Endoscopic Ultrasound Procedures Research Articles

Contrast-enhanced guided endoscopic ultrasound procedures

Contrast-enhanced endoscopic ultrasound (CH-EUS) can overcome the limitations of endoscopic ultrasound-guided acquisition by identifying microvessels inside inhomogeneous tumours and improving the characterization of these tumours. Despite the initial enthusiasm that oriented needle sampling under CH-EUS guidance could provide better diagnostic yield in pancreatic solid lesions, further studies did not confirm the supplementary values in cases of tissue acquisition guided by CH-EUS. This review details the knowledge based on the available data on contrast-guided procedures. The indications for CH-EUS tissue acquisition include isoechoic EUS lesions with poor visible delineation where CH-EUS can differentiate the lesion vascularisation from the surrounding parenchyma and also the mural nodules within biliopancreatic cystic lesions, which occur in select cases. Additionally, the roles of CH-EUS-guided therapy in patients whose pancreatic fluid collections or bile ducts that have an echogenic content have indications for drainage, and patients who have nonvisualized vessels that need to be highlighted via Doppler EUS are presented. Another indication is represented if there is a need for an immediate assessment of the post-radiofrequency ablation of pancreatic neuroendocrine tumours, in which case CH-EUS can be used to reveal the incomplete tumour destruction.

Same-session endoscopic diagnosis and symptom palliation in pancreato-biliary malignancies: Clinical impact of rapid on-site evaluation (ROSE).

Background and study aims Besides increasing adequacy, rapid on-site evaluation (ROSE) during endoscopic ultrasound (EUS) or endoscopic retrograde cholangiopancreatography (ERCP) may impact choices and timing of subsequent therapeutic procedures, yet has been unexplored. Patients and methods This was a retrospective evaluation of a prospectively maintained database of a tertiary, academic centre with availability of ROSE and hybrid EUS-ERCP suites. All consecutive patients referred for pathological confirmation of suspected malignancy and jaundice or gastric outlet obstruction (GOO) between Jan-2020 and Sep-2022 were included. Results Of 541 patients with underlying malignancy, 323 (59.7%) required same-session pathological diagnosis (male: 54.8%; age 70 [interquartile range 63-78]; pancreatic cancer: 76.8%, biliary tract adenocarcinoma 16.1%). ROSE adequacy was 96.6%, higher for EUS versus ERCP. Among 302 patients with jaundice, ERCP-guided stenting was successful in 83.1%, but final drainage was completed in 97.4% thanks to 43 EUS-guided biliary drainage procedures. Twenty-one patients with GOO were treated with 15 EUS-gastroenterostomies and six duodenal stents. All 58 therapeutic EUS procedures occurred after adequate ROSE. With ERCP-guided placement of stents, the use of plastic stents was significantly higher among patients with inadequate ROSE (10/11; 90.9%) versus adequate sampling (14/240; 5.8%) P <0.0001; OR 161; 95%CI 19-1352). Median hospital stay for diagnosis and palliation was 3 days (range, 2-7) and median time to chemotherapy was 33 days (range, 24-47). Conclusions Nearly two-thirds of oncological candidates for endoscopic palliation require contemporary pathological diagnosis. ROSE adequacy allows, since the index procedure, state-of-the-art therapeutics standardly restricted to pathologically confirmed malignancies (e.g. uncovered SEMS or therapeutic EUS), potentially reducing hospitalization and time to oncological treatments.

Pancreatic biopsy evaluation with nsCanary: A “smart ROSE” device for feedback on sample adequacy and cancer presence in endoscopic biopsies—Initial human clinical trial results.

618 Background: Pancreatic cancer (PC) accounts for 0.5 million new cases and 4.7% of the world's cancer-related deaths in 2020. Endoscopic ultrasound (EUS) guided fine needle biopsies (FNB) are the current standard of care for confirming suspicious lesions, however the diagnostic accuracy is reported below 70%. Rapid on-site evaluation (ROSE) improves the diagnostic performances of biopsies to reduce the number of needle passes, complication rates, and the need for additional procedures. However, availability of an on-site pathologist is often not feasible. NovaScan has pioneered the use of an impedance spectroscopy biomarker for cancer detection in different tissues based on the Cole Relaxation Frequency (CRF). NovaScan has developed the nsCanary, a ”smart ROSE” device that assesses PC presence in FNBs obtained during endoscopic procedures ex vivo, in real-time and on-site, without altering the tissue sample or affecting the workflow. Methods: Data were collected in a double-blind, IRB approved study from a cohort of 53 patients (28 males, 25 females) undergoing EUS procedures for suspected pancreatic lesions at the Texas International Endoscopy Center. FNBs were performed with a 22 gauge biopsy from a transduodenal approach. Each biopsy sample was transferred onto a disposable strainer allowing for any excess fluid to drain. An electrode for scanning was placed onto the core samples for data collection with the nsCanary a low cost, portable device used in the operating room. CRF is measured in the 1 kHz - 10 MHz frequency range via custom-designed hardware and assessment of the sample is completed in a few seconds. Subsequently, the sample is flushed into a pathology jar to undergo the standard workflow for cytology. The algorithm for extracting the CRF from the measurement was developed based on our previous preclinical study with transgenic KPC mice Samples with a CRF below 1 MHz were considered noncancerous, while CRF values above 1MHz or the absence of a CRF reading were considered cancerous. Results: PC assessment provided by nsCanary was validated against pathology outcomes for each biopsy sample. Findings showing a sensitivity of 86.7% and a specificity of 84.2% are reported in the table. Conclusions: We believe the nsCanary device will provide immediate feedback to the endoscopist on cancer presence and on the adequacy of the sample. This device is intended to support the decision-making process, by enabling clinicians to overcome the challenge of proving cancer presence during the first biopsy procedure, ultimately avoiding revisits and unnecessary trauma.[Table: see text]

Abstract B001: Impedance based biomarker for “smart ROSE” pancreatic cancer detection: Initial results from an ongoing clinical trial with nsCanary

Abstract Pancreatic cancer (PC) accounts for half a million new cases and 4.7% of cancer-related deaths globally in 2020. Endoscopic ultrasound (EUS) guided fine needle biopsies (FNB) are the current standard for confirming suspicious lesions, although their diagnostic accuracy remains below 70% with a non-diagnostic rate of the first procedure as high as 40%. Rapid on-site evaluation (ROSE) was introduced to improve diagnostic accuracy via on-site pathology assessment. However, ROSE availability is often limited due to resource constraints. NovaScan has developed the nsCanary, a ”smart ROSE” device, which uses a bioimpedance spectroscopy biomarker based on the Cole Relaxation Frequency (CRF) to detect cancer in biopsy samples in real-time and on-site. The aim of this study is to present initial results from a clinical trial that validates the nsCanary’s ability to detect PC in biopsy samples. Data were collected with the nsCanary device in an IRB approved double-blind study including a cohort of 44 patients (20 males, 24 females; average age of 63 years; 66% White, 22% African American, 12% Hispanic) undergoing EUS procedures with FNB sampling for suspected PC at the Texas International Endoscopy Center in Houston, TX. The nsCanary is a small desktop instrument that performs spectral bioimpedance analysis to extract the CRF based biomarker in less than 30 seconds without altering the biopsied tissue. A touch panel user interface allows for the user to input information and start the measurement. Obtained biopsy samples were flushed in a disposable strainer in order to drain any excess fluid. A circular disposable electrode, consisting of an interdigitated array with alternating polarities was placed in contact with the sample to perform measurements of complex bioimpedance in the 1 kHz - 10 MHz frequency range. The design of the electrode allows it to sense the signal from samples as small as FNB cores. Samples with CRF value below 1 MHz for every scan were considered noncancerous. Samples with at least one CRF value above 1MHz or absence of CRF reading (i.e., CRF out of range) were considered cancerous. PC assessment provided by nsCanary was validated against histopathology outcomes for each biopsy sample. Pathology results indicated that out of the cancerous lesions observed, there were 7 cases of pancreatic adenocarcinoma, 2 cases of invasive adenocarcinoma, 1 case of ductal adenocarcinoma, and 1 case of metastatic renal cell carcinoma. Findings showed a sensitivity of 81.8%, specificity of 84.8%, PPV of 64.3% and NPV of 93.3% for a total of n=44 patients. The device is low cost, portable, and can be used in the surgical suite without interfering with the standard workflow or affecting the sample for following pathological assessment. The implementation of the nsCanary device into the clinic will adjunctively support the decision-making process by providing immediate feedback on cancer detection and sample adequacy. This will enable endoscopists to diagnose PC on the first biopsy procedure, ultimately facilitating prompt treatment of patients. Citation Format: Federica Dibennardo, Martina Guidetti, Onur Fidaner, Daniel S. Gehrke, Donato Ceres, Margaret C. John, Constantine H. Bovalis, Isaac Raijman, Les Bogdanowicz. Impedance based biomarker for “smart ROSE” pancreatic cancer detection: Initial results from an ongoing clinical trial with nsCanary [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Pancreatic Cancer; 2023 Sep 27-30; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(2 Suppl):Abstract nr B001.

Abstract C011: Detection of circulating tumor cells for the early detection of pancreatic cancer

Abstract Introduction The majority of pancreatic cancer patients are diagnosed with advanced, metastatic disease. Biomarkers to detect pancreatic cancer at earlier stages could drastically improve the poor survival rates. Circulating tumor cells (CTCs) are tumor cells that disseminate or are shed into the vascular system and have been detected in patients at pre-malignant stages. However, detecting these rare cells accurately and reliably remains a challenge. The AccuCyte-CyteFinder system uses density-based enrichment of blood nucleated cells followed by detection of CTCs using fluorescence staining, whole slide scanning and automated image analysis. This study aimed to examine whether CTCs could be used to identify patients with pancreatic lesions likely to malignant. Methods 50 patients undergoing an endoscopic ultrasound procedure for a pancreatic mass were recruited at the Royal Prince Alfred Hospital, Sydney, Australia or Chris O’Brien Lifehouse, Sydney, Australia. Peripheral blood was collected prior to the procedure and processed for CTCs on the AccuCyte-CyteFinder platform using a CK+ EpCAM+ CD45- staining panel. Results 28% (14/50) were found to have an intraductal papillary mucinous neoplasm (IPMN), 10% (5/50) pancreatic ductal adenocarcinoma (PDAC), 6% (3/50) pancreatic neuroendocrine tumor (PNET), 42% (21/50) non-neoplastic pancreatic cyst, and 14% (7/50) normal (no mass found). CTCs were highest in the PDAC group with an average of 5 cells/ml, followed by the IPMN (3 cells/ml), pancreatic cyst (2.5 cells/ml), and PNET (0 cells/ml). 86% (12/14) of IPMN patients had detectable CTCs. 2 IPMN patients with CTC counts of more than 5 cells/ml resulted in a resected sample having high-grade dysplasia while 3 IPMN patients with no/low CTC counts resulted in a resected sample having low-grade dysplasia. There was no correlation with the size of the pancreatic mass and CTC number. Conclusions CTCs could be detected in patients with pre-malignant pancreatic cancer and could determine malignancy. CTCs could potentially be used to detect pancreatic cancer early however, larger patient numbers and longer follow-up are required to validate these findings. Citation Format: Dannel Yeo, Vera Klemm, Payal Saxena, Althea Bastian, Heidi Strauss, Charbel Sandroussi, Sara Wahlroos, Peter Grimison, John E.J. Rasko. Detection of circulating tumor cells for the early detection of pancreatic cancer [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Pancreatic Cancer; 2023 Sep 27-30; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(2 Suppl):Abstract nr C011.

The Diagnostic Yield of Endoscopic Ultrasound in Asymptomatic Patients with Unexplained Dilated Common Bile Duct, or Double Duct Sign with Normal Transaminase a Retrospective Study from a Single Urban-based University Endoscopy Center.

Common bile duct dilatation alone or double duct sign (both CBD and dilated pancreatic duct dilatation) and abnormal liver enzymes are highly predictive of biliary disease. This can be identified on ultrasound (US), CT scan, and/or magnetic resonance cholangiopancreatography (MRCP). Unexplained dilatation on imaging might warrant endoscopic ultrasound (EUS) to identify any occult causes. Supporting literature about the importance of using EUS in these conditions is evolving with no clear evidence-based approach to evaluate asymptomatic dilated ducts.We aim to investigate the diagnostic yield of EUS in unexplained CBD dilatation or double duct sign with normal liver enzymes. A retrospective data analysis was conducted from January 2015 to October 2021 on asymptomatic patients with a dilatated CBD of 7 mm or more and 9 mm if the patient had a cholecystectomy history or double duct sign with normal liver enzymes. 32 EUS procedures were indicated for unexplained dilated CBD or double duct sign on imaging with normal liver enzymes. 23 had CBD dilatation alone (72 %), and 9 had a double duct sign (28 %). 20 of the included patients were females (63 %), and 12 were males (37 %), with a mean age of 63.8 ± 17 and 68.2 ± 14 years old, respectively (p = 0.424). The diagnosis after EUS in CBD dilatation alone showed a yield of 56 % as follow; no pathology in 10 (44 %), sludge in 9 patients (39 %), CBD stone in 3 (13 %), malignant stricture in 1 (4 %) (Fig. 1). On the other hand, EUS in those with double duct signs showed a diagnostic yield of 55 %; no pathology in 4 (45 %), pancreatic head adenocarcinoma in 3 patients (33 %), Biliary stone in one patient, and malignant CBD stricture in one patient (11 % each) (Fig. 2). Unexplained CBD dilatation or Double duct sign on imagining in patients with normal liver enzymes should warrant further investigation with EUS to avoid missing serious pathological conditions such as stones, sludge, stricture, or a mass.

Curriculum for diagnostic endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in diagnostic endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in diagnostic EUS. This curriculum is set out in terms of the prerequisites prior to training; the recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1:  Trainees should have achieved competence in upper gastrointestinal endoscopy before training in diagnostic EUS. 2:  The development of diagnostic EUS skills by methods that do not involve patients is advisable, but not mandatory, prior to commencing formal training in diagnostic EUS. 3:  A trainee's principal trainer should be performing adequate volumes of diagnostic EUSs to demonstrate maintenance of their own competence. 4:  Training centers for diagnostic EUS should offer expertise, as well as a high volume of procedures per year, to ensure an optimal level of quality for training. Under these conditions, training centers should be able to provide trainees with a sufficient wealth of experience in diagnostic EUS for at least 12 months. 5:  Trainees should engage in formal training and supplement this with a range of learning resources for diagnostic EUS, including EUS-guided fine-needle aspiration and biopsy (FNA/FNB). 6:  EUS training should follow a structured syllabus to guide the learning program. 7:  A minimum procedure volume should be offered to trainees during diagnostic EUS training to ensure that they have the opportunity to achieve competence in the technique. To evaluate competence in diagnostic EUS, trainees should have completed a minimum of 250 supervised EUS procedures: 80 for luminal tumors, 20 for subepithelial lesions, and 150 for pancreaticobiliary lesions. At least 75 EUS-FNA/FNBs should be performed, including mostly pancreaticobiliary lesions. 8:  Competence assessment in diagnostic EUS should take into consideration not only technical skills, but also cognitive and integrative skills. A reliable valid assessment tool should be used regularly during diagnostic EUS training to track the acquisition of competence and to support trainee feedback. 9:  A period of supervised practice should follow the start of independent activity. Supervision can be delivered either on site if other colleagues are already practicing EUS or by maintaining contacts with the training center and/or other EUS experts. 10:  Key performance measures including the annual number of procedures, frequency of obtaining a diagnostic sample during EUS-FNA/FNB, and adverse events should be recorded within an electronic documentation system and evaluated.

Therapeutic Endoscopic Ultrasound for Complications of Pancreatic Cancer.

Progression of pancreatic adenocarcinoma can result in disease complications such as biliary obstruction and gastric outlet obstruction. The recent advances in endoscopic ultrasound (EUS) have transformed EUS from a purely diagnostic technology to a therapeutic modality, particularly with the development of lumen-apposing metal stents. In terms of biliary drainage, EUS-guided choledochoduodenostomy and EUS-guided hepaticogastrostomy offer safe and effective techniques when conventional transpapillary stent placement via ERCP fails or is not possible. If these modalities are not feasible, EUS-guided gallbladder drainage offers yet another salvage technique when the cystic duct is non-involved by the cancer. Lastly, EUS-guided gastroenterostomy allows for an effective bypass treatment for cases of gastric outlet obstruction that enables patients to resume eating within several days. Future randomized studies comparing these techniques to current standard-of-care options are warranted to firmly establish therapeutic EUS procedures within the treatment algorithm for this challenging disease.

Impact of EUS in liver transplantation workup for patients with unresectable perihilar cholangiocarcinoma

Background and study aimsFor a highly selected group of patients with unresectable perihilar cholangiocarcinoma (pCCA) liver transplantation (LT) is a treatment option. The Dutch screening protocol comprises non-regional lymph node (LN) assessment by endoscopic ultrasound (EUS) and whenever LN metastases are identified, further LT screening is precluded. The aim of this study is to investigate the yield of EUS in patients with pCCA who are potentially eligible for LT. MethodsIn this retrospective, nationwide cohort study, all consecutive patients with suspected unresectable pCCA who underwent EUS in the screening protocol for LT were included from 2011-2021. During EUS, sampling of a ‘suspicious’ non-regional LN was performed based on the endoscopists discretion. The primary outcome was the added value of EUS, defined as number of patients who were precluded from further screening due to malignant LN. ResultsA total of 75 patients was included in whom 84 EUS procedures were performed, with EUS guided tissue acquisition confirming malignancy in LN in 3/75 (4%) patients. In the 43 who underwent surgical staging conform the protocol, non-regional LN were identified in 6 (14%) patients. Regional LN were found in 7 patients in post-LT resected specimens. ConclusionsOur current EUS screening for the detection of malignant LN in patients with pCCA eligible for LT shows a limited but clinically important yield. EUS with systematic screening of all LN stations, both regional and non-regional and sampling of ‘suspicious’ lymph nodes according to defined and set criteria could potentially increase this yield.

Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial

Endoscopic ultrasonography (EUS) is a key procedure for the diagnosis of biliopancreatic diseases. However, the performance among EUS endoscopists varies greatly and leads to blind spots during the operation, which can impair the health outcomes of patients. We previously developed an artificial intelligence (AI) device that accurately identified EUS standard stations and significantly reduced the difficulty of ultrasonography image interpretation. In this study, we updated the device (named EUS-IREAD) and validated its performance in improving the quality of EUS procedures. In this single-centre, randomised, controlled trial, we updated EUS-IREAD so it consisted of five learning models to identify eight EUS stations and 24 anatomical structures. The trial was done at the Renmin Hospital of Wuhan University (Wuhan, China) and included patients aged 18 years or older with suspected biliopancreatic (pancreas and biliopancreatic duct) lesions due to clinical symptoms, radiological findings, or laboratory findings, and with a high risk of pancreatic cancer. Patients were randomly assigned (1:1) by a dedicated research assistant using a computer-generated random number series (with a block size of four) to undergo the EUS procedure with or without the assistance of EUS-IREAD. Endoscopists in the EUS-IREAD-assisted group were required to observe all standard stations and anatomical structures according to the prompts by the AI device. Data collectors, the independent data anaylsis team, and patients were masked to group allocation. The primary outcome was the missed scanning rate of standard stations between the two groups, which was assessed in patients who underwent EUS procedure in accordance with the assigned intervention (per protocol). This trial is registered with ClinicalTrials.gov, NCT05457101. Between July 9, 2022, and Feb 28, 2023, 290 patients (mean age 55·93 years [SD 14·06], 152 [52%] male, and 138 [48%] female) were randomly assigned and analysed, including 144 in the EUS-IREAD-assisted group and 146 in the control group. The EUS-IREAD-assisted group had a lower missed scanning rate of stations than the control group (4·5% [SD 0·8] vs 14·3% [1·0], -9·8% [95% CI -12·2 to -7·5]; odds ratio 3·6 [95% Cl 2·6 to 4·9]; p<0·0001). No significant adverse event was found during the study. Our study confirms the capability of EUS-IREAD to monitor the blind spots and reduce the missed rate of stations and structures during EUS procedures. The EUS-IREAD has the potential to play an essential part in EUS quality control. Innovation Team Project of Health Commission of Hubei Province and College-enterprise Deepening Reform Project of Wuhan University.

THE IMPACT OF THE COVID-19 PANDEMIC ON ENDOSCOPIC ULTRASOUND PROCEDURES IN A HIGH-VOLUME ENDOSCOPY UNIT IN BRAZIL.

•In pancreatic neoplasms the EUS plays a key role in the management. •During the pandemic period, lockdown measures prevented patients with comorbidities from performing EUS. •The D-EUS decreased during COVID-19, while I-EUS increased and EUS-TA was the most commonly I-EUS procedure performed, with no increase in adverse events. •Despite the moderate impact of the pandemic period in endoscopic services around the world, EUS-TA of solid and cystic tumors of the pancreas was the main indication. Background - Reports of the impact of the 2020 COVID-19 pandemic period/2020 on endoscopic ultrasound (EUS) are scarce. Objective - We analyzed the impact of the pandemic period/2020 on the demographics, indications, and number of diagnostic EUS (D-EUS) and interventional EUS (I-EUS) procedures performed in a high-volume endoscopy unit compared with the previous non-pandemic period/2019. Methods - We retrospectively reviewed the medical records of all patients undergoing D-EUS or I-EUS from March 1, 2019, to February 29, 2020 (non-pandemic period/2019) and from March 1, 2020, to February 28, 2021 (pandemic period/2020). Data compared between the study periods included sex, age, comorbidities, EUS findings and diagnosis, need for interventional procedures during EUS, and adverse events (AEs). Results were significant at P<0.05. Results - EUS procedures decreased from 475 in the non-pandemic period/2019 to 289 in the pandemic period/2020, accounting for a 39% reduction. In non-pandemic period/2019, 388 (81.7%) D-EUS and 88 (18.5%) I-EUS were performed, against 206 (71.3%) D-EUS and 83 (28.7%) I-EUS in pandemic period/2020 (P=0.001). Only 5/289 (1.7%) patients had COVID-19. Fewer patients with comorbidities underwent EUS during pandemic period/2020 due to lockdown measures (P<0.001). D-EUS decreased, whereas I-EUS increased (P<0.001). EUS-guided tissue acquisition (EUS-TA) was the most common I-EUS, performed in 83/289 (28.7%) patients in pandemic period/2020, against 88/475 (18.5%) in non-pandemic period/2019 (P=0.001). AEs did not differ significantly between the study periods. Conclusion - Pandemic Period/2020 had a moderate impact on reducing EUS procedures due to the risks involved. Although I-EUS increased, EUS-related AEs did not. Solid and cystic pancreatic tumors remained a major indication for EUS-TA even during the pandemic period/2020.

Needle-based confocal laser endomicroscopy for real-time granuloma detection.

Needle-based confocal laser endomicroscopy (nCLE) allows real-time microscopic imaging at the needle tip. nCLE malignancy criteria are used for tool-in-lesion confirmation during bronchoscopic lung nodule analysis. However, to date, nCLE criteria for granulomas are lacking. The aim was to identify and validate nCLE granuloma criteria and assess if blinded raters can distinguish malignant from granulomatous nCLE videos. In patients with suspected sarcoidosis, nCLE-imaging of mediastinal lymph nodes was performed during endoscopic ultrasound procedures, followed by needle aspiration. nCLE granuloma criteria were identified by comparison with pathology and final diagnoses. Additionally, nCLE-videos of granulomatous lung nodules part of prospective trials and clinical care were compared to the proposed nCLE granuloma criteria. Blinded raters validated nCLE videos of sarcoid and reactive mediastinal lymph nodes and malignant and granulomatous lung nodules twice. Granuloma criteria were identified (brighter-toned, homogeneous and well-demarcated lesions) based on nCLE-imaging in 14 sarcoidosis patients. Raters evaluated 26 nCLE-videos obtained in lymph nodes (n = 15 sarcoidosis; n = 11 reactive and total of 260 ratings). Granuloma criteria were recognized with 88% accuracy. The inter-observer (κ = 0.63, 95% CI 0.54-0.72) and intra-observer reliability (κ = 0.70 ± 0.06) were substantial. Based on 12 nCLE-videos obtained in lung nodules (n = 4 granulomas, n = 6 malignancy, n = 2 malignancy + granulomas and total of 120 ratings) granuloma and malignancy criteria were recognized with 92% and 75% accuracy. nCLE imaging facilitates real-time granuloma visualization. Blinded raters accurately and consistently recognized granulomas on nCLE-imaging and distinguished nCLE granuloma criteria from malignancy. Our data show the potential of nCLE as a real-time bronchoscopic guidance tool for lung nodule analysis.

Diagnostic Performance of Endoscopic Ultrasonography with Water-Filled Balloon Method for Superficial Esophageal Squamous Cell Carcinoma.

Endoscopic ultrasonography (EUS) is a commonly used tool for preoperative depth diagnosis of superficial esophageal squamous cell carcinoma (ESCC). Probing EUS using the water-filled balloon method is a simple and safe examination. The aim of this study was to clarify the diagnostic performance of EUS with the water-filled balloon method for superficial ESCC compared to magnifying narrow-band imaging (ME-NBI). We retrospectively examined 403 lesions in 393 consecutive patients diagnosed with ESCC and evaluated them with ME-NBI and EUS. Clinicopathological findings were collected, and the accuracy of the preoperative diagnosis was compared between ME-NBI and EUS-B. EUS examiners were not blinded to prior ME-NBI results, and EUS results may have been influenced by ME-NBI results. The pathological tumor depth of the EP/LPM in 152 lesions, MM/SM1 in 130 lesions, and deep submucosa (SM2/SM3) in 121 lesions was examined. The proportion of total lesions with an accurate diagnosis was significantly higher in EUS than in ME-NBI (67.7% versus 62.0%, P = 0.015). When analyzed by clinical depth diagnosis using ME-NBI, the proportion of lesions with an accurate diagnosis was significantly higher for EUS in MM/SM1 (55.7% versus 46.1%, P = 0.033). The sensitivity was significantly higher in EUS for SM2/SM3 lesions (76.0% versus 54.5%, P < 0.001). The accuracy and specificity of EUS, which differentiate MM/SM1 from EP/LPM or SM2/SM3, were significantly higher than those of ME-NBI. The median endoscopic ultrasonography procedure time was approximately 6.5min. EUS with the water-filled balloon method is a safe and straightforward method that can be performed on lesions clinically diagnosed as MM/SM1 using ME-NBI. We retrospectively reviewed lesions in patients diagnosed with ESCC and evaluated them using magnifying endoscopy with narrow-band imaging (ME-NBI) and endoscopic ultrasound using the water-filled balloon method (EUS-B). We conclude that EUS-B can increase the diagnostic accuracy.

Üçüncü Basamak Hastanede Endoskopik Ultrasonografi: Tek Merkez Deneyimi

Introduction : Endoscopic ultrasonography (EUS) is widely used to determine the character of lesions in the hepatobiliary system, pancreas, mediastinum, and rectum, in addition to subepithelial lesions of the upper gastrointestinal tract and for staging in addition to sampling from the lesion.Aim: The aim of this study is to present the endoscopic ultrasonography experience of our clinic over the last year. Material and Methods: EUS indication were performed by two gastroenterologists using a Pentax EPK-i5000 video processor and linear and radial echoendoscopes, under the guidance of an anesthesiologist under sedoanalgesia. Data were analyzed using descriptive statistics. The study results were analyzed using SPSS vn. 22.0 software.Results: Evaluation was made of 155 patients who underwent endoscopic ultrasonography, comprising 88 (56.8%) females and 67 (43.2%) males with a mean age of 56.3±14.2 years (range: 19-91 years). The 41 patients who underwent the EUS procedure for pancreatic lesion comprised 24 (59%) males and 17 (41%) females with a mean age of 54.3±17.1 years.EUS was performed in 74 patients due to subepithelial lesions of the upper gastrointestinal tract. These patients comprised 39 (52.7%) females and 35 (47.3%) males with a mean age of 55.2±13.5 years. Discussion The results of this study show that EUS is a reliable and very useful tool in appropriate indications, especially for the evaluation of subepithelial and malignant lesions of the gastrointestinal tract, pancreas, and ampulla pathologies. Conclusion and suggestions: Endoscopic ultrasonography; It is an effective and guiding method used in the diagnosis of submucosal lesions of the gastrointestinal tract, staging of malignant lesions, and the diagnosis of cystic and solid lesions of the pancreas.

Quality indicators of endoscopic ultrasound in the pancreatobiliary system: a brief review of current guidelines.

Since its development, the use of endoscopic ultrasonography (EUS) in the pancreas and the biliary tract has become increasingly important. The accuracy of EUS varies depending on the experience of the endoscopist. Hence, quality control measures using appropriate indicators are required to reduce these variations. American Society for Gastrointestinal Endoscopy and European Society of Gastrointestinal Endoscopy have announced the EUS quality indicators. Here, we reviewed the quality indicators of the EUS procedure in the current published guidelines.

Comparative study of analgesia quality with dextromethorphan gargling and lidocaine spray during the endoscopic ultrasound procedure: A randomized trial

Aim and backgroundEndoscopic ultrasound (EUS) is a method used to examine body structures. This method has various complications. Different methods have been invented to reduce these side effects. The present study was conducted to investigate the effect of dextromethorphan(DXM) gargling on analgesia and improving recovery after EUS. Materials and methodsAfter obtaining informed consent, patients are divided into two groups. One group was given DXM gargling before EUS and the other group was sprayed with lidocaine in their throat. EUS is performed for patients and analgesia and quality of recovery were checked during recovery. ResultShowed less sore throat, cough, and more ability to swallow saliva and patients' satisfaction of operation in the DXM group. However, the free-pain period(FPP) was higher in people receiving lidocaine. ConclusionCompared with lidocaine, DXM gargling improves the quality of recovery and pain relief after EUS and could be used instead of lidocaine. https://fa.irct.ir/trial/64301, IRCT20200612047740N5.

Risk factors of anastomosis-related difficult endoscopic retrograde cholangiopancreatography following endoscopic ultrasound-guided gastro-gastrostomy using astandardized protocol (with video).

Little is known about how to perform the endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) in patients with gastric bypass using lumen-apposing metal stents (LAMS). The aim was to assess the risk factors of anastomosis-related difficult ERCP. Observational single-center study. All patients who underwent an EDGE procedure in 2020-2022 following a standardized protocol were included. Risk factors for difficult ERCP, defined as the need of >5 min LAMS dilation or failure to pass a duodenoscope in the second duodenum, were assessed. Forty-five ERCPs were performed in 31 patients (57.4± 8.2 years old, 38.7% male). The EUS procedure was done using a wire-guided technique (n= 28, 90.3%) for biliary stones (n= 22, 71%) in most cases. The location of the anastomosis was gastro-gastric (n= 24, 77.4%) and mainly in the middle-excluded stomach (n= 21, 67.7%) with an oblique axis (n= 22, 71%). The ERCP technical success was 96.8%. There were 10 difficult ERCPs (32.3%) due to timing (n= 8), anastomotic dilation (n= 8), or failure to pass (n= 3). By multivariable analysis adjusted by two-stage procedures, the risk factors for a difficult ERCP were the jejuno-gastric route (85.7% vs. 16.7%; odds ratio [ORa ] 31.875; 95% confidence interval [CI] 1.649-616.155; P= 0.022), and the anastomosis to the proximal/distal excluded stomach (70% vs. 14.3%; ORa 22.667; 95% CI 1.676-306.570; P= 0.019). There was only one complication (3.2%) and one persistent gastro-gastric fistula (3.2%) in a median follow-up of 4 months (2-18 months), with no weight regain (P= 0.465). The jejunogastric route and the anastomosis with the proximal/distal excluded stomach during the EDGE procedure increase the difficulty of ERCP.

Role of interventional endoscopic ultrasound in a developing country.

Endoscopic ultrasound (EUS) has become an essential diagnostic and therapeutic tool. EUS was introduced in 2013 in Indonesia and is considered relatively new. This study aimed to describe the current role of interventional EUS at our hospital as a part of the Indonesian tertiary health center experience. This retrospective study included all patients who underwent interventional EUS (n=94) at our center between January 2015 and December 2020. Patient characteristics, technical success, clinical success, and adverse events associated with each type of interventional EUS procedure were evaluated. Altogether, 94 interventional EUS procedures were performed at our center between 2015 and 2020 including 75 cases of EUS-guided biliary drainage (EUS-BD), 14 cases of EUS-guided pancreatic fluid drainage, and five cases of EUS-guided celiac plexus neurolysis. The technical and clinical success rates of EUS-BD were 98.6% and 52%, respectively. The technical success rate was 100% for both EUS-guided pancreatic fluid drainage and EUS-guided celiac plexus neurolysis. The adverse event rates were 10.6% and 7.1% for EUS-BD and EUS-guided pancreatic fluid drainage, respectively. EUS is an effective and safe tool for the treatment of gastrointestinal and biliary diseases. It has a low rate of adverse events, even in developing countries.

Distal Endoscopic Attachments

AbstractEndoscopy is an evolving science and the last two decades has seen it expand exponentially at a pace unapparelled in the past. With the advancement in new procedures like image-enhanced endoscopy, magnifying endoscopy, third space endoscopy, and highly advanced endoscopic ultrasound procedures, endoscopic accessories are also evolving to cater the unmet needs. Endoscopic cap or distal attachment cap is a simple but very important accessory in the endoscopists' armamentarium which has changed the path of endoscopic procedures. It has so far been used commonly mostly for variceal ligation and endoscopic mucosal resections for colorectal polyps. But the horizon of its use has expanded in the recent years for difficult clinical scenarios like providing stability to the endoscope, overcoming blind spots during screening colonoscopies, maintaining clear field of vision during endotherapy of gastrointestinal bleeding, and during magnification endoscopy for lesion characterizations and so on. These caps are of different shapes, sizes, colors, and material depending on manufacturers and their implications while performing varied endoscopies. This review summarizes the clinical utilities of the cap in diagnostic as well as therapeutic endoscopy and its expanding indications of use.

Trial in Progress: 2019-1001 A Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma (LAPC or BRPC)

<h3>Purpose/Objective(s)</h3> Patients with pancreatic ductal adenocarcinoma (PDAC), who are not eligible for surgery after induction chemotherapy often receive radiation. Although radiation therapy (RT) improves local disease control, the placement of the pancreas proves to be difficult when safely delivering therapeutic doses. NBTXR3 is a novel, potentially first-in-class radio enhancer, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by RT. Pre-clinical testing suggests up to a 9-fold enhancement of the RT dose delivered within tumor cells. In this phase 1 trial-in-progress, the primary objective is to determine the recommended phase II dose (RP2D) of NBTXR3 for LAPC and BRPC patients undergoing RT. The secondary objectives are to evaluate the safety, feasibility, and anti-tumor response of NBTXR3 intratumoral injection on PDAC patients as well as time-to-event outcomes of subjects. <h3>Materials/Methods</h3> For the dose-finding part 1 of the study, patients with LAPC and no metastatic disease after at least 2-6 months of chemotherapy will be eligible. For part 2, the expansion at RP2D, patients with BRPC or LAPC and no metastatic disease after chemotherapy will be eligible. The statistical design of the trial uses a Bayesian optimal interval (BOIN) design. A maximum of 24 patients will be enrolled. For baseline and follow-up, imaging and blood biomarkers will be collected. Patients enrolled will receive NBTXR3, once, through intratumoral injection via endoscopic ultrasound (Day 1). Pre-treatment biopsy will be collected. Post NBTXR3 injection, blood samples will be collected at 4 time points (0,5,30, and 120 minutes). Two urine voids will be collected post injection for hafnium quantification as well. At least three days later, patients will undergo imaging for RT dosimetry and planning where NBTXR3 can be visualized. Patients will then receive 45 Gy in 15 fractions with IMRT, with regional nodal basins receiving 37.5 Gy. Follow-up period will begin 4 weeks after end of treatment and continue every 3 months for a year. Patients will be evaluated for surgery 4-12 weeks post RT. At 11-13 weeks after end of RT, if the patient is not eligible for surgery, an endoscopic ultrasound procedure will be performed. In both events, a post-treatment biopsy will be obtained. The imaging collected of pancreatic target lesion will be used to determine tumor response as per RECIST v1.1 criteria. <h3>Results</h3> Trial is open and accruing, with 8 patients enrolled so far. <h3>Conclusion</h3> We expect to determine the RP2D, safety, and preliminary efficacy of NBTXR3 in pancreatic cancer with this study with blood, tissue, and imaging correlates in 2022.