Assessing Endoscopic Ultrasound-Guided Radiofrequency Ablation in Unresectable Pancreatic Ductal Adenocarcinoma: A Single-Center Historic Cohort Study.

BACKGROUND: /aims: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has emerged as an alternative for the local treatment of unresectable pancreatic ductal adenocarcinoma (PDAC). We aim to assess the feasibility and safety of EUS-RFA in patients with unresectable PDAC. METHODS: The following was a historic cohort compounded by locally advanced (LA) and metastatic (m) PDAC naïve patients, who underwent EUS-RFA between October 2019 to March 2022. EUS-RFA was performed with a 19-g needle electrode with a 10 mm active tip for energy delivery. Study primary endpoints were feasibility, safety, and clinical follow-up; secondary endpoints were performance status (PS), local control (LC) and overall survival (OS). RESULTS: Twenty-six patients were selected: 15/26 LA-PDAC and 11/26 mPDAC. Technical success was achieved in all patients with no major adverse events. Six months after EUS-RFA, OS was 11/26 (42.3%), with significant PS improvement (P=.03). LC was achieved, with tumor reduction from 39.5 to 26 mm (P=.04). Post-treatment hypodense necrotic area was observed at six-month follow-up in 11/11 alive cases. Metastatic disease was a significant factor for OS worsening (HR 5.021; IC 95% 1.589 - 15.87; P=.004) CONCLUSIONS: EUS-RFA of pancreatic adenocarcinoma is a minimally invasive and safe technique that may have an important role as targeted therapy for local treatment of unresectable cases, as well as an alternative for poor surgical candidates. Also, RFA may play a role in downstaging cancer with potential OS increase in non-metastatic cases. Large prospective cohorts are required to evaluate this technique in clinical practice.

Latin American consensus on diagnosis of gastroesophageal reflux disease.

BACKGROUND: Diagnosing gastroesophageal reflux disease (GERD) can be challenging given varying symptom presentations, and complex multifactorial pathophysiology. The gold standard for GERD diagnosis is esophageal acid exposure time (AET) measured by pH-metry. A variety of additional diagnostic tools are available. The goal of this consensus was to assess the individual merits of GERD diagnostic tools based on current evidence, and provide consensus recommendations following discussion and voting by experts. METHODS: This consensus was developed by 15 experts from nine countries, based on a systematic search of the literature, using GRADE (grading of recommendations, assessment, development and evaluation) methodology to assess the quality and strength of the evidence, and provide recommendations regarding the diagnostic utility of different GERD diagnosis tools, using AET as the reference standard. KEY RESULTS: A proton pump inhibitor (PPI) trial is appropriate for patients with heartburn and no alarm symptoms, but nor for patients with regurgitation, chest pain, or extraesophageal presentations. Severe erosive esophagitis and abnormal reflux monitoring off PPI are clearly indicative of GERD. Esophagram, esophageal biopsies, laryngoscopy, and pharyngeal pH monitoring are not recommended to diagnose GERD. Patients with PPI-refractory symptoms and normal endoscopy require reflux monitoring by pH or pH-impedance to confirm or exclude GERD, and identify treatment failure mechanisms. GERD confounders need to be considered in some patients, pH-impedance can identify supragrastric belching, impedance-manometry can diagnose rumination. CONCLUSIONS: Erosive esophagitis on endoscopy and abnormal pH or pH-impedance monitoring are the most appropriate methods to establish a diagnosis of GERD. Other tools may add useful complementary information.

Development of convolutional neural network models that recognize normal anatomic structures during real-time radial-array and linear-array EUS (with videos).

BACKGROUND AND AIMS: EUS is a high-skill technique that requires numerous procedures to achieve competence. However, training facilities are limited worldwide. Convolutional neural network (CNN) models have been previously implemented for object detection. We developed 2 EUS-based CNN models for normal anatomic structure recognition during real-time linear- and radial-array EUS evaluations. METHODS: The study was performed from February 2020 to June 2022. Consecutive patient videos of linear- and radial-array EUS videos were recorded. Expert endosonographers identified and labeled 20 normal anatomic structures within the videos for training and validation of the CNN models. Initial CNN models (CNNv1) were developed from 45 videos and the improved models (CNNv2) from an additional 102 videos. CNN model performance was compared with that of 2 expert endosonographers. RESULTS: CNNv1 used 45,034 linear-array EUS frames and 21,063 radial-array EUS frames. CNNv2 used 148,980 linear-array EUS frames and 128,871 radial-array EUS frames. Linear-array CNNv1 and radial-array CNNv1 achieved a 75.65% and 71.36% mean average precision (mAP) with a total loss of .19 and .18, respectively. Linear-array CNNv2 obtained an 88.7% mAP with a .06 total loss, whereas radial-array CNNv2 achieved an 83.5% mAP with a .07 total loss. CNNv2 accurately detected all studied normal anatomic structures with a >98% observed agreement during clinical validation. CONCLUSIONS: The proposed CNN models accurately recognize the normal anatomic structures in prerecorded videos and real-time EUS. Prospective trials are needed to evaluate the impact of these models on the learning curves of EUS trainees.

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.

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.

Cost-effectiveness of endoscopic ultrasound-guided coils plus cyanoacrylate injection compared to endoscopic cyanoacrylate injection in the management of gastric varices.

BACKGROUND: Cyanoacrylate (CYA) injection can be performed using a standard upper endoscopy technique or under endoscopic ultrasound (EUS) guidance alone or in combination with coils. There is little information available on the economic impact of these treatment methods. AIM: To compare the cost-effectiveness of treating gastric varices by CYA injection via upper endoscopy vs coils plus CYA guided by EUS. METHODS: This was an observational, descriptive, and retrospective study. Patients were allocated into two groups: A CYA group and coils plus CYA group. The baseline characteristics were compared, and a cost analysis was performed. RESULTS: Overall, 36 patients were included (19 in the CYA group and 17 in the coils + CYA group). All patients in the CYA group had acute bleeding. They underwent a higher mean number of procedures (1.47 vs 1, P = 0.025), and the mean volume of glue used was 2.15 vs 1.65 mL, P = 0.133. The coils + CYA group showed a higher technical success rate (100% vs 84.2%), with a complication rate similar to the CYA group. The majority of CYA patients required hospitalization, and although the mean total per procedure cost was lower (United States $ 1350.29 vs United States $ 2978), the mean total treatment cost was significantly different (United States $ 11060.89 for CYA vs United States $ 3007.13 for coils + CYA, P = 0.03). CONCLUSION: The use of EUS-guided coils plus cyanoacrylate is more cost-effective than cyanoacrylate injection when the total costs are evaluated. Larger, randomized trials are needed to validate the cost-effectiveness of the EUS-guided approach to treat gastric varices.

Vascularity can distinguish neoplastic from non-neoplastic bile duct lesions during digital single-operator cholangioscopy.

BACKGROUND AND AIMS: Various macroscopic features are proposed for the diagnosis of biliary lesions during digital single-operator cholangioscopy (DSOC); however, neovasculature may be one of the most reliable features of neoplasia. We aimed to evaluate the detection of neovasculature during DSOC to distinguish neoplastic from non-neoplastic bile duct lesions. METHODS: A retrospective, single-center, cohort study was used. Neovasculature was defined as the presence of irregular or "spider" vascularity on bile duct lesions. The accuracy of detection of neovasculature for the identification of neoplastic lesions was estimated using the histologic results, surgical specimens, and/or 6-month follow-up as the criterion standard. Interobserver agreement analysis (kappa value) was performed between 2 expert endoscopists and 3 nonexpert physicians. RESULTS: Ninety-five patients were included; the median age was 65.6 years (range, 20-93 years), and 51 (53.7%) patients were female. Signs of neovasculature were observed in 65 of 95 (68.4%) patients. Histology confirmed neoplasia in 48 of 95 (50.5%) patients, and 6-month follow-up survival confirmed neoplasia in 52 of 95 (54.7%) patients. The use of vascularity for identifying neoplastic lesions achieved an accuracy of 80%, sensitivity of 94%, specificity of 63%, positive predictive value of 75%, negative predictive value of 90%, positive likelihood ratio of 2.53 (95% confidence interval, 1.71-3.76), and negative likelihood ratio of 0.09 (95% confidence interval, 0.03-0.28). The interobserver and intraobserver agreement were excellent (κ > 80%; P < .001) between expert endoscopists and nonexpert physicians. CONCLUSION: Detection of irregular or spider vascularity on bile duct lesions during DSOC evaluations accurately identifies biliary neoplastic lesions. Prospective multicenter trials are required to evaluate neovasculature as a single factor for predicting neoplasia.

Over-The-Scope Clip system as a first-line therapy for high-risk bleeding peptic ulcers: a retrospective study.

BACKGROUND: Effective hemostasis is essential to prevent rebleeding. We evaluated the efficacy and feasibility of the Over-The-Scope Clip (OTSC) system compared to combined therapy (through-the-scope clips with epinephrine injection) as a first-line endoscopic treatment for high-risk bleeding peptic ulcers. METHODS: We retrospectively analyzed data of 95 patients from a single, tertiary center and underwent either OTSC (n = 46) or combined therapy (n = 49). The primary outcome of the present study was the efficacy of the OTSC system as a first-line therapy in patients with high-risk bleeding peptic ulcers compared to combined therapy with TTS clips and epinephrine injection. The secondary outcomes included the rebleeding rate, perforation rate, mean procedure time, reintervention rate, mean procedure cost and days of hospitalization in the two study groups within 30 days of the index procedure. RESULTS: All patients achieved hemostasis within the procedure; two patients in the OTSC group and four patients in the combined therapy group developed rebleeding (p = 0.444). No patients experienced gastrointestinal perforation. OTSC had a shorter median procedure time than combined therapy (11 min versus 20 min; p < 0.001). The procedure cost was superior for OTSC compared to combined therapy ($102,000 versus $101,000; p < 0.001). We found no significant difference in the rebleeding prevention rate (95.6% versus 91.8%, p = 0.678), hospitalization days (3 days versus 4 days; p = 0.215), and hospitalization costs ($108,000 versus $240,000, p = 0.215) of the OTSC group compared to the combined therapy group. CONCLUSION: OTSC treatment is an effective and feasible first-line therapy for high-risk bleeding peptic ulcers. OTSC confers comparable costs and patient outcomes as combined treatments, with a shorter procedure time.

Results of liver and spleen endoscopic ultrasonographic elastography predict portal hypertension secondary to chronic liver disease.

Background and study aims Assessment of endoscopic ultrasonography (EUS)-elastography of the liver and spleen may identify patients with portal hypertension secondary to chronic liver disease. We aimed to evaluate use of EUS-elastography of the liver and spleen in identification of portal hypertension in patients with chronic liver disease. Patients and methods This was a single-center, diagnostic cohort study. Consecutive patients with liver cirrhosis and portal hypertension underwent EUS-elastography of the liver and spleen. Patients without a history of liver disease were enrolled as controls. The primary outcome was diagnostic yield of liver and spleen stiffness measurement via EUS-elastography in prediction of portal hypertension secondary to chronic liver cirrhosis. Cutoff values were defined through Youden's index. Overall accuracy was calculated for parameters with an area under the receiver operating characteristic (AUROC) curve ≥ 80 %. Results Among the 61 patients included, 32 had cirrhosis of the liver. Liver and spleen stiffness was measured by the strain ratio and strain histogram, with sensitivity/(1 - specificity) AUROC values ≥ 80 %. For identification of patients with cirrhosis and portal hypertension, the liver strain ratio (SR) had a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 84.3 %, 82.8 %, 84.4 %, and 82.8 %, respectively; the liver strain histogram (SH) had values of 87.5 %, 69.0 %, 75.7 %, and 83.3 %, respectively. EUS elastography of the spleen via the SR reached a sensitivity, specificity, PPV, and NPV of 87.5 %, 69.0 %, 75.7 %, and 83.3 %, respectively, whereas the values of SH were 56.3 %, 89.7 %, 85.7 %, and 65.0 %, respectively. Conclusion Endoscopic ultrasonographic elastography of the liver and spleen is useful for diagnosis of portal hypertension in patients with cirrhosis.

Digital per-oral cholangioscopy to diagnose and manage biliary duct disorders: a single-center retrospective study.

Background and study aims Digital, per-oral cholangioscopy (POCS) allows diagnosis of biliary ducts disorders and treatment for complicated stones. We aimed to determine the diagnostic accuracy of digital POCS systems for stricture lesions and the factors precluding complete biliary stone clearance. Patients and methods We performed a retrospective analysis of a prospective database of 265 consecutive patients referred for POCS between December 2016 and July 2018. We first analyzed the diagnostic accuracy of digital POCS for malignant and benign stricture lesions in 147 patients. Then, we analyzed the factors associated with complete or partial biliary stone clearance achieved with electrohydraulic lithotripsy (EHL) delivered via POCS in 118 patients. Results In the diagnostic group, digital POCS achieved 91 % visual-impression sensitivity, 99 % specificity, 99 % positive and 91 % negative predictive values, and 63.64 positive and 0.09 negative likelihood ratios for malignancy diagnosis. In the therapeutic group, complete biliary stone clearance was achieved by EHL in 94.9 % patients; the mean stone size was 20 mm (10-40 mm). In multivariable analyses, a stone size > 20 mm (OR: 1.020, P  < 0.001) and the number of stones ≥ 3 (OR: 1.276, P  < 001) was associated with partial biliary stone clearance. Adverse events were reported in 3.3 % patients; no deaths were reported 30 days after the procedure. Conclusions Digital POCS has excellent diagnostic efficacy for biliary lesions. EHL via POCS is effective for complicated biliary stone clearance. Stone size (> 20 mm) and the number of stones (≥ 3) are associated with partial biliary stone clearance.

Confocal laser endomicroscopy detects colonic inflammation in patients with irritable bowel syndrome: a prospective study.

Background and aims Irritable bowel syndrome (IBS) is considered to be a functional disease, but recent data indicate measurable organic alterations. We aimed to determine the presence of colorectal mucosa microinflammation in vivo via probe-confocal laser endomicroscopy (pCLE) and histological evaluation in IBS patients. Methods This was a prospective, controlled, nonrandomized single-blind diagnostic trial performed in a tertiary institution. pCLE images and targeted biopsy of each colon segment obtained during colonoscopies of IBS patients and controls were analyzed for inflammatory changes. Biopsies were classified using the Geboes scale, and the odds ratio and overall diagnostic accuracy were calculated. Results During the 15-month study period, 37 patients were allocated to each group. The mean age was 53.1 ±â€Š14.3 years; 64.9 % were female. Signs of colonic mucosa inflammation were evident on 65.8 % of pCLE images from IBS patients compared to 23.4 % of images from controls (OR 6.28; 4.14-9.52; P  < 0.001). In total, 20/37 patients had microinflammation via pCLE in ≥ 3 colon segments in the IBS group, compared to 1/37 in the control group. A Geboes score > 0 was attributed to 60.8 % of biopsies from patients in the IBS group compared to 27.5 % of biopsies from the control group. The sensitivity, specificity, positive and negative predictive values, observed and interrater agreement of pCLE-detected inflammatory changes in IBS using histology as gold standard were 76 %, 91 %, 76 %, 91 %, 86.5 %, and 66.8 %, respectively. Conclusions Patients with IBS have a six-fold higher prevalence of colorectal mucosa microinflammation than healthy controls. pCLE might be a reliable method to detect colorectal mucosa microinflammation in IBS patients.