EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Pharmacological and Endoscopic Interventions for Prophylaxis of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

Background: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) represents the most common serious complication after endoscopic retrograde cholangiopancreatography (ERCP). Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stenting (PDS) are the prophylactic interventions with more evidence and efficacy; however, PEP still represents a significant source of morbidity, mortality, and economic burden. Chronic statin use has been proposed as a prophylactic method that could be cheap and relatively safe. However, the evidence is conflicting. We aimed to evaluate the impact of endoscopic and pharmacological interventions including chronic statin and aspirin use, on the development of PEP. Methods: A retrospective cohort study evaluated consecutive patients undergoing ERCP at John H. Stroger, Jr. Hospital of Cook County in Chicago from January 2015 to March 2018. Univariate and multivariate analyses were performed using logistic regression. Results: A total of 681 ERCPs were included in the study. Twelve (1.76%) developed PEP. Univariate, multivariate, and subgroup analyses did not show any association between chronic statin or aspirin use and PEP. PDS and rectal indomethacin were protective in patients undergoing pancreatic duct injection. Pancreatic duct injection, female sex, and younger age were associated with a higher risk. History of papillotomy was associated with lower risk only in the univariate analysis (all P values < 0.05). Conclusion: Chronic use of statins and aspirin appears to add no additional benefit to prevent ERCP pancreatitis. Rectal NSAIDs, and PDS after appropriate patient selection continue to be the main prophylactic measures. The lower incidence at our center compared with the reported data can be explained by the high rates of rectal indomethacin and PDS, the use of noninvasive diagnostic modalities for patient selection, and the expertise of the endoscopists.

Spanish translation and validation of a hybrid, health-related quality of life questionnaire for chronic esophageal conditions: NEQOL-S.

BACKGROUND: Chronic esophageal conditions (CEC) are associated with significant disease-related burden, disability, and costs. Health-related quality of life (HRQOL) constructs are intended to capture the physical, mental, social, and emotional aspects of a patient's life and how health status impacts these domains. The Northwestern Esophageal Quality of Life (NEQOL) can be used among esophageal diseases while maintaining sensitivity to specific conditions. We aimed to translate, cross-cultural adapt, and validate the NEQOL into Spanish. METHODS: After language and cross-cultural adaptation, the NEQOL was applied to an outpatient clinic-based population in a single tertiary center. We analyzed the internal consistency, construct, criterion validity, and test-retest reliability of the questionnaire. The criterion validity was tested against the SF-12 questionnaire. KEY RESULTS: After completing the translation process, no item was considered problematic. A total of 385 patients were included in the validation study. The internal consistency (Cronbach's alpha) for the total NEQOL-S score was 0.89. The NEQOL-S questionnaire showed moderate test-retest reliability (ICC = 0.828; 95% CI 0.755-0.881; p < 0.001). Criterion validity showed good coherence when correlated with the SF-12 survey (R2  = 0.538; 95% CI 0.491-0.585, p < 0.001). CONCLUSIONS AND INFERENCES: The translated and cross-culturally adapted NEQOL-S showed good psychometric properties that allow its use in Spanish-speaking patients suffering from CEC.

Prophylactic EUS-guided gallbladder drainage prevents acute cholecystitis in patients with malignant biliary obstruction and cystic duct orifice involvement: a randomized trial (with video).

BACKGROUND AND AIMS: Patients with distal malignant biliary obstruction (MBO) and cystic duct orifice tumoral involvement have an increased risk for the development of acute cholecystitis after self-expandable metallic stent (SEMS) placement. We aimed to determine whether primary EUS-guided gallbladder drainage prevents acute cholecystitis in these patients. METHODS: This was a single-center, randomized control trial in patients with distal MBO enrolled from July 2018 to July 2020. Patients were randomized into 2 groups: an interventional group treated with conventional ERCP biliary drainage with SEMS placement and subsequent primary EUS-guided gallbladder drainage (EUS-GBD) and a control group treated with conventional biliary drainage alone. The primary outcome of the study was the occurrence of post-treatment acute cholecystitis, assessed for ≤12 months or until death. The secondary outcomes were hospitalization length and median survival time. RESULTS: Forty-four patients were included in the study: 22 in each group. Five patients in the control group (22.7%) and none in the intervention group experienced acute cholecystitis. The median hospitalization time was significantly lower in the interventional group than in the control group (2 days vs 1 day, P = .017). There was no difference in the observed median survival rates in the primary EUS-GBD group (2.9 months) and the control group (2.8 months) (P = .580). CONCLUSION: In this single-center study of patients with unresectable MBO and occlusion of the cystic duct orifice, prophylactic EUS-GBD demonstrated a reduced incidence of acute cholecystitis.

Endoscopic ultrasound elastography for malignant pancreatic masses and associated lymph nodes: Critical evaluation of strain ratio cutoff value.

BACKGROUND: Endoscopic ultrasound (EUS) can detect small lesions throughout the digestive tract; however, it remains challenging to accurately identify malignancies with this approach. EUS elastography measures tissue hardness, by which malignant and nonmalignant pancreatic masses (PMs) and lymph nodes (LNs) can be differentiated. However, there is currently little information regarding the strain ratio (SR) cutoff in Hispanic populations. AIM: To determine the diagnostic accuracy of EUS elastography for PMs and LNs with an SR cutoff value in Hispanics. METHODS: A retrospective study of patients who underwent EUS elastography for PMs between December 2013 and December 2014. A qualitative (analysis of color maps) and quantitative (SR) analysis of PMs and their associated LNs was performed. The accuracy of EUS elastography in identifying malignant PMs and LNs and cutoff value for SR were analyzed. A PM and/or its associated LNs were considered malignant based on histopathological findings from fine-needle aspiration biopsy samples. RESULTS: A sample of 121 patients was included, 45.4% of whom were female. 69 (57.0%) PMs were histologically malignant, with a median SR of 50.4 vs 33.0 for malignant vs nonmalignant masses (P < 0.001). EUS evaluation identified associated LNs in 43/121 patients (35.5%), in whom 22/43 (51.2%) patients had histologically confirmed malignant diagnosis, with a median SR of 30 vs 40 for malignant vs nonmalignant LNs (P = 0.7182). In detecting malignancy in PMs, an SR cutoff value of > 21.5 yielded a sensitivity of 94.2%, while a cutoff value of > 121 yielded a specificity of 96.2.2%. There were significant differences in the Giovannini scores, a previously established elastic score system, between the patients grouped by their final histology results (P < 0.001). For LNs, SR cutoff values of > 14.0 and > 155 yielded a sensitivity of 90.9% and a specificity of 95.2%, respectively, in detecting malignancy. CONCLUSION: EUS elastography is a helpful technique for the diagnosis of solid PMs and their associated LNs. The proposed SR cutoff values have a high sensitivity and specificity for the detection of malignancy.

New technologies for indeterminate biliary strictures.

An early and accurate diagnosis of biliary strictures yields optimal patient outcomes; however, endoscopic retrograde cholangiopancreatography (ERCP) with cytobrush/biopsy forceps has low sensitivity with a high number of false negatives. Various attempts to improve the accuracy of diagnosing indeterminate biliary strictures though ERCP-guided specimen acquisition have been proposed, such as with the use of fluorescence in situ hybridization, an endoscopic scraper, and the wire-grasping method, with modest to large improvements in sensitivity. Direct visualization of the biliary tree during peroral cholangioscopy has shown high sensitivity and specificity for the differentiation of neoplastic and non-neoplastic biliary lesions; however, there is no consensus on the visual characteristics of neoplastic lesions and moderate agreement between observers. Peroral cholangioscopy system (POCS)-guided specimen acquisition using forceps has shown inferior sensitivity compared to the visual characteristics; however, the specificity remains high. Optimal specimen processing with onsite evaluations and touch imprint cytology have been shown to improve the sensitivity and accurately diagnose nearly 90% of patients. In vivo evaluations of biliary strictures with probe-based confocal laser endomicroscopy have demonstrated high sensitivity with modest specificity for malignant biliary strictures. Optical computed tomography described reproductible criteria for malignancy detection in biliary strictures, increasing the sensitivity during ERCP evaluations. Differentiating benign causes from malignant causes of biliary strictures is a challenging task in clinical practice, with various concerns that still need to be addressed. Efforts should be made to define each diagnostic method's role in the evaluation of indeterminate biliary strictures.

Newly proposed quantitative criteria can assess chronic atrophic gastritis via probe-based confocal laser endomicroscopy (pCLE): a pilot study.

Background and study aims Probe-based confocal laser endomicroscopy (pCLE) can provide high magnification to evaluate chronic atrophic gastritis (CAG), but the current pCLE criteria are qualitative and prone to variability. We aimed to propose a quantitative CAG criterion based on pCLE to distinguish non-atrophic gastritis (NAG) from CAG. Patients and methods This observational, exploratory pilot study included patients with NAG and CAG evaluated via esophagogastroduodenoscopy, pCLE, and histology. We measured the gastric glands density, gastric gland area, and inter-glandular distance during pCLE. Results Thirty-nine patients (30/39 with CAG) were included. In total, 194 glands were measured by pCLE, and 18301 were measured by histology, with a median of five glands per NAG patient and 4.5 per CAG patient; pCLE moderately correlate with histology (rho = 0.307; P  = 0.087). A gland area of 1890-9105 µm 2 and an inter-glandular distance of 12 to 72 µm based on the values observed in the NAG patients were considered normal. The proposed pCLE-based CAG criteria were as follows: a) glands density < 5; b) gland area < 1/16 the pCLE field area (< 1890 µm 2 ) or > 1/4 the pCLE field area (> 9105 µm 2 ); or c) inter-glandular distance < 12 or > 72 µm; CAG was diagnosed by the presence of at least one criterion. The proposed criteria discriminated CAG with a ranged sensitivity of 76.9 % to 92.3 %, a negative predictive value of 66.6 % to 80.0 %, and 69.6 % to 73.9% accuracy. Conclusions The proposed pCLE criteria offer an accurate quantitative measurement of CAG with high sensitivity and excellent interobserver agreement. Larger studies are needed to validate the proposed criteria.

Endoscopic ultrasound-guided through-the-needle microforceps biopsy and needle-based confocal laser-endomicroscopy increase detection of potentially malignant pancreatic cystic lesions: A single-center study.

BACKGROUND: Currently, there is insufficient data about the accuracy in the diagnosing of pancreatic cystic lesions (PCLs), especially with novel endoscopic techniques such as with direct intracystic micro-forceps biopsy (mFB) and needle-based confocal laser-endomicroscopy (nCLE). AIM: To compare the accuracy of endoscopic ultrasound (EUS) and associated techniques for the detection of potentially malignant PCLs: EUS-guided fine needle aspiration (EUS-FNA), contrast-enhanced EUS (CE-EUS), EUS-guided fiberoptic probe cystoscopy (cystoscopy), mFB, and nCLE. METHODS: This was a single-center, retrospective study. We identified patients who had undergone EUS, with or without additional diagnostic techniques, and had been diagnosed with PCLs. We determined agreement among malignancy after 24-mo follow-up findings with detection of potentially malignant PCLs via the EUS-guided techniques and/or EUS-guided biopsy when available (EUS malignancy detection). RESULTS: A total of 129 patients were included, with EUS performed alone in 47/129. In 82/129 patients, EUS procedures were performed with additional EUS-FNA (21/82), CE-EUS (20/82), cystoscopy (27/82), mFB (36/82), nCLE (44/82). Agreement between EUS malignancy detection and the 24-mo follow-up findings was higher when associated with additional diagnostic techniques than EUS alone [62/82 (75.6%) vs 8/47 (17%); OR 4.35, 95%CI: 2.70-7.37; P < 0.001]. The highest malignancy detection accuracy was reached when nCLE and direct intracystic mFB were both performed, with a sensitivity, specificity, positive predictive value, negative predictive value and observed agreement of 100%, 89.4%, 77.8%, 100% and 92.3%, respectively (P < 0.001 compared with EUS-alone). CONCLUSION: The combined use of EUS-guided mFB and nCLE improves detection of potentially malignant PCLs compared with EUS-alone, EUS-FNA, CE-EUS or cystoscopy.

Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor.

Video 1EUS-guided microwave ablation of an unresectable pancreatic mass using a novel generator platform and a specialized 19.5-gauge needle antenna.

Artificial Intelligence in the Diagnosis of Upper Gastrointestinal Diseases.

Artificial intelligence (AI) has enormous potential to support clinical routine workflows and therefore is gaining increasing popularity among medical professionals. In the field of gastroenterology, investigations on AI and computer-aided diagnosis (CAD) systems have mainly focused on the lower gastrointestinal (GI) tract. However, numerous CAD tools have been tested also in upper GI disorders showing encouraging results. The main application of AI in the upper GI tract is endoscopy; however, the need to analyze increasing loads of numerical and categorical data in short times has pushed researchers to investigate applications of AI systems in other upper GI settings, including gastroesophageal reflux disease, eosinophilic esophagitis, and motility disorders. AI and CAD systems will be increasingly incorporated into daily clinical practice in the coming years, thus at least basic notions will be soon required among physicians. For noninsiders, the working principles and potential of AI may be as fascinating as obscure. Accordingly, we reviewed systematic reviews, meta-analyses, randomized controlled trials, and original research articles regarding the performance of AI in the diagnosis of both malignant and benign esophageal and gastric diseases, also discussing essential characteristics of AI.

Endoscopic Treatment of Gastric and Ectopic Varices.

Gastric variceal bleeding has a high mortality. Endoscopic cyanoacrylate injection is the standard therapy; however, rebleeding and unexpected adverse events, such as injection sites ulcers and distal glue embolisms, are pitfalls of this therapy. Endoscopic ultrasound (EUS)-guided endovascular therapies offer a safer and more practical alternative for the treatment of gastric varices. EUS-guided combined therapy with coiling and cyanoacrylate injection is the most promising alternative with high obliteration rates and fewer adverse events reported. The authors reviewed the latest available data for all endoscopic therapies proposed for the management of gastric varices in patients with chronic liver disease.

Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video).

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.).

Novel 15-mm-long lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections located ≥10 mm from the luminal wall.

BACKGROUND: Endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) by cautery-enhanced lumen-apposing metal stents (LAMS) has largely been limited to collections located < 10 mm from the luminal wall. We present outcomes of the use of a novel 15-mm-long cautery-enhanced LAMS for drainage of PFCs located ≥ 10 mm away. METHODS: This international, multicenter study analyzed all adults with PFCs located ≥ 10 mm from the luminal wall who were treated by EUS-guided drainage using the 15-mm-long cautery-enhanced LAMS. The primary outcome was technical success. Secondary outcomes included clinical success (decrease in PFC size by ≥ 50 % at 30 days and resolution of clinical symptoms without surgical intervention), complications, and recurrence. RESULTS: 35 patients (median age 57 years; interquartile range [IQR] 47-64 years; 49 % male) underwent novel LAMS placement for drainage of PFCs (26 walled-off necrosis, 9 pseudocysts), measuring 85 mm (IQR 64-117) maximal diameter and located 11.8 mm (IQR 10-12.3; range 10-14) from the gastric/duodenal wall. Technical and clinical success were high (both 97 %), with recurrence in one patient (3 %) at a median follow-up of 123 days (58-236). Three complications occurred (9 %; one mild, two moderate). CONCLUSIONS: The 15-mm-long cautery-enhanced LAMS was feasible and safe for drainage of PFCs located 10-14 mm from the luminal wall.

Per Oral Endoscopic Myotomy for Zenker's Diverticulum: A Novel and Superior Technique Compared With Septotomy?

INTRODUCTION: Endoscopic management of Zenker diverticuli (ZD) has traditionally been via septotomy technique. The recent development of tunneling technique has shown to be both efficacious and safe. The aim of this study is to evaluate the tunneling technique using per oral endoscopic myotomy (Z-POEM) versus septotomy. METHODS: Patients who underwent endoscopic management of ZD either by Z-POEM or septotomy from March 2017 until November 2020 from 9 international academic centers were included. Demographics, clinical data preprocedure and postprocedure, procedure time, adverse events, and hospital length of stay were analyzed. RESULTS: A total of 101 patients (mean age 74.9 y old, 55.4% male) were included: septotomy (n=49), Z-POEM (n=52). Preprocedure Functional Oral Intake Scale score and Eckardt score was 5.3 and 5.4 for the septotomy group and 5.9 and 5.15 for the Z-POEM group. Technical success was achieved in 98% of the Z-POEM group and 100% of the septotomy group. Clinical success was achieved in 84% and 92% in the septotomy versus Z-POEM groups. Adverse events occurred in 30.6% (n=15) in septotomy group versus 9.6% (n=5) in the Z-POEM group (P=0.017). Reintervention for ongoing symptoms occurred in 7 patients in the septotomy group and 3 patients in the Z-POEM group. Mean hospital length of stay was shorter for the Z-POEM group, at 1.5 versus 1.9 days. CONCLUSIONS: A tunneling technique via the Z-POEM procedure is an efficacious and safe endoscopic treatment for ZD. Z-POEM is a safer procedure with a statistically significant reduction in adverse events compared with traditional septotomy technique.

Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video).

BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.

Lumen-apposing metal stent through the meshes of duodenal metal stents for palliation of malignant jaundice.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard procedure for malignant jaundice palliation; however, it can be challenging when a duodenal self-expandable metal stent (SEMS) is already in place. Patients and methods The primary aim of our study was to evaluate the technical feasibility of the placement of a lumen apposing metal stent (LAMS) through the mesh (TTM) of duodenal stents. The secondary aims were to evaluate clinical outcomes and adverse events (AEs) related to the procedures. Results Data from 23 patients (11 F and 12 M; mean age: 69.5 ±â€Š11 years old) were collected. In 17 patients (73.9 %) TTM LAMS placement was performed as first intention, while in six patients (26.1 %) it was performed after a failed ERCP. Thirteen patients (56.5 %) underwent the procedure due to advanced pancreatic head neoplasia. One technical failure was experienced (4.3 %). The TTM LAMS placement led to a significant decrease in the serum levels of bilirubin, ALP, GGT, WBC and CRP. No cases of duodenal SEMS occlusion occurred and no other AEs were observed during the follow-up. Conclusions Concomitant malignant duodenal and biliary obstruction is a challenging condition. Palliation of jaundice using TTM LAMS in patients already treated with duodenal stent is associated to promising technical and clinical outcomes.