred in 31.3% (80/256) of treated patients after a mean time of 9 ± 3 months and 95% of recurrences were treated by a second FES. At an average follow-up of 5.5 years, 95.3% of patients were asymptomatic after a mean number of 1.3 procedures. DISCUSSION: FES is a safe and effective treatment modality for patients with ZD. Recurrence rate is significant; however, endoscopic reintervention is associated with long-term relief of dysphagia.

Underwater cap-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy: a pilot study.

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy (SAA) is technically challenging and associated with a significant number of failures. We examined the feasibility and efficacy of a novel technique for the management of bile duct stones (BDSs), called underwater cap-assisted ERCP (u-ERCP). METHODS : Between June 2019 and February 2020 all patients with SAA with jaundice or cholangitis secondary to BDSs who underwent u-ERCP were enrolled. The u-ERCP technique combines the underwater advancement of a pediatric colonoscope with a transparent cap fitted on the tip of the endoscope. We evaluated the technical success, clinical success, and adverse events associated with u-ERCP. RESULTS : We describe the technique itself and our initial experience in six patients. A complete and successful procedure was carried out in all patients, with the occurrence of no adverse events. None of the patients needed additional treatments for recurrence of symptoms during the follow-up period. CONCLUSIONS : u-ERCP can be considered as a promising alternative for successful endoscopic management of biliary disease in patients with SAA.

Difficult biliary stones in the elderly: Endoscopic retrograde cholangiography - A single surgical tertiary centre experience with follow-up.

BACKGROUND: Pancreaticobiliary diseases and choledocholithiasis are common in elderly patients. Endoscopic treatment of biliary stones represents a well-established mini-invasive technique. However, limited data are available regarding the treatment of 'difficult' biliary stones, especially in the elderly population. The aim of our study is to evaluate the efficacy and safety of therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in patients ≥85 years of age with complex biliary stones. MATERIALS AND METHODS: From January 2015 to January 2017, data from ERCP procedures performed for complex biliary stones were retrospectively collected. The patients were divided into two groups based on their age: Group A - aged 85 years or older (n = 110) and Group B - aged 65 years or younger (n = 62). Demographic data, success, complications and recurrence rates for both groups were reported. RESULTS: Chronic comorbidities (86.3% vs. 24.2%; P < 0.001) and use of antithrombotic drugs (48.2% vs. 19.3%; P < 0.001) were more frequent in the elderly. The technical success rate (95.4% vs. 96.7%; P > 0.6) and complication rate (8.2% vs. 13%; P > 0.2) were not statistically different among the two groups. Periampullary diverticula (PAD) were observed more frequently in Group A (38.1% vs. 17.7%; P < 0.006). More patients from Group B underwent cholecystectomy during the same admission (8.2% vs. 42.3%; P < 0.001). The recurrence rate was not different among the groups (7.6% vs. 5%; P > 0.5). PAD was identified as the risk factor for recurrence (P < 0.02). CONCLUSION: ERCP in the elderly was found to be a safe procedure, carrying a high degree of success for the treatment of difficult biliary stones.

New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video).

BACKGROUND AND AIMS: In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents. METHODS: This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs). RESULTS: Thirty-eight patients (11 women [28.9%]; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 [64.2%] biliary and 19 [35.8%] pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred. CONCLUSIONS: The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.).

Peroral endoscopic septotomy for short-septum Zenker's diverticulum.

BACKGROUND: Treatments of Zenker's diverticulum aim to dissect the cricopharyngeal muscle, removing the underlying source of dysfunction. This is difficult in patients with a short-septum (≤ 20 mm) diverticulum because the limited anatomical space restricts the operating area for either rigid or flexible endoscopic approaches. The aim of this study was to investigate the efficacy and safety of a novel third-space approach, peroral endoscopic septotomy (POES), for treating symptomatic patients with short-septum Zenker's diverticulum. METHODS: All patients with short-septum Zenker's diverticulum who were referred for endoscopic repair from September 2017, were considered for the study. Outcomes included procedure-related adverse events and symptom improvement. The Dakkak - Bennett score was used to quantify dysphagia. RESULTS: 20 patients (men 12, women 8; mean age 67.9 years [SD 14.3]) underwent POES. All procedures were performed with patients under deep sedation. Mean size of Zenker's diverticulum was 17.5 mm (SD 3.0) and mean dysphagia score was 2.7 (SD 0.5). Average procedure time was 13.8 minutes (SD 5.1). No intra- or post- procedural adverse events occurred. Septal myotomy was successfully completed in all patients. Dysphagia significantly improved in 19 out of 20 patients. Dakkak - Bennett score improved to 0.3 (SD 0.5), P < 0.0001). No recurrences were reported in a mean follow-up time of 12.0 months (SD 3.7, range 6 - 20). CONCLUSIONS: POES may be considered as a potential alternative for the treatment of short-septum Zenker's diverticulum. Further data are required to validate this technique and compare it with already available rigid and flexible approaches.

Assessing impending hazards from summit eruptions: the new probabilistic map for lava flow inundation at Mt. Etna.

The development of probabilistic maps associated with lava flow inundation is essential to assess hazard in open vent volcanoes, especially those that have highly urbanized flanks. In this study we present the new lava flow hazard map linked to the summit eruptions of Mt. Etna, which has been developed using a probabilistic approach that integrates statistical analyses of the volcanological historical data with numerical simulations of lava flows. The statistical analysis of volcanological data (including vent location, duration and lava volumes) about all summit eruptions occurred since 1998 has allowed us both to estimate the spatiotemporal probability of future vent opening and to extract the effusion rate curves for lava flow modelling. Numerical simulations were run using the GPUFLOW model on a 2022 Digital Surface Model derived from optical satellite images. The probabilistic approach has been validated through a back-analysis by calculating the fit between the expected probabilities of inundation and the lava flows actually emplaced during the 2020-2022 period. The obtained map shows a very high probability of inundation of lava flows emitted at vents linked to the South East Crater, according to the observation of the eruptive dynamics in the last decades.

Weight loss and body composition changes following three sequential cycles of ketogenic enteral nutrition.

BACKGROUND: Ketogenic enteral nutrition (KEN) is a modification of the protein sparing modified fast in which a protein solution is introduced with a continuous infusion through a nasogastric tube over 10-days cycles. The aim of the study was to perform a retrospective analysis of the safety, compliance, weight loss and body composition changes after 3 sequential 10-days cycles of KEN therapy. MATERIALS AND METHODS: From a large number of patients who underwent KEN therapy in our department over a 5-year period, we selected 188 patients who participated in 3 KEN cycles with 10-13 days of break between them. Before and after the treatment cycles, body composition was analyzed by bioelectric impedance; a final assessment was made 10 days after the end of last cycle. During each rest period all the patients were on a low-carbohydrate, normal caloric diet. RESULTS: Most patients (97%) successfully tolerated the nasogastric treatment and lost an average of 14.4 kg of body weight, 10.6 kg of fat mass and 3.4 kg of body cell mass. Adverse effects were recorded as mild gastric hypersecretion (2%) and constipation (5%). Patients continued to lose fat during the 10-day follow up period after the end of each KEN Cycle. This effect may be explained by abnormality of water distribution during the rapid weight loss inducing the observed change in fat mass. CONCLUSION: Ten-days KEN treatment cycles can induce rapid weight loss and reduction of fat mass in obese patients. Furthermore, preservation of lean mass can be achieved by infusing 1.9 g of protein/kg of BCM.

Percutaneous endoscopic gastrostomy and jejunostomy: Indications and techniques.

Nutritional support is essential in patients who have a limited capability to maintain their body weight. Therefore, oral feeding is the main approach for such patients. When physiological nutrition is not possible, positioning of a nasogastric, nasojejunal tube, or other percutaneous devices may be feasible alternatives. Creating a percutaneous endoscopic gastrostomy (PEG) is a suitable option to be evaluated for patients that need nutritional support for more than 4 wk. Many diseases require nutritional support by PEG, with neurological, oncological, and catabolic diseases being the most common. PEG can be performed endoscopically by various techniques, radiologically or surgically, with different outcomes and related adverse events (AEs). Moreover, some patients that need a PEG placement are fragile and are unable to express their will or sign a written informed consent. These conditions highlight many ethical problems that become difficult to manage as treatment progresses. The aim of this manuscript is to review all current endoscopic techniques for percutaneous access, their indications, postprocedural follow-up, and AEs.

Flexible endoscopic treatment for Zenker's diverticulum: from the lumen to the third space.

Zenker's diverticulum (ZD) is a rare outpouching of the esophageal mucosa herniating posteriorly through Killian's triangle. Treatments of ZD aim to dissect the cricopharyngeal muscle to remove the underlying dysfunctional condition. In the last decade, a septotomy performed utilizing a flexible endoscope has been reported as a safe and effective alternative to both open surgery and rigid endoscopic diverticulotomy. More recently, Li et al described a novel endoscopic technique to treat ZD, named "submucosal tunneling endoscopic septum division", inspired by the peroral endoscopic myotomy (POEM) procedure developed for achalasia. Subsequently, the term Z-POEM was introduced and has become the most frequently used acronym to define the tunneling technique for ZD. This article describes the flexible therapeutic endoscopic strategies for treating ZD, including the novel third space approach, which seems to show promising potential in terms of clinical efficacy and safety.

Malignant gastric outlet obstruction: Which is the best therapeutic option?

Malignant gastric outlet obstruction (MGOO) is a clinical condition characterized by the mechanical obstruction of the pylorus or the duodenum due to tumor compression/infiltration, with consequent reduction or impossibility of an adequate oral intake. MGOO is mainly secondary to advanced pancreatic or gastric cancers, and significantly impacts on patients' survival and quality of life. Patients suffering from this condition often present with intractable vomiting and severe malnutrition, which further compromise therapeutic chances. Currently, palliative strategies are based primarily on surgical gastrojejunostomy and endoscopic enteral stenting with self-expanding metal stents. Several studies have shown that surgical approach has the advantage of a more durable relief of symptoms and the need of fewer re-interventions, at the cost of higher procedure-related risks and longer hospital stay. On the other hand, enteral stenting provides rapid clinical improvement, but have the limit of higher stent dysfunction rate due to tumor ingrowth and a subsequent need of frequent re-interventions. Recently, a third way has come from interventional endoscopic ultrasound, through the development of endoscopic ultrasound-guided gastroenterostomy technique with lumen-apposing metal stent. This new technique may ideally encompass the minimal invasiveness of an endoscopic procedure and the long-lasting effect of the surgical gastrojejunostomy, and brought encouraging results so far, even if prospective comparative trial are still lacking. In this Review, we described technical aspects and clinical outcomes of the above-cited therapeutic approaches, and discussed the open questions about the current management of MGOO.

Lumen-apposing metal stents for malignant biliary obstruction: Is this the ultimate horizon of our experience?

In the last years, endoscopic ultrasonography (EUS) has evolved from a purely diagnostic technique to a more and more complex interventional procedure, with the possibility to perform several type of therapeutic interventions. Among these, EUS-guided biliary drainage (BD) is gaining popularity as a therapeutic approach after failed endoscopic retrograde cholangiopancreatography in distal malignant biliary obstruction (MBO), due to the avoidance of external drainage, a lower rate of adverse events and re-interventions, and lower costs compared to percutaneous trans-hepatic BD. Initially, devices created for luminal procedures (e.g., luminal biliary stents) have been adapted to the new trans-luminal EUS-guided interventions, with predictable shortcomings in technical success, outcome and adverse events. More recently, new metal stents specifically designed for transluminal drainage, namely lumen-apposing metal stents (LAMS), have been made available for EUS-guided procedures. An electrocautery enhanced delivery system (EC-LAMS), which allows direct access of the delivery system to the target lumen, has subsequently simplified the classic multi-step procedure of EUS-guided drainages. EUS-BD using LAMS and EC-LAMS has been demonstrated effective and safe, and currently seems one of the most performing techniques for EUS-BD. In this Review, we summarize the evolution of the EUS-BD in distal MBO, focusing on the novelty of LAMS and analyzing the unresolved questions about the possible role of EUS as the first therapeutic option to achieve BD in this setting of patients.

Endoscopic ultrasound-guided gallbladder drainage by transduodenal lumen-apposing metal stent in a patient with Roux-en-Y reconstruction.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is increasingly recognized as an effective and safe treatment option in patients with acute cholecystitis (AC) who are deemed unfit for cholecystectomy. Recent studies suggest that an endoscopic approach to biliary decompression may reduce patient discomfort and procedure-related costs compared with the standard percutaneous transhepatic GBD, while maintaining high rates of technical and clinical success. Here we present a case of a EUS-GBD in an elderly patient with AC and with altered anatomy due to a previous partial gastrectomy with Roux-en-Y reconstruction for gastric cancer. The linear array echoendoscope was carefully advanced within the afferent limb until EUS gallbladder visualization was achieved. Transmural GBD was then performed by placement of an electrocautery-enhanced lumen-apposing metal stent. If alternative treatments are precluded, EUS-GBD in patients with AC and altered anatomy is a feasible and effective therapeutic option when performed by experienced endoscopists.