Reply: "Percutaneously guided or ultrasound-guided splenic punctures are safe procedures with a high diagnostic performance".

We appreciate the interest shown in our article "Endoscopic ultrasound-guided fine-needle aspiration for splenomegaly and focal splenic lesion: is it safe, effective and necessary?", as well as the academic discussion raised by gastroenterology-ultrasound experts in the letter to the editor. In the discussion of our article, we mention that EUS-FNA is necessary and/or the first option in splenomegaly and/or small focal splenic lesions where percutaneous biopsy are limited, when difficulty accessing the focal splenic lesions, in obese patients and in those with ascites, recent abdominal surgery or a poor acoustic window.

Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial.

GOALS: The aim of this study was to compare a new, full-spectrum endoscope (Fuse; EndoChoice, Alpharetta, GA) to standard forward-viewing colonoscopy in the detection of colorectal neoplasms. BACKGROUND: Colonoscopy, the gold standard for the detection of colorectal cancer, fails to detect 22% to 28% of polyps, increasing the risk of interval cancer. Endoscopic improvement of the adenoma detection rate decrease interval carcinomas. Full-spectrum endoscopy (FUSE) (330-degree field of view), in a tandem study, has been shown to reduce the adenoma miss rate. STUDY: Prospective, randomized study of 249 patients in patients referred from the colorectal screening program with a positive fecal occult blood test (FOBT). Patients were randomized to standard forward-viewing colonoscopy (170 degrees) or to full-spectrum colonoscopy with the Fuse system (330 degrees). Study variables were the adenoma detection rate, the polyp detection rate, the mean number of adenomas per procedure, the lesions detected according to the location, morphology and size, cecal intubation rate, total procedure time, insertion time to the cecum, therapeutic success, and adverse events. RESULTS: The Fuse system did not produce a significantly higher adenoma detection rate than standard forward-viewing colonoscopy (FUSE 73.1% vs. standard colonoscopy 68.1%; P=0.47) but did have a significantly longer insertion time (FUSE 6.2 min vs. standard colonoscopy 4.2 min; P< 0.001). Further analysis failed to reveal any significant difference in polyp/adenoma detection rates by lesion size or colonic section. CONCLUSIONS: FUSE did not detect significantly more colorectal neoplasia than forward viewing colonoscopy in a medium-risk CRC screening population with positive FOBT.

Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.

BACKGROUND AND AIMS: Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. METHODS: This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. RESULTS: The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. CONCLUSIONS: An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.

Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey.

BACKGROUND: EUS-guided cholangiopancreatography (ESCP) allows transmural access to biliopancreatic ducts when ERCP fails. Data regarding technical details, safety, and outcomes of ESCP are still unknown. OBJECTIVE: To evaluate outcomes of ESCP in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist. DESIGN: Multicenter retrospective study. SETTING: Public health system hospitals with experience in ESCP in Spain. PATIENTS: A total of 125 patients underwent ESCP in 19 hospitals, with an experience of <20 procedures. INTERVENTION: ESCP. MAIN OUTCOME MEASUREMENTS: Technical success and complication rates in the initial phase of implantation of ESCP are described. The influence of technical characteristics and endoscopist features on outcomes was analyzed. RESULTS: A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula. LIMITATIONS: Retrospective study. CONCLUSION: Outcomes of ESCP during its implantation stage reached a technical success rate of 67.2%, with a complication rate of 23.2%. Intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure.

ERCP during pregnancy.

BACKGROUND AND AIMS: ERCP during pregnancy is always challenging for the entire team performing the endoscopic intervention. In this study techniques and different interventional aspects used at several centres about the clinical experience on ERCP in pregnant women are analyzed. PATIENTS AND METHODS: the practice on ERCP in pregnant women in six centres during a period of ten years is reported. RESULTS: eleven patients were included in the study. Mean age was 30.6 years. Indication for ERCP was always symptomatic common bile duct stone (CBDS) disease. Before the procedure abdominal ultrasound was performed at all times and magnetic resonance cholangiopancreatography in four occasions. Conscious sedation by means of midazolam and fentanyl or meperidine was applied. Sphincterotomes and guidewires were used for bilary cannulation. Sometimes, rapid exchange platforms with short-length guidewires controlled by the same endoscopist were employed. Biliary cannulation was confirmed in 9 occasions by bile aspiration. In five procedures, a mean of 30 seconds of fluoroscopy was used, both to verify cannulation and to corroborate complete CBDS clearance. These patients had the pelvic zone protected with a lead shield and radiation dose was measured. Ten biliary sphincterotomies were performed followed by CBDS extraction. Two plastic stents were inserted. Relief of biliary obstruction was attained in all circumstances. Only one patient had hyperamylasemia after ERCP. All pregnant women had healthy foetuses with normal deliveries. CONCLUSIONS: with experience, ERCP appears to be a safe technique during pregnancy. With simple measures fluoroscopic time can be diminished or even abolished. It seems that ERCP during pregnancy is underused in our working areas, although it has shown to be a useful technique for relieving biliary obstruction.

Endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience.

Background and study aims Traditionally in the case of a vascular interposition, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has been contraindicated. A transvascular route (TV) is feasible and probably a safe alternative approach in selected patients, but data are scarce. The primary aim of this study was to analyze the diagnostic yield and safety of EUS-TV-FNA in thoracic and abdominal lesions. Secondary aims included evaluation of the clinical impact and technical aspects. Patients and methods A retrospective multicenter study was conducted with inclusion of all consecutive patients that underwent EUS-TV-FNA from July 2007 to January 2020. Feasibility, cytopathology, procedure details, and safety were evaluated. Univariate analysis was performed to identify variables associated with incidents, cytopathological diagnosis, and clinical impact. Results Data were collected from a total of 49 cases and 50 EUS-TV-FNAs. The aorta (n = 19) and portal system (n = 17) were the most frequently punctured. The most frequent lesions were mediastinal lymph nodes (n = 13) and pancreatic tumors (n = 11). The diagnostic yield was 86 %, and there were nondiagnostic samples in seven cases. Overall sensitivity, specificity, and accuracy were 88 % (95 %CI,0.74-0.96), 100 % (95 %CI,0.59-1), and 90 % (95 %CI,0.78-0.96), respectively. Only three incidents were detected: two mural hematomas and a self-limited bleeding of gastroduodenal artery. In most patients, there was a significant impact on clinical management (88 %). Arterial vessel and ASA-III had a trend with incidents (both, P  < 0.08). Rapid on-site evlauation was found to be an independent predictor for obtaining a conclusive sample (OR 6.2; 95 %CI, 1.06-36.73, P  < 0.04). Conclusions EUS-TV-FNA is feasible, seems to be safe, and can be recommended when no other targets are available, and the information obtained would impact on the clinical plan.

Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.

BACKGROUND: It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. METHODS/DESIGN: This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. DISCUSSION: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.

Patient perception and preference of EUS-guided drainage over percutaneous drainage when endoscopic transpapillary biliary drainage fails: An international multicenter survey.

BACKGROUND AND OBJECTIVES: EUS-guided biliary drainage (EUS-BD) is a feasible procedure when ERCP fails, as is percutaneous transhepatic BD (PTBD). However, little is known about patient perception and preference of EUS-BD and PTBD. PATIENTS AND METHODS: An international multicenter survey was conducted in seven tertiary referral centers. In total, 327 patients, scheduled to undergo ERCP for suspected malignant biliary obstruction, were enrolled in the study. Patients received decision aids with visual representation regarding the techniques, benefits, and adverse events (AEs) of EUS-BD and PTBD. Patients were then asked the choice between the two simulated scenarios (EUS-BD or PTBD) after failed ERCP, the reasons for their preference, and whether altering AE rates would influence their prior choice. RESULTS: In total, 313 patients (95.7%) responded to the questionnaire and 251 patients (80.2%) preferred EUS-BD. The preference of EUS-BD was 85.7% (186/217) with EUS-BD expertise, compared to 67.7% (65/96) without EUS-BD expertise (P < 0.001). The main reason for choosing EUS-BD was the possibility of internal drainage (78.1%). In multivariate analysis, the availability of EUS-BD expertise was the single independent factor that influenced patient preference (odds ratio: 3.168; 95% of confidence interval, 1.714-5.856; P < 0.001). The preference of EUS-BD increased as AE rates decreased (P < 0.001). CONCLUSIONS: In this simulated scenario, approximately 80% of patients preferred EUS-BD over PTBD after failed ERCP. However, preference of EUS-BD declined as its AE rates increased. Further technical innovations and improved proficiency in EUS-BD for reducing AEs may encourage the use of this procedure as a routine clinical practice when ERCP fails.

Advice from a medical expert through the Internet on queries about AIDS and hepatitis: analysis of a pilot experiment.

BACKGROUND: Advice from a medical expert on concerns and queries expressed anonymously through the Internet by patients and later posted on the Web, offers a new type of patient-doctor relationship. The aim of the current study was to perform a descriptive analysis of questions about AIDS and hepatitis made to an infectious disease expert and sent through the Internet to a consumer-oriented Web site in the Spanish language. METHODS AND FINDINGS: Questions were e-mailed and the questions and answers were posted anonymously in the "expert-advice" section of a Web site focused on AIDS and hepatitis. We performed a descriptive study and a temporal analysis of the questions received in the first 12 months after the launch of the site. A total of 899 questions were received from December 2003 to November 2004, with a marked linear growth pattern. Questions originated in Spain in 68% of cases and 32% came from Latin America (the Caribbean, Central America, and South America). Eighty percent of the senders were male. Most of the questions concerned HIV infection (79%) with many fewer on hepatitis (17%). The highest numbers of questions were submitted just after the weekend (37% of questions were made on Mondays and Tuesdays). Risk factors for contracting HIV infection were the most frequent concern (69%), followed by the window period for detection (12.6%), laboratory results (5.9%), symptoms (4.7%), diagnosis (2.7%), and treatment (2.2%). CONCLUSIONS: Our results confirm a great demand for this type of "ask-the-expert" Internet service, at least for AIDS and hepatitis. Factors such as anonymity, free access, and immediate answers have been key factors in its success.

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience.

BACKGROUND: Surgical gastrojejunostomy and enteral self-expanding metal stents are efficacious for the management of gastric outlet obstruction but limited by high complication rates and short-term efficacy. Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a novel alternative option. PATIENTS AND METHODS: Patients who underwent EUS-GJ between March 2014 and September 2015 as part of a prospective multicenter registry at four academic centers in two countries were included. Technical success was defined as successful placement of a gastrojejunal lumen-apposing metal stent. Clinical success was defined as the ability of the patient to tolerate an oral diet. Post-procedural adverse events were recorded. RESULTS: The study included 26 patients, of whom 11 (42 %) were male. Technical success was achieved in 24 patients (92 %). Clinical success was achieved in 22 patients (85 %). Of the 4 patients in whom clinical success was not achieved, 2 had persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred in 3 patients (11.5 %). CONCLUSION: EUS-GJ is an emerging procedure that has efficacy and safety comparable with those of current therapies and should hold a place as a new minimally invasive option for patients with gastric outlet obstruction. Clinical trial identification number: NCT01522573.

International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time?

BACKGROUND: Cholecystectomy remains the gold standard treatment of cholecystitis. Endoscopic treatment of cholecystitis includes transpapillary gallbladder drainage. Recently, endoscopic ultrasound-guided transmural drainage of the gallbladder (EUS-GBD) has been reported. This study reports the cumulative experience of an international group performing EUS-GBD. METHODS: Cases of EUS-GBD from January 2012 to November 2013 from 3 tertiary-care institutions were captured in a registry. Patient demographics, disease characteristics, procedural and clinical outcomes were recorded. RESULTS: 35 patients (15 malignant, 20 benign) were included. Median age was 81 years (SD=13.76 years), sixteen (46%) were males. Median follow-up was 91.5 days (SD=157 days). Transmural access was obtained from the stomach (n=17) or duodenum (n=18). Stents placed included plastic (n=6), metal (n=20), or combination (n=7). Technical success was achieved in 91.4% (n=32). Immediate adverse events (14%) included: bleeding, stent migration, cholecystitis and hemoperitoneum. Delayed adverse events (11%) included abscess formation and recurrence of cholecystitis. Long-term clinical success rate was 89%. Stent type and puncture site were not associated with immediate (p=0.88, p=0.62), or long-term (p=0.47, p=0.27) success. CONCLUSIONS: EUS-GBD appears to be feasible, safe, and effective. Prospective studies are needed to confirm these findings and identify the best technique to use. CLINICAL TRIAL REGISTRATION: NCT01522573.

International multicenter comparative trial of transluminal EUS-guided biliary drainage via hepatogastrostomy vs. choledochoduodenostomy approaches.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be performed entirely transgastrically (hepatogastrostomy/EUS-HG) or transduodenally (choledochoduodenostomy/EUS-CDS). It is unknown how both techniques compare. The aims of this study were to compare efficacy and safety of both techniques and identify predictors of adverse events. PATIENTS AND METHODS: Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EUS-BD at multiple international centers were included. Technical/clinical success, adverse events, stent complications, and survival were assessed. RESULTS: A total of 121 patients underwent EUS-BD (CDS 60, HG 61). Technical success was achieved in 112 (92.56 %) patients (EUS-CDS 93.3 %, EUS-HG 91.8 %, P = 0.75). Clinical success was attained in 85.5 % of patients who underwent EUS-CDS group as compared to 82.1 % of patients who underwent EUS-HG (P = 0.64). Adverse events occurred more commonly in the EUS-HG group (19.67 % vs. 13.3 %, P = 0.37). Both plastic stenting (OR 4.95, 95 %CI 1.41 - 17.38, P = 0.01) and use of non-coaxial electrocautery (OR 3.95, 95 %CI 1.16 - 13.40, P = 0.03) were independently associated with adverse events. Length of hospital stay was significantly shorter in the CDS group (5.6 days vs. 12.7 days, P < 0.001). Mean follow-up duration was 151 ±â€Š159 days. The 1-year stent patency probability was greater in the EUS-CDS group [0.98 (95 %CI 0.76 - 0.96) vs 0.60 (95 %CI 0.35 - 0.78)] but overall patency was not significantly different. There was no difference in median survival times between the groups (P = 0.36) CONCLUSIONS: Both EUS-CDS and EUS-HG are effective and safe techniques for the treatment of distal biliary obstruction after failed ERCP. However, CDS is associated with shorter hospital stay, improved stent patency, and fewer procedure- and stent-related complications. Metallic stents should be placed whenever feasible and non-coaxial electrocautery should be avoided when possible as plastic stenting and non-coaxial electrocautery were independently associated with occurrence of adverse events.

Utility of noninvasive ventilation in high-risk patients during endoscopic retrograde cholangiopancreatography.

BACKGROUND: There is little evidence on noninvasive ventilation (NIV) preventing respiratory complications in high-risk patients undergoing endoscopy procedures. OBJECTIVES: The objective of this study is to demonstrate that the application of NIV through a nasal interface can prevent the appearance of ventilatory alterations during endoscopic retrograde cholangiopancreatography (ERCP) in patients with risk factors associated with the development of hypoventilation. PATIENTS AND METHODS: A non-randomized interventional study was performed on 37 consecutive high-risk patients undergoing ERCP. During the procedure, 21 patients received oxygen by nasal cannula (3 L/minute) and sixteen received NIV through a nasal mask. Arterial blood gas analyses were conducted before and immediately after the ERCP. An Acute Physiology and Chronic Health Evaluation (APACHE) score pre-ERCP was recorded. The complications during the procedure were recorded. RESULTS: The groups with and without NIV were comparable. A post-ERCP pH of <7.35 was found in eight patients, who did not receive ventilatory support (38.1%) compared to zero patients in the NIV group (P = 0.006). A post-ERCP pCO2 >45 mmHg was found in one case (6.3%) in the NIV-group and in nine cases in the nasal cannula group (42.9%; P = 0.01). The median pCO2 post-ERCP was lower (36.5 ± 6.2 vs. 44.5 ± 6.8 mmHg) (P = 0.001) and median pH post-ERCP was higher (7.41 ± 0.4 vs. 7.34 ± 0.5) (P = 0.001) in patients treated with NIV. In the multivariate analysis, after adjusting for gender, the APACHE score, pH and pCO2 pre-ERCP, age, propofol doses, and procedure duration, the following differences were maintained (pCO2 difference = 5.54, 95% Confidence Interval (CI) =2.3 - 8.7, pH difference = 0.047, and 95% CI = 0.013 - 0.081). Among the 37 procedures, four complications occurred: One in the NIV group and three in the nasal cannula group. None of them was related to NIV. CONCLUSIONS: Our preliminary results demonstrate that in high-risk patients undergoing ERCP, hypercapnia and respiratory acidosis are frequent. NIV prevents the appearance of these complications.

Endosonography-guided cholangiopancreatography as a salvage drainage procedure for obstructed biliary and pancreatic ducts.

Endoscopic ultrasound allows transmural access to the bile or pancreatic ducts and subsequent contrast injection to provide ductal drainage under fluoroscopy using endoscopic retrograde cholangiopancreatography (ERCP)-based techniques. Differing patient specifics and operator techniques result in six possible variant approaches to this procedure, known as endosonography-guided cholangiopancreatography (ESCP). ESCP has been in clinical use for a decade now, with over 300 cases reported. It has become established as a salvage procedure after failed ERCP in the palliation of malignant biliary obstruction. Its role in the management of clinically severe chronic/relapsing pancreatitis remains under scrutiny. This review aims to clarify the concepts underlying the use of ESCP and to provide technical tips and a detailed step-by-step procedural description.