Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study.

Background and study aims Musculoskeletal disorders (MSDs) and injuries (MSIs) are frequent in gastrointestinal endoscopy. The aim of this study was to assess potential ergonomic advantages of a lighter single-use duodenoscope compared with a standard reusable one for endoscopists performing endoscopic retrograde cholangiopancreatography (ERCP). Methods Three experienced endoscopists performed an ergonomic, preclinical, comparative protocol-guided simulation study of a single-use and a standard reusable duodenoscope using an anatomic bench model. Surface EMG signals from left forearm and arm muscles were recorded. A commercial inertial sensor-based motion capture system was applied to record body posture as well. Results A significant lowering of root mean square amplitude and amplitude distribution of biceps brachii signal (ranging from 13% to 42%) was recorded in all the participants when using a single-use duodenoscope compared with a reusable one. An overall reduction of muscle activation amplitude and duration was also associated with the single-use duodenoscope for forearm muscles, with different behaviors among subjects. Participants spent most of the time in wrist extension (> 80%) and ulnar deviation (> 65%). A consistent pattern of functional range of motion employed for completing all procedures was observed. Conclusions Our study showed that a lighter scope has a promising effect in reducing upper arm muscle activity during ERCP with potential benefit on musculoskeletal health in the ERCP setting.

Redesign of a GI endoscopy unit during the COVID-19 emergency: A practical model.

The pandemic diffusion of the SARS-CoV-2 infection throughout the world required measures to prevent and strategies to control the infection, as well as the reallocation of the hospital structures in order to take care of an increased number of infected patients. Endoscopy Units should be able to perform endoscopic procedures on COVID-19 infected as well as on noninfected patients. The aim of this manuscript is to propose a model for a fast reorganization of the endoscopy department environment in order to safely perform endoscopic procedures in this Pandemic COVID-19 scenario, according to the current advices given by the Scientific Societies.

Wire-guided biliary cannulation: a comprehensive approach to a set of techniques.

Biliary cannulation represent a challenge for the endoscopists that approach to endoscopic retrograde cholangiopancreatography, with non-negligible rate of failure even in expert hands. In order to achieve the biliary tree, two main technique are nowadays mainly used, namely the contrast-assisted cannulation and the wire-guided cannulation (WGC) techniques. The WGC technique is widely used because it seems to be related to higher success rate of cannulation of the common bile duct and, at the same time, to lower rates of complications. Particularly, this approach is associated with lower risk of post endoscopic retrograde cholangiopancreatography pancreatitis, although the pathogenesis of this adverse event is still not completely understood. The outspread of this technique among endoscopists promoted the development of different methods of performing WGC-assisted endoscopic retrograde cholangiopancreatography, such as the touch technique, the no-touch technique and the double guide-wire cannulation. Furthermore, the variety of guide wires and accessories, with their different characteristics, contribute to make the scenario extremely heterogeneous. To date, the published studies did not highlight which is the best strategy that maximizes the rate of success and minimizes the percentage of complications, even because the experience of the operator represents an important variable that conditions the outcomes. The aim of this review is to define state of the art in WGC technique, in order to better understand the possible advantages in using this approach and to bring to light the possible area that may be object of further studies.

A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study.

BACKGROUND AND AIMS: There are 2 techniques described for selective bile duct guidewire cannulation, the touch (T) technique (engaging the papilla with a sphincterotome and then advancing the guidewire) and the no-touch (NT) technique (engaging the papilla only with the guidewire). The aim of this prospective, multicenter randomized study was to compare the outcomes of the 2 guidewire cannulation techniques. METHODS: Three hundred consecutive patients with naïve papillae were enrolled in 2 groups (150 to T group and 150 to NT group). A maximum of 15 biliary cannulation attempts, for no longer than 5 minutes, or a maximum of 5 unintentional cannulations of the pancreatic duct for each group were performed. If biliary cannulation failed, the patient was crossed over to the other technique with the same parameters. The primary outcome was the guidewire cannulation success rate using either the T or NT technique. Secondary outcomes were the number of attempts and cannulation duration, number of pancreatic duct cannulations, and adverse events. RESULTS: The primary cannulation rate was significantly higher in the T group compared with the NT group (88% vs 54%, P < .001), and the cannulation rate was significantly higher using the T technique compared with the NT technique also after crossover (77% vs 17%, P < .001). The mean number of cannulation attempts was 4.6 in the T group versus 5.5 in the NT group (P = .006), and the duration of cannulation before crossover (P < .001) and overall cannulation duration after crossover (P < .001) were significantly lower in the T group. The number of unintended pancreatic duct cannulations was statistically higher using the T technique compared with the NT technique (P = .037). The rates of adverse events did not significantly differ between the 2 groups. CONCLUSIONS: Our results clearly indicated that the T technique is superior to the NT technique for biliary cannulation. (Clinical trial registration number: NCT01954602.).

A systematic review of the management and outcome of ERCP related duodenal perforations using a standardized classification system.

INTRODUCTION: The incidence of duodenal perforation after ERCP ranges from 0.09% to 1.67% and mortality up to 8%. METHODS: This systematic review was registered in Prospective Register of Systematic Reviews, PROSPERO. Stapfer classification of ERCP-related duodenal perforations was used. RESULTS: The systematic search yielded 259 articles. Most frequent post-ERCP perforation was Stapfer type II (58.4%), type I second most frequent perforation (17.8%) followed by Stapfer type III in 13.2% and type IV in 10.6%. Rate of NOM was lowest in Stapfer type I perforations (13%), moderate in type III lesions (58.1%) and high in other types of perforations (84.2% in type II and 84.6% in IV). In patients underwent early surgical treatment (<24 h from ERCP) the most frequent operation was simple duodenal suture with or without omentopexy (93.7%). In patients undergoing late surgical treatment (>24 h from ERCP) interventions performed were more complex. In type I lesions post-operative mortality rate was higher in patients underwent late operation (>24 h). In type I lesions, failure of NOM occurred in 42.8% of patients. In type II failure of NOM occurred in 28.9% of patients and in type III there was failure of NOM in only 11.1%, none in type IV. Postoperative mortality after NOM failure was 75% in type I, 22.5% in type II and none died after surgical treatment for failure of NOM in type III perforations. CONCLUSIONS: This systematic review showed that in patients with Stapfer type I lesions, early surgical treatment gives better results, however the opposite seems true in Stapfer III and IV lesions.

Team work and cytopathology molecular diagnosis of solid pancreatic lesions.

Pancreatic ductal adenocarcinoma (PDAC) is expected to become the second leading cause of cancer-associated death in the next decade or so. It is widely accepted that tumorigenesis is linked to specific alterations in key genes and pancreatic neoplasms are some of the best characterized at the genomic level. Recent whole-exome and whole-genome sequencing analyses confirmed that PDAC is frequently characterized by mutations in a set of four genes among others: KRAS, TP53, CDKN2A/p16, and SMAD4. Sequencing, for example, is the preferable technique available for detecting KRAS mutations, whereas in situ immunochemistry is the main approach for detecting TP53 gene alteration. Nevertheless, the diagnosis of PDAC is still a clinical challenge, involving adequate acquisition of endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) and specific pathological assessment from tissue architecture to specific biomolecular tests. The aim of the present review is to provide a complete overview of the current knowledge of the biology of pancreatic cancer as detected by the latest biomolecular techniques and, moreover, to propose a paradigm for strict teamwork collaboration in order to improve the correct use of diagnostic sources.

Current status of peroral cholangioscopy in biliary tract diseases.

Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted diagnostic and therapeutic procedures. POC can be performed using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope or via the insertion of a small-diameter endoscope directly into the bile duct. POC was first described in the 1970s, but the use of earlier generation devices was substantially limited by the cumbersome equipment setup and high repair costs. For nearly ten years, several technical improvements, including the single-operator system, high-quality images, the development of dedicated accessories and the increased size of the working channel, have led to increased diagnostic accuracy, thus assisting in the differentiation of benign and malignant intraductal lesions, targeting biopsies and the precise delineation of intraductal tumor spread before surgery. Furthermore, lithotripsy of difficult bile duct stones, ablative therapies for biliary malignancies and direct biliary drainage can be performed under POC control. Recent developments of new types of conventional POCs allow feasible, safe and effective procedures at reasonable costs. In the current review, we provide an updated overview of POC, focusing our attention on the main current clinical applications and on areas for future research.

Placement of a new fully covered self-expanding metal stent for postoperative biliary strictures and leaks not responding to plastic stenting.

Fully covered self-expanding metal stents (FCSEMSs) are now being used to treat postoperative biliary strictures (BSs) and biliary leaks (BLs). The aim of this study was to assess the safety and effectiveness of a new FCSEMS (Wallflex) in patients with postoperative BSs and BLs after failure of traditional endoscopic treatment. Between January 2010 and December 2011, 16 patients (10 patients with postcholecystectomy BSs, 4 with postcholecystectomy BLs, and 2 with postorthotopic liver transplantation BSs) were enrolled. The technical and clinical success rate was 100%. All FCSEMSs were removed after a mean of 141 days. Complications occurred in 7 cases: 2 postprocedure pain, 2 mild pancreatitis, 1 early distal, and 2 late proximal FCSEMS migration. The overall long-term clinical success rate was 94% after a mean follow-up of 13 months. In our experience, the placement of FCSEMSs is an effective and secure method of treating refractory postoperative BSs or BLs.

A comparison of uncovered metal stents for the palliation of patients with malignant biliary obstruction: nitinol vs. stainless steel.

BACKGROUND: Various types of self-expandable metal stents have been introduced for the palliation of malignant biliary obstruction. AIMS: To compare the outcomes of WallFlex™ and Wallstent™ uncovered biliary self-expandable metal stents (SEMSs) for the palliation of patients with malignant biliary obstruction. METHODS: Between October 2008 and December 2009, all SEMSs placed for malignant biliary obstruction were WallFlex™: all patients palliated were included in the study. Before October 2008, all the SEMSs placed for malignant biliary obstruction were Wallstent™, and the patients palliated from July 2007 to September 2008 were the comparative group. RESULTS: A total of 58 WallFlex™ and 54 Wallstent™ SEMSs were placed, and efficacious biliary decompression was achieved in all patients. Early complications occurred in 5 patients in the WallFlex™ group and in 3 in the Wallstent™ group (p=ns). Late complications occurred in 6 patients in the WallFlex™ group and in 16 in the Wallstent™ group (p<0.01). The overall patency of the self-expandable metal stent in the WallFlex™ and the Wallstent™ groups was similar (227 days vs. 215 days, p=ns). Mean patient survival was 242 days in the WallFlex™ group and 257 days in the Wallstent™ group (p=ns). CONCLUSIONS: We found no difference in terms of overall patency between the two types of SEMSs, but there was an increased rate of late adverse events in the Wallstent™ group.

Through-the-scope large diameter self-expanding metal stent placement as a safe and effective technique for palliation of malignant colorectal obstruction: a single center experience with a long-term follow-up.

OBJECTIVE: The aim of this study was to evaluate the outcomes of through-the-scope (TTS) large diameter self-expanding metal stent (SEMS) placement for palliation of malignant colorectal obstruction. MATERIAL AND METHODS: Between January 2005 and December 2009, all patients who underwent endoscopic SEMS placement for palliation of malignant colorectal obstruction were prospectively enrolled. RESULTS: Thirty-nine patients (17M and 22F; mean age 75.9 ± 10.6 years, range 50-91) were enrolled. The most frequent location was the sigmoid colon (13 cases). The causes of obstruction were colorectal malignancy in 32 patients and extracolonic malignancy in 7. Technical success was achieved in 36/39 patients (92.3%) and clinical success in 35/39 patients (89.7%). Technical failure was related to female sex (p = 0.04) and the extracolonic etiology of the stricture (p < 0.001). There were three early complications: two procedure-related perforations successfully managed conservatively and one hemorrhage treated with APC. Early complications were related to the location of strictures at the recto-sigmoid junction (p < 0.001). Late complications occurred in 10 patients: 8 of these patients experienced occlusive symptoms (attributable to tumor ingrowth in 5 cases and stool impaction in 3 cases); the remaining 2 were one case of tumor ingrowth with sub-occlusive symptoms and hemorrhage, and one case of distal migration. There was no procedure-related mortality and all complications were managed without surgical intervention. SEMS patency duration was 236 ± 128 days (range 31-497) and mean survival of the patients was 259 ± 121 days (range, 32-511). CONCLUSIONS: In our experience, TTS large-diameter SEMS placement is a safe and effective treatment for palliation of malignant colorectal obstruction.

Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps.

BACKGROUND AND STUDY AIMS: The study examines the outcomes of the 'inject and cut' endoscopic mucosal resection (EMR), for large sessile and flat colorectal polyps. PATIENTS AND METHODS: Between January 2006 and December 2008 all patients referred to our institution for EMR of large polyps were prospectively evaluated. The accuracy of lifting sign and the rate of en bloc and piecemeal resection, complications and recurrence were analyzed. RESULTS: A total of 157 patients with 182 lesions (median size 24.7 +/- 10.2 mm) were included in the study. The most frequent location was the sigmoid colon in 30.2%. Because of non-lifting sign, 5/182 lesions were referred to surgical resection and 177 (43 flat and 134 sessile) were resected, 79 (44.6%) en bloc and 98 (55.4%) piecemeal. There were 20 procedural (11.3%) and 2 late (1.1%) bleeding, 4 post-polypectomy syndrome (2.2%) and 2 perforations (1.1%). Bleeding was related to malignancy (p = 0.01). Intramucosal cancer was observed in 5 cases (2.8%) while invasive cancer was seen in 8 (4.5%). Malignancy was related to polyp size >or=30 mm (p = 0.002). Follow-up colonoscopy was performed in 147 patients with 172 EMR for a mean of 19.8 months. Recurrence was observed in 12/172 (6.9%) polyps. CONCLUSION: Inject and cut EMR is practical and effective with a low risk of complication and local recurrence.

Endoclip-assisted resection of large pedunculated colorectal polyps: technical aspects and outcome.

BACKGROUND: The most common complication of polypectomy is hemorrhage, and various techniques have been used to prevent this complication. AIM: This study evaluates the outcomes of endoclip-assisted polypectomy in patients with large pedunculated colorectal polyps, in comparison with a historical control group of patients treated with endoloop-assisted polypectomy. METHODS: Between January and December 2007, 32 patients with 32 large pedunculated polyps (>or=15 mm) were treated with endoclip-assisted polypectomy (group A). Between January and December 2006, 35 patients with 35 large pedunculated polyps were treated; 33 with endoloop-assisted polypectomy (control, group B) and two cases with endoclips and needle knife, which were included in group A for the analysis. RESULTS: The mean (+/- standard deviation [SD]) size of polyp head was 26.8 +/- 8.1 mm (range 15-50) in group A and 22.3 +/- 4.1 mm (range 15-30) in group B (P = 0.004). In group A, six polyps had a mean (+/-SD) head size of 40.8 +/- 5.8 mm (range 35-50) and were resected with clips and needle knife. In group A, bleeding occurred in two cases (5.9%), which were associated with the presence of cancer at histology (P = 0.006) and were managed by applying new clips. No bleeding occurred in patients of group B and no perforation and post-polypectomy syndrome occurred in either group. There were three (8.8%) cancerized adenomas in group A and one (3%) in group B. Clip application was possible in all patients, while in two cases, loop placement was impossible. CONCLUSIONS: In our experience, endoclip-assisted resection is a safe alternative to endoloop for the resection of large pedunculated colorectal polyps when endoloop placement is difficult or impossible.

Single session versus separate session endoscopic ultrasonography plus endoscopic retrograde cholangiography in patients with low to moderate risk for choledocholithiasis.

BACKGROUND AND AIM: Endoscopic ultrasonography (EUS) is a minimally invasive diagnostic tool for common bile duct stones (CBDS) and may be used to select patients for therapeutic endoscopic retrograde cholangiography (ERC). The aim of this trial is to compare, in patients with non-high-risk for CDBS, the clinical and economic impact of EUS plus ERC performed in a single endoscopic session versus EUS plus ERC in two separate sessions. METHODS: During an 11-month period, all adult patients admitted to the emergency department with suspicion of CBDS were categorized into either high-risk or non-high-risk groups, on the basis of clinical, biochemical, or transabdominal ultrasound findings. Patients in the non-high-risk group were randomized to receive EUS plus ERC in one single or in two separate sessions. RESULTS: Eighty patients were recruited and randomized. Forty patients underwent EUS plus ERC in a single session and 40 patients underwent EUS plus ERC in two separate sessions. Negative EUS examination for CBDS avoided unnecessary ERC to 33 patients. Out of 47 patients with positive EUS (25 from the single session group and 22 from the double session), ERC confirmed the presence of CBDS in 46 cases (EUS sensitivity 100% and specificity 98%). Average time of procedure and hospitalization were significantly shorter in the single session group compared to the two session group. The single session strategy was also less expensive. CONCLUSION: Endoscopic ultrasonography plus ERC with sphincterotomy and stone extraction performed during the same endoscopic session was safe and efficacious with a reduction of procedure time, hospitalization and costs.

Proton pump inhibitor treatment of patients with gastroesophageal reflux-related chronic cough: a comparison between two different daily doses of lansoprazole.

AIM: To compare two different daily doses of lansoprazole given for 12 weeks and to assess the role of gastrointestinal (GI) investigations as criteria for selecting patients. METHODS: Out of 45 patients referred for unexplained chronic persistent cough, 36 had at least one of the GI investigations (endoscopy, 24-h esophageal pH-metry and a 4-week trial of proton pump inhibitor (PPI) therapy) positive and were randomly assigned to receive either 30 mg lansoprazole o.d. or 30 mg lansoprazole b.i.d. for 12 weeks. Symptoms were evaluated at baseline (visit 1) after the PPI test (visit 2) and after the 12-week lansoprazole treatment period (visit 3). RESULTS: Thirty-five patients completed the study protocol. Twenty-one patients (60.0%) reported complete relief from their cough with no difference between the two treatment groups (58.8% and 61.1% had no cough in 30 mg lansoprazole and 60 mg lansoprazole groups, respectively). More than 80% of the patients who had complete relief from their cough at the end of the treatment showed a positive response to the PPI test. CONCLUSION: Twelve weeks of lansoprazole treatment even at a standard daily dose, is effective in patients with chronic persistent cough. A positive response to an initial PPI test seems to be the best criterion for selecting patients who respond to therapy.