Biliary drainage in patients with malignant distal biliary obstruction: results of an Italian consensus conference.

BACKGROUND: Malignant Distal Biliary Obstruction (MBDO) is a common event occurring along the natural history of both pancreatic cancer and cholangiocarcinoma. Epidemiological and biological features make MBDO one of the key elements of the clinical management of patients suffering for of pancreatic cancer or cholangiocarcinoma. The development of dedicated biliary lumen-apposing metal stents (LAMS) is changing the clinical work up of patients with MBDO. i-EUS is an Italian network of clinicians and scientists with a special interest in biliopancreatic endoscopy, EUS in particular. METHODS: The scientific methodology was chosen in line with international guidance and in a fashion similar to those applied by broader scientific associations. PICO questions were elaborated and subsequently voted by a broad panel of experts within a simplified Delphi process. RESULTS AND CONCLUSIONS: The manuscripts describes the results of a consensus conference organized by i-EUS with the aim of providing an evidence based-guidance for the appropriate use of the techniques in patients with MBDO.

Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

Italian Survey on Endoscopic Biliary Drainage Approach in Patients with Surgically Altered Anatomy.

Background and Objectives: Biliary drainage (BD) in patients with surgically altered anatomy (SAA) could be obtained endoscopically with different techniques or with a percutaneous approach. Every endoscopic technique could be challenging and not clearly superior over another. The aim of this survey is to explore which is the standard BD approach in patients with SAA. Materials and Methods: A 34-question online survey was sent to different Italian tertiary and non-tertiary endoscopic centers performing interventional biliopancreatic endoscopy. The core of the survey was focused on the first-line and alternative BD approaches to SAA patients with benign or malignant obstruction. Results: Out of 70 centers, 39 answered the survey (response rate: 56%). Only 48.7% of them declared themselves to be reference centers for endoscopic BD in SAA. The total number of procedures performed per year is usually low, especially in non-tertiary centers; however, they have a low tendency to refer to more experienced centers. In the case of Billroth-II reconstruction, the majority of centers declared that they use a duodenoscope or forward-viewing scope in both benign and malignant diseases as a first approach. However, in the case of failure, the BD approach becomes extremely heterogeneous among centers without any technique prevailing over the others. Interestingly, in the case of Roux-en-Y, a significant proportion of centers declared that they choose the percutaneous approach in both benign (35.1%) and malignant obstruction (32.4%) as a first option. In the case of a previous failed attempt at BD in Roux-en-Y, the subsequent most used approach is the EUS-guided intervention in both benign and malignant indications. Conclusions: This survey shows that the endoscopic BD approach is extremely heterogeneous, especially in patients with Roux-en-Y reconstruction or after ERCP failure in Billroth-II reconstruction. Percutaneous BD is still taken into account by a significant proportion of centers in the case of Roux-en-Y anatomy. The total number of endoscopic BD procedures performed in non-tertiary centers is usually low, but this result does not correspond to an adequate rate of referral to more experienced centers.

Bowel Preparation With Polyethylene Glycol 3350 or Fasting Only Before Peroral Single-balloon Enteroscopy: A Randomized European Multicenter Trial.

BACKGROUND: Although bowel preparation before colonoscopy and capsule endoscopy is widely evaluated and usually follows established guidelines, a standard preparation regime for peroral small bowel enteroscopy is yet to be defined.The aim of the present study was to compare small bowel preparation with polyethylene glycol (PEG) and "fasting only" (FO) before peroral single-balloon enteroscopy (SBE). STUDY: We compared small bowel preparation with PEG versus "FO" for peroral SBE in a randomized European multicenter trial. Patients' and procedural characteristics were documented and carefully analyzed. Primary endpoint was the oral intubation depth of the small bowel. A modified Boston preparation scale was used to assess bowel cleansing as a secondary endpoint. RESULTS: In total, 43 patients were enrolled in this study (FO group: n=25; PEG group: n=18). In both groups, patients' characteristics were comparable. The indications for oral enteroscopy were equally distributed in both groups (P=0.894). The oral intubation depth was significantly higher in the PEG versus the FO group (261±87 vs. 203±66 cm; P=0.019; mean±SD), while the quality of bowel preparation was equally sufficient in both groups [complete visualization of the mucosa (Boston preparation scale) 83% versus 76% (P=1.000)]. CONCLUSIONS: Small bowel preparation with PEG for SBE yields significantly deeper intubation as compared with "FO" preparation. As patient comfort and safety was similar in both groups, PEG preparation might be favored, especially if deep intubation of the small bowel is desired. For patients requiring visualization of the proximal jejunum, a FO preparation seems to be sufficient.

Over-the-scope clip closure for treatment of post-pancreaticogastrostomy pancreatic fistula: A case series.

BACKGROUND AND AIM: The over-the-scope clip (OTSC) system is a recently developed endoscopic device. In the last few years, it has been successfully used for severe bleeding or deep wall lesions, or perforations of the gastrointestinal (GI) tract. We hereby report a series of patients with post-pancreaticogastrostomy pancreatic fistula in whom OTSC were used as endoscopic treatment. METHODS: From January 2012 to July 2015, we prospectively collected data on cases of postoperative pancreatic fistula. These patients underwent pancreaticoduodenectomy in a high-volume center of hepatobiliopancreatic surgery. After conservative management, OTSC closure was done by single skilled operators in anesthesiologist-assisted deep sedation. RESULTS: A total of seven patients were enrolled. According to the International Study Group of Pancreatic Surgery criteria, we observed grade B postoperative pancreatic fistula in all cases. All patients were treated with 12/6 t-type OTSC. In two cases, a second clip was successfully applied to a second site adjacent to the original closure site. In all cases, subsequent fluoroscopy showed no contrastographic spreading through the wall. There were no complications related to the procedure itself, not from the endoscopy point of view, nor from the anesthesiological perspective. There were no device malfunctions. Further clinical and endoscopic evaluation was made 8 weeks later and showed no fistula or anastomotic defect recurrence. No patients required additional endoscopic or interventional procedures. CONCLUSION: In consideration of clinical and technical success, OTSC placement in POPF seems to be effective, safe and technically relatively easy to carry out.

Analyses of the Post-reflux Swallow-induced Peristaltic Wave Index and Nocturnal Baseline Impedance Parameters Increase the Diagnostic Yield of Impedance-pH Monitoring of Patients With Reflux Disease.

BACKGROUND & AIMS: Analyses of impedance parameters such as the post-reflux swallow-induced peristaltic wave (PSPW) index and the mean nocturnal baseline impedance (MNBI) have been proposed to increase the accuracy of diagnosis of reflux disease. We assessed whether these improve the diagnostic yield of impedance pH monitoring of reflux disease. METHODS: We performed a prospective study of consecutive patients with proton pump inhibitor-responsive heartburn who underwent 24-hour impedance pH monitoring at hospitals in Italy from January 2011 through December 2013. Reviewers blindly analyzed off-therapy impedance pH tracings from 289 patients with proton pump inhibitor-responsive heartburn, 68 with erosive reflux disease and 221 with non-erosive reflux disease (NERD), along with 50 healthy individuals (controls). The PSPW index, the MNBI, the esophageal acid exposure time, the number of total refluxes, and the bolus exposure were calculated, as well as the symptom association probability (SAP) and the symptom index (SI). RESULTS: In receiver operating characteristic analysis, the area under curve of the PSPW index (0.977; 95% confidence interval, 0.961-0.993) was significantly greater than that of the other impedance pH parameters in identifying patients with reflux disease (P < .001). The PSPW index and the MNBI identified patients with erosive reflux disease with the highest level of sensitivity (100% and 91%, respectively), as well as the 118 pH-positive (99% and 86%) and 103 pH-negative (77% and 56%) cases of NERD. The PSPW index and the MNBI identified pH-negative NERD with the highest level of sensitivity; values were 82% and 52% for the 65 SAP-positive and/or SI-positive cases and 68% and 63% for the 38 SAP-negative and SI-negative cases. Diagnoses of NERD were confirmed by pH-only criteria, including those that were positive on the basis of the SAP or SI, for 165 of 221 cases (75%) and by impedance pH criteria for 216 of 221 cases (98%) (P = .001). CONCLUSIONS: The PSPW index and the MNBI increase the diagnostic yield of impedance pH monitoring of patients with reflux disease. Analysis of impedance pH data by calculating the PSPW index and the MNBI can increase the accuracy of diagnosis of patients with reflux disease, compared with pH-only data.

First-line endoscopic treatment with OTSC in patients with high-risk non-variceal upper gastrointestinal bleeding: preliminary experience in 40 cases.

BACKGROUND AND STUDY AIMS: The over-the-scope clip (OTSC; Ovesco, Tübingen, Germany) is a novel endoscopic clipping device designed for tissue approximation. The device has been used in the closure of fistulas and perforations. We hereby report a series of patients with high-risk non-variceal upper gastrointestinal bleeding (NVUGIB) lesions in whom OTSCs were used as first-line endoscopic treatment. PATIENTS AND METHODS: We prospectively collected and retrospectively analysed data over a period of 12 months from October 2013 to November 2014 from all consecutive patients who underwent emergency endoscopy for acute severe high-risk NVUGIB and were treated with OTSC as primary first-line therapy. RESULTS: We included forty consecutive patients with mean age 69 years (range 25-94 years). All patients were treated with the non-traumatic version of the OTSC system (23 with the 11 mm version and 17 with the 12 mm version). Indications for OTSC treatment included gastric ulcer with large vessel (Forrest IIa) (n = 8, 20 %), duodenal ulcer (Forrest Ib) (n = 7, 18 %), duodenal ulcer with large vessel (Forrest IIa) (n = 6, 15 %), Dieulafoy's lesion (n = 6, 15 %) and other secondary indications (n = 13, 32 %). Technical success and primary haemostasis were achieved in all patients (100 %). No re-bleeding, need for surgical or radiological embolization treatment or other complications were observed during the follow-up period of 30 days. CONCLUSIONS: We conclude OTSC placement as a first-line endoscopic treatment seems to be effective, safe and easy to perform and should be considered in patients with high-risk NVUGIB lesions.

Fully covered self-expanding metal stents for refractory anastomotic colorectal strictures.

BACKGROUND: Some patients with benign colorectal obstruction do not respond to endoscopic balloon dilation. Fully covered self-expandable metal stents (FCSEMSs) have several potential advantages over non-covered stents, including a higher likelihood of retrieval owing to limited local tissue reaction. However, the efficacy and safety of FCSEMSs in benign colorectal strictures have not yet been established. METHODS: Retrospective analysis of prospectively collected data concerning patients with post-surgical benign symptomatic anastomotic colorectal strictures, refractory to endoscopic dilation and in whom FCSEMSs had been placed at our center. Technical success was defined as successful stent placement and deployment at the stricture site. Early clinical success was defined as symptom relief persisting at least for 3 days. Follow-up was based on monthly clinical evaluation and quarterly endoscopic assessment. Endoscopic stent removal was planned on the basis of clinical or endoscopic assessment. Prolonged clinical success was defined as persistent symptom relief during follow-up. RESULTS: Technical and early clinical success were obtained in 16 of 16 (100%) patients. The median follow-up was 21 months. Prolonged clinical success was achieved in 9/16 (56%) cases. There was no major complication, including perforation and bleeding. Stent migration occurred in 3 (19%) cases, in two of them associated with clinical failure. The median stent diameter was significantly higher in patients with successful than in those with unsuccessful clinical outcome (26 vs. 20 mm, P = 0.006). The clinical success rate was 1/6 (17%) in patients who received a 20-22 mm stent and 8/10 (80%) in those who received a 24-26 mm stent, respectively (P = 0.035). CONCLUSIONS: FCSEMSs can represent effective and safe treatment for refractory anastomotic colorectal strictures. Large diameter stents are warranted for better results.

i-Scan high-definition white light endoscopy and colorectal polyps: prediction of histology, interobserver and intraobserver agreement.

PURPOSE: Aim of the study was the evaluation of high-definition white light (HDWL) i-Scan endoscopy for diagnostic prediction of histology, inter- and intraobserver agreement for colorectal polyps. METHODS: In this prospective single-center cohort study, a skilled endoscopist, with HDWL i-Scan, predicted on real-time the histology of 150 polyps from 78 patients undergoing colonoscopy. Subsequently, four endoscopists, not involved in the collection of cases, predicted the polyps' histology (neoplastic vs nonneoplastic) and repeated the assessment after 6 months. RESULTS: Real-time assessment of the lesions predicted a correct histology in 138/150 cases with a sensitivity, specificity, and accuracy of 95, 82, and 92 %, respectively. Sensitivity, specificity, and accuracy of post-acquisition evaluation were 87.7, 61.7, and 82.2 %, respectively. The κ values of inter- and intraobserver agreement of prediction of histology were 0.462 (0.373-0.537) and 0.657 (0.523-0.917). Among the subset of polyps (n = 82) with good/excellent quality image, sensitivity and accuracy of HDWL i-Scan improved (97 %, p = 0.003 and 94 %, p = 0.002, respectively) as well as κ value of interobserver agreement (0.699). CONCLUSIONS: HDWL i-Scan technology helps for characterization of polyps of the colon with good accuracy even if it cannot replace, at the moment, the histopathological examination. Reproducibility among operators is supported by a moderate substantial interobserver and intraobserver agreement.

Fusion radiology in interventional endoscopy (FRIend): a new approach for pancreatic fluid collections.

Background and study aims Fusion imaging consists of overlaying preoperative imaging over live fluoroscopy, providing an augmented live guidance. Since 2017, we have been using a new hybrid operating room (Discovery IGS 740 OR, GE Healthcare) for biliopancreatic endoscopy, combining fusion imaging with traditional endoscopic ultrasound (EUS). This study aimed to assess the advantages that fusion imaging could bring to EUS-guided drainage of post-pancreatitis fluid collections. Patients and methods Thirty-five drainage procedures performed between 2012 and 2019 with traditional guidance and fusion imaging were retrospectively compared, assessing the overall treatment success rate - i. e. symptom improvement with complete PFC emptying - as a primary outcome. Secondary outcomes included technical success rate, time to resolution, hospital stay length, adverse events, recurrence rate, and procedure time. Results Patients treated with standard EUS (n = 17) and with fusion imaging (n = 18) were homogeneous in age, gender, pancreatitis etiology, and indication for drainage; the second group had larger PFCs, more frequently walled-off necrosis than pseudocysts, and were treated more emergently, indicating higher case complexity in this group. During the period when fusion imaging was adopted, procedures had a higher overall treatment success rate than during the period when standard EUS was adopted (83.3 % vs. 52.9 %, P  = 0.075), and complete emptying was reached in less time (61.1 % vs. 23.6 % complete emptying within 90 days, P  = 0.154), differences compatible with random fluctuations. Conclusions This study suggests that fusion imaging in combination with EUS might improve clinical and procedural outcomes of PFC drainage.

Feasibility and Accuracy of Transduodenal Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Solid Lesions Using a 19-Gauge Flexible Needle: A Multicenter Study.

BACKGROUND/AIMS: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the go-to method for obtaining samples from gastrointestinal tract and pancreatic lesions. When the transduodenal approach is utilized, the use of a more flexible needle, such as a nitinol 19-gauge (G) needle, has been recommended. The aim of this study was to evaluate the feasibility and accuracy of 19-G flexible aspiration needles in obtaining samples from solid lesions through a transduodenal approach. METHODS: This was a retrospective analysis of prospectively collected data from eight Italian endoscopy centers. Consecutive patients with solid lesions who underwent transduodenal EUS-FNA with a 19-G flexible needle were included. RESULTS: A total of 201 patients were enrolled. According to histology, EUS, radiology and 12 months of follow-up, 151 patients had malignant lesions and 50 patients had benign lesions. EUS-FNA was feasible in all cases. An adequate histologic sample was obtained in all except eight cases (96.1%). The sensitivity of EUS-FNA was 92.1% (95% confidence interval [CI], 86.8%-95.7%), and the specificity was 100% (95% CI, 90.5%-100%). The positive predictive value was 100% (95% CI, 93.4%-100%), and the negative predictive value was 74% (95% CI, 62.8%-82.7%). The diagnostic accuracy was 93.5% (95% CI, 89.2%-96.5%). CONCLUSION: The transduodenal approach for obtaining samples from solid lesions using a 19-G flexible needle seems feasible and accurate.

Epidemiology, clinical features and diagnostic work-up of cystic neoplasms of the pancreas: Interim analysis of the prospective PANCY survey.

INTRODUCTION: A prospective survey to evaluate the diagnostic workup of cystic pancreatic neoplasms (CPNs) according to the Italian guidelines. METHODS: An online data sheet was built. RESULTS: Fifteen of the 1385 patients (1.1%) had non cystic neoplastic lesions. Forty percent (518/1295) had at least one 1st degree relative affected by a solid tumor of the digestive and extra-digestive organs. Symptoms/signs associated with the cystic lesion were present in 24.5% of the patients. The cysts were localized in the head of the pancreas in 38.5% of patients. Of the 2370 examinations (1.7 examinations per patient) which were carried out for the diagnosis, magnetic resonance imaging was performed as a single test in 48.4% of patients and in combination with endoscopic ultrasound in 27% of the cases. Of the 1370 patients having CPNs, 89.9% had an intraductal papillary mucinous neoplasm (IPMN) (70.1% a branch duct IPMN, 6.2% a mixed type IPMN and 4.6% a main duct IPMN), 12.7% had a serous cystadenoma, 2.8% a mucinous cystadenoma, 1.5% a non-functioning cystic neuroendocrine neoplasm, 0.7% a solid-pseudopapillary cystic neoplasm, 0.3% a cystic adenocarcinoma, and 1.2% an undetermined cystic neoplasm. Seventy-eight (5.7%) patients were operated upon after the initial work-up. CONCLUSIONS: This prospective study offers a reliable real-life picture of the diagnostic work-up CPN.