EUS development in China: Results from national surveys in 2013 and 2020.

Background and Objectives: EUS has recently gained attraction in mainland China. This study aimed to evaluate the development of EUS from results of two national surveys. Methods: EUS-related information, including infrastructure, personnel, volume, and quality indicator, was extracted from the Chinese Digestive Endoscopy Census. Data from 2012 and 2019 were compared, and differences among various hospitals and regions were analyzed. The EUS rates (EUS annual volume per 100,000 inhabitants) between China and developed countries were also compared. Results: The number of hospitals performing EUS in mainland China increased from 531 to 1236 (2.33-fold), and 4025 endoscopists performed EUS in 2019. The volumes of all EUS and interventional EUS increased from 207,166 to 464,182 (2.24-fold) and 10,737 to 15,334 (1.43-fold), respectively. The EUS rate in China was lower than that in developed countries but showed a higher growth rate. EUS rate varied substantially among different provincial regions (in 2019: 4.9-152.0 per 100,000 inhabitants) and showed significant positive association with gross domestic product per capita (in 2019: r = 0.559, P = 0.001). The EUS-FNA-positive rate in 2019 was comparable between hospitals in terms of annual volume (≥50 or < 50: 79.9% vs. 71.6%, P = 0.704) and practice duration (starting EUS-FNA before or after 2012: 78.7% vs. 72.6%, P = 0.565). Conclusion: EUS has developed considerably in China in recent years but still needs substantial improvement. More resources are in demand for hospitals in less-developed regions and with low EUS volume.

Comparative Performance of Endoscopic Ultrasound-Based Techniques in Patients With Pancreatic Cystic Lesions: A Network Meta-Analysis.

INTRODUCTION: Evidence on the comparative diagnostic performance of endoscopic ultrasound (EUS)-based techniques for pancreatic cystic lesions (PCLs) is limited. This network meta-analysis comprehensively compared EUS-based techniques for PCL diagnosis. METHODS: A comprehensive literature search was performed for all comparative studies assessing the accuracy of 2 or more modalities for PCL diagnosis. The primary outcome was the diagnostic efficacy for mucinous PCLs. Secondary outcomes were the diagnostic efficacy for malignant PCLs, diagnostic success rate, and adverse event rate. A network meta-analysis was conducted using the ANOVA model to assess the diagnostic accuracy of each index. RESULTS: Forty studies comprising 3,641 patients were identified. The network ranking of the superiority index for EUS-guided needle-based confocal laser endomicroscopy (EUS-nCLE) and EUS-guided through-the-needle biopsy (EUS-TTNB) were significantly higher than other techniques for differentiating mucinous PCLs; besides, EUS-TTNB was also the optimal technique in identifying malignant PCLs. The evidence was inadequate for EUS-nCLE diagnosing malignant PCLs and contrast-enhanced harmonic EUS diagnosing both mucinous and malignant PCLs. Glucose showed a high sensitivity but low specificity, and molecular analysis (KRAS, GNAS, and KRAS + GNAS mutations) showed a high specificity but low sensitivity for diagnosing mucinous PCLs. Satisfactory results were not obtained during the evaluation of the efficiency of pancreatic cyst fluid (PCF) biomarkers in detecting malignant PCLs. DISCUSSION: For centers with relevant expertise and facilities, EUS-TTNB and EUS-nCLE were better choices for the diagnosis of PCLs. Further studies are urgently required for further improving PCF biomarkers and validating the diagnostic performance of the index techniques.

Optimal sampling technique for EUS-guided fine-needle biopsy of solid pancreatic lesions using a 25-gauge ProCore needle: A multicenter randomized crossover superiority study.

Background and Objectives: It remains unclear whether the use of the stylet slow-pull (SP) and wet suction (WS) can improve the yield of endoscopic ultrasound-guided fine-needle biopsy compared to standard suction (SS). The aim of this study was to compare the diagnostic efficacy of the three sampling techniques when using 25G ProCore needles for solid pancreatic lesions. Materials and Methods: This multicenter single-blind randomized crossover superiority trial enrolled patients with solid pancreatic lesions (n = 300) from four digestive endoscopic centers in China. All three sampling techniques were performed on each patient using a 25G ProCore needle in a randomized sequence. The diagnostic efficacy, the specimen yield, and quality of each technique, the overall technical success rate and diagnostic yield of the 25G ProCore needle, and rate of adverse events were evaluated. Results: A total of 291 patients were analyzed. No significant difference was found in diagnostic efficiency among the three techniques (sensitivity, 82.14% vs. 75.00% vs. 77.86, P = 0.1186; accuracy, 82.82% vs. 75.95% vs. 78.69%, P = 0.1212). The SP had an inferior tissue integrity compared to the SS and WS techniques (71.82% vs. 62.55% vs. 69.76%, P = 0.0096). There was no significant difference in the degree of blood contamination among the three groups (P = 0.2079). After three passes, the overall sensitivity was 93.93%, and the accuracy was 94.16%. Conclusions: SS and WS techniques are better choices than SP technique for 25G ProCore needle, for they could provide higher specimen adequacy without increasing the amount of blood contamination. The 25G ProCore needle can provide a satisfactory diagnostic yield for solid pancreatic lesions.

Changhai advanced endoscopy courses for ERCP (CHANCE) training program: A short-term training model in China.

BACKGROUND: There is huge shortage of ERCP practitioners (ERCPists) in China, and ERCP training is urgently needed. ChangHai Advanced eNdoscopy Courses for ERCP (CHANCE) is a 4-month program for ERCP training since 2004. This study evaluated the efficiency of this short-term training model, and reported on the ERCP careers of the trainees following completion of the CHANCE program. METHODS: This study was a retrospective investigation included all the CHANCE trainees from Jan 2004 to Dec 2014. Questionnaires were sent to all trainees. The career competence percentage, ERCP careers and predictive factors of career competence were investigated and analyzed. RESULTS: A total of 413 trainees participated in the CHANCE program over 11 years covered by the survey and 258 questionnaires were valid for the study. The mean (SD) age of the trainees was 35.36 (4.17), and the male to female ratio was 4.4:1. The average follow-up time was 7.77 (3.44) years. A total of 173 (67.1%) trainees had achieved career competence. In terms of ERCP careers, the mean annual ERCP volume was 120.60 (96.67), with a complication percentage of 8.2%. Hospital qualification, compliance with follow-up learning guidance, participating academic activity, and practitioner type were identified predictive factors of career competence. CONCLUSIONS: As a short-term training program, the CHANCE achieved an acceptable career competence percentage, providing endoscopists more chances to learn ERCP and giving them appropriate training guidance for career competence. This training mode is worth promoting in developing countries with shortage of ERCPists.

Independent risk factors for true malignancy in atypical cytologic diagnostic category in EUS-FNA/FNB of the pancreas: A novel prediction model.

Background and Objects: An atypical cytologic diagnosis arises from inflammation or early neoplastic process. It is commonly found in EUS-guided fine-needle aspiration/biopsy (EUS-FNA/FNB) tissue sampling of pancreatic malignancies. The aims of this study were to evaluate the diagnostic performance of EUS-FNA/FNB in patients with cytologic diagnosis of atypical cells and to develop a prediction model for malignant tumors of the pancreas in the atypical cytologic diagnostic category. Methods: Two hundred and twenty-six patients in the atypical cytologic diagnostic category were analyzed. Multivariate logistic regression analyses were performed to determine predictive factors for pancreatic malignancies. The final diagnoses were confirmed by repeat biopsy; surgical pathology, or clinical follow-up for at least 6 months. Results: The atypical cytologic diagnosis using EUS-FNA/FNB was associated with an absolute risk of malignancy (82.3%). Multivariate logistic regression analyses revealed that older age, long axis of the mass, and increased carbohydrate antigen 19-9 (CA19-9) were independent risk factors for true malignant pancreatic tumors among patients in the atypical cytologic diagnostic category. The calibration curve had a slope of 0.96, and a regression coefficient (R2) of 0.91. The area under the receiver operating characteristic curve of the validation group was 0.803. Conclusions: Atypical lesions of EUS-FNA/FNB have a higher risk of malignancy. Older age, the long axis of the mass, and elevated serum CA19-9 level were identified as independent risk factors for true malignant pancreatic tumors among patients in the atypical cytologic diagnostic category.

Impact of parenchyma-preserving surgical methods on treating patients with solid pseudopapillary neoplasms: A retrospective study with a large sample size.

BACKGROUND: Solid pseudopapillary neoplasm (SPN) of the pancreas is a rare neoplasm that mainly affects young women. AIM: To evaluate the impact of parenchyma-preserving surgical methods (PPMs, including enucleation and central pancreatectomy) in the treatment of SPN patients. METHODS: From 2013 to 2019, patients who underwent pancreatectomy for SPNs were retrospectively reviewed. The baseline characteristics, intraoperative index, pathological outcomes, short-term complications and long-term follow-up data were compared between the PPM group and the conventional method (CM) group. RESULTS: In total, 166 patients were included in this study. Of them, 33 patients (19.9%) underwent PPM. Most of the tumors (104/166, 62.7%) were found accidentally. Comparing the parameters between groups, the hospital stay d (12.35 vs 13.5 d, P = 0.49), total expense (44213 vs 54084 yuan, P = 0.21), operation duration (135 vs 120 min, P = 0.71), and intraoperative bleeding volume (200 vs 100 mL, P = 0.49) did not differ between groups. Regarding pathological outcomes, tumor size (45 vs 32 mm, P = 0.07), Ki67 index (P = 0.53), peripheral tissue invasion (11.3% vs 9.1%, P = 0.43) and positive margin status (7.5% vs 6%, P = 0.28) also did not differ between groups. Moreover, PPM did not increase the risk of severe postoperative pancreatic fistula (3.8% vs 3.0%, P = 0.85) or tumor recurrence (3.0% vs 6.0%, P = 0.39). However, the number of patients who had exocrine insufficiency during follow-up was significantly lower in the PPM group (21.8% vs 3%, P = 0.024). CM was identified as an independent risk factor for pancreatic exocrine insufficiency (odds ratio = 8.195, 95% confident interval: 1.067-62.93). CONCLUSION: PPM for SPN appears to be feasible and safe for preserving the exocrine function of the pancreas.

Association between sedation and small neoplasm detection during diagnostic esophagogastroduodenoscopy: a propensity score-matched retrospective study.

BACKGROUND: Esophagogastroduodenoscopy (EGD) is fundamental for detecting upper gastrointestinal (GI) neoplasms. However, the impact of sedation on small neoplasm detection during EGD has not been evaluated. The aim of this study was to investigate whether EGD with sedation could improve small upper GI neoplasm detection. METHODS: This propensity score-matched retrospective study analyzed the medical records of outpatients undergoing diagnostic EGD at a large tertiary center between January 2013 and December 2018. The primary outcome was the detection rate of small upper GI neoplasms (≤10 mm). The secondary outcomes were biopsy rate and small neoplasms in different anatomic subsites. RESULTS: After propensity score matching, 20,052 patients undergoing diagnostic EGD with or without propofol sedation were identified. A higher detection rate of small upper GI neoplasms was observed in the sedation group (2.80% vs. 2.02%; p < .001). In particular, the detection rate of small cancers in the sedation group was 3-fold higher than that in the no-sedation group (0.16% vs. 0.05%; p = .023). Small neoplasms were more likely identified at the gastric antrum (1.60% vs. 1.09%; p = .002) and angulus (0.66% vs. 0.45%; p = .044) in the sedation group. In addition, endoscopists were more likely to take biopsies when performing sedated EGD (41.4% vs. 36.4%, p < .001), and a higher biopsy rate was associated with an increased detection rate of small neoplasms. CONCLUSIONS: Sedation was significantly associated with a higher detection rate of small upper GI neoplasms and might be recommended for improving the quality of EGD.

Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial.

BACKGROUND: Pancreatitis is the most common complication of pancreatic extracorporeal shock wave lithotripsy (ESWL). There has been little research into effective prevention of post-ESWL pancreatitis. Therefore, we aimed to assess the efficacy of prophylactic rectal indometacin in preventing post-ESWL pancreatitis. METHODS: In this double-blind, randomised, placebo-controlled trial done at Changhai Hospital (Shanghai, China), patients aged 18 years or older with chronic pancreatitis and pancreatic stones (>5 mm in diameter) who were eligible for treatment with ESWL were randomly allocated using a computer-generated randomisation table, in a 1:1 ratio, to receive 100 mg rectal indometacin or identical glycerin (placebo) suppositories 30 min before ESWL. Patients, endoscopists, and outcome assessors were masked to group allocation. The primary outcome was the incidence of post-ESWL pancreatitis within 24 h of ESWL, analysed by the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT02797067. FINDINGS: Between May 31, 2016, and June 26, 2019, 1370 patients were enrolled, with 685 patients randomly assigned to the rectal indometacin group and 685 patients to the placebo group. All patients received their allocated intervention and completed final follow-up, and were included in the intention-to-treat analysis. Post-ESWL pancreatitis occurred in 60 (9%) patients in the rectal indometacin group and 84 (12%) patients in the placebo group (relative risk 0·71, 95% CI 0·52-0·98; p=0·042). Transient adverse events occurred in 235 (34%) patients in the rectal indometacin group and 252 (37%) patients in the placebo group, with asymptomatic hyperamylasaemia being the most common (189 [28%] patients vs 197 [29%] patients). No difference was noted between groups in the incidence of other complications and transient adverse events. INTERPRETATION: Pre-procedural administration of rectal indometacin is an efficacious and safe means of reducing the incidence of post-ESWL pancreatitis. FUNDING: Programs of Shanghai Municipal Government and the "Ten Thousand Plan"-National High Level Talents Special Support Plan.

Establishment and validation of a computer-assisted colonic polyp localization system based on deep learning.

BACKGROUND: Artificial intelligence in colonoscopy is an emerging field, and its application may help colonoscopists improve inspection quality and reduce the rate of missed polyps and adenomas. Several deep learning-based computer-assisted detection (CADe) techniques were established from small single-center datasets, and unrepresentative learning materials might confine their application and generalization in wide practice. Although CADes have been reported to identify polyps in colonoscopic images and videos in real time, their diagnostic performance deserves to be further validated in clinical practice. AIM: To train and test a CADe based on multicenter high-quality images of polyps and preliminarily validate it in clinical colonoscopies. METHODS: With high-quality screening and labeling from 55 qualified colonoscopists, a dataset consisting of over 71000 images from 20 centers was used to train and test a deep learning-based CADe. In addition, the real-time diagnostic performance of CADe was tested frame by frame in 47 unaltered full-ranged videos that contained 86 histologically confirmed polyps. Finally, we conducted a self-controlled observational study to validate the diagnostic performance of CADe in real-world colonoscopy with the main outcome measure of polyps per colonoscopy in Changhai Hospital. RESULTS: The CADe was able to identify polyps in the test dataset with 95.0% sensitivity and 99.1% specificity. For colonoscopy videos, all 86 polyps were detected with 92.2% sensitivity and 93.6% specificity in frame-by-frame analysis. In the prospective validation, the sensitivity of CAD in identifying polyps was 98.4% (185/188). Folds, reflections of light and fecal fluid were the main causes of false positives in both the test dataset and clinical colonoscopies. Colonoscopists can detect more polyps (0.90 vs 0.82, P < 0.001) and adenomas (0.32 vs 0.30, P = 0.045) with the aid of CADe, particularly polyps < 5 mm and flat polyps (0.65 vs 0.57, P < 0.001; 0.74 vs 0.67, P = 0.001, respectively). However, high efficacy is not realized in colonoscopies with inadequate bowel preparation and withdrawal time (P = 0.32; P = 0.16, respectively). CONCLUSION: CADe is feasible in the clinical setting and might help endoscopists detect more polyps and adenomas, and further confirmation is warranted.

Validation of serum tumor biomarkers in predicting advanced cystic mucinous neoplasm of the pancreas.

BACKGROUND: Early detection of advanced cystic mucinous neoplasms [(A-cMNs), defined as high-grade dysplasia or malignancy] of the pancreas is of great significance. As a simple and feasible detection method, serum tumor markers (STMs) may be used to predict advanced intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms (MCNs). However, there are few studies on the usefulness of STMs other than carbohydrate antigen (CA) 19-9 for early detection of A-cMNs. AIM: To study the ability of five STMs-CA19-9, carcinoembryonic antigen (CEA), CA125, CA724, and CA242 to predict A-cMNs and distinguish IPMNs and MCNs. METHODS: We mainly measured the levels of each STM in patients pathologically diagnosed with cMNs. The mean levels of STMs and the number of A-cMN subjects with a higher STM level than the cutoff were compared respectively to identify the ability of STMs to predict A-cMNs and distinguish MCNs from IPMNs. A receiver operating characteristic curve with the area under curve (AUC) was also created to identify the performance of the five STMs. RESULTS: A total of 187 patients with cMNs were identified and 72 of them showed A-cMNs. We found that CA19-9 exhibited the highest sensitivity (SE) (54.2%) and accuracy (76.5%) and a moderate ability (AUC = 0.766) to predict A-cMNs. In predicting high-grade dysplasia IPMNs, the SE of CA19-9 decreased to 38.5%. The ability of CEA, CA125, and CA724 to predict A-cMNs was low (AUC = 0.651, 0.583, and 0.618, respectively). The predictive ability of CA242 was not identified. The combination of STMs improved the SE to 62.5%. CA125 may be specific to the diagnosis of advanced MCNs. CONCLUSION: CA19-9 has a moderate ability, and CEA, CA125, and CA724 have a low ability to predict A-cMNs. The combination of STM testing could improve SE in predicting A-cMNs.

Optimal number of needle passes during EUS-guided fine-needle biopsy of solid pancreatic lesions with 22G ProCore needles and different suction techniques: A randomized controlled trial.

BACKGROUND AND OBJECTIVES: The sensitivity of EUS-guided fine-needle biopsy (EUS-FNB) varies considerably. The optimal number of passes through a solid pancreatic lesion with a 22G FNB needle during EUS-FNB is controversial. This prospective randomized controlled study aimed to determine the optimal number of needle passes during EUS-FNB of solid pancreatic lesions, with 22G FNB needles and different sampling techniques. METHODS: Pancreatic masses were sampled using 22G FNB needles with either the stylet slow-pull (SP) technique or the standard-suction (SS) technique. We determined the number of needle passes required to obtain a diagnostic accuracy of >90%. Differences between the two techniques in terms of technical success rate, cytological acquisition, core tissue acquisition, sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and complications were analyzed. RESULTS: A total of 120 patients were randomly assigned to either SP or SS group. Three patients who were lost to follow-up and one who did not complete 5 passes due to bent needle head were excluded from the study. Fifty-six cases in the SP group and 60 cases in the SS group were included in the analysis. For SP technique, the cumulative accuracy of passes 1, 2, 3, 4, and 5 was 44.83%, 76.79%, 87.50%, 92.86%, and 94.64%, respectively. For SS technique, the cumulative accuracy of passes 1, 2, 3, 4, and 5 was 71.67%, 85.0%, 90.0%, 93.33%, and 95.0%, respectively. For each group, there was no statistically significant difference in accuracy after 3 and 4 passes. After 4 passes, the pooled sensitivity (92.59% vs. 93.10%), accuracy (92.86% vs. 93.10%), and specificity (100% vs. 100%) were similar (P > 0.05) in the SP and SS groups, respectively. In addition, positive cytological diagnoses (83.9% vs. 85.0%) and positive histological diagnoses (71.4% vs. 78.3%) were comparable (P > 0.05) in the SP and SS groups, respectively. No statistically significant factor was found associated with diagnostic sensitivity for each group. CONCLUSION: When on-site cytological evaluation is unavailable, we recommend that at least 3 passes with 22G ProCore needles be performed during EUS-FNB using the SS technique, at least 4 passes when using SP technique. The SS technique showed potential advantages over SP technique in tissue acquisition and diagnostic capabilities.

Endosonographers performing on-site evaluation of solid pancreatic specimens for EUS-guided biopsy: A formal training method and learning curves.

OBJECTIVES: This study aimed to examine the effects of a training program combining formal cytological curriculum and practical assessments on endosonographers and to determine how many operations were needed for training through learning curves. METHODS: A formal cytological curriculum was implemented in November 2019 for four endosonographers. The competency of endosonographers before and after the curriculum was judged by quantitative scores. From December 2019 to October 2020, trainees independently examined the adequacy and atypia grade of pancreatic specimens acquired by EUS-guided-fine-needle biopsy based on specific atypical grading criteria. The accuracy of the adequacy and atypia assessment of each trainee was calculated, and learning curves were drawn to evaluate the improvement. RESULTS: The median posttraining score improved by 87% from 49 to 91.5 out of 100. Ninety patients were enrolled in the practical assessments. The accuracy for specimen adequacy and atypia assessment of each trainee was 91.7%, 92.8%, 91.0%, and 89.3% and 80.0%, 82.1%, 81.0%, and 78.9%. The learning curves of each trainee showed a steady and significant improvement, and ninety cases were sufficient for satisfactory adequacy assessment. CONCLUSIONS: Basic knowledge of on-site cytopathologic evaluation can be gained through standardized and systematic training. Practical assessments showed that, at the completion of ninety cases, trained endosonographers reached a satisfactory level of recognizing specimen adequacy, but continue practice was needed for atypia assessment.

Defining the endoscopic ultrasound features of chronic pancreatitis in Asians: a multicenter validation study.

BACKGROUND: Although endoscopic ultrasound (EUS) features and criteria have been described in chronic pancreatitis, challenges remain with interoperator variability and ease of adoption. The aim of this study was to define and validate the EUS features of chronic pancreatitis in a multicenter prospective study in Asia. METHOD: The study was divided into two parts: the first part was conducted to derive the EUS features of chronic pancreatitis with adequate interoperator agreement; the second was to prospectively evaluate these features in a multicenter cross-sectional study and determine the optimal combination of features for the diagnosis of chronic pancreatitis. Prospectively enrolled cases had standard internationally validated radiologic or histologic features of chronic pancreatitis, and controls were patients without chronic pancreatitis who underwent EUS examination. RESULTS: The top six EUS features that had good interobserver agreement (mean kappa 0.73, range 0.60 - 0.90) were selected to be further evaluated in part II of the study. These included: hyperechoic foci with shadowing, lobularity with honeycombing, cysts, dilated main pancreatic duct, dilated side branches, and calculi in the main pancreatic duct. A total of 284 subjects (132 cases, 152 controls) were enrolled from 12 centers in Asia. All six features had high accuracy ranging from 63.3 % to 89.1 %. Two or more of these six EUS features accurately defined chronic pancreatitis (sensitivity 94.7 %, specificity 98.0 %), with an area under the receiver operating curve of 0.986. CONCLUSION: This multicenter Asian study characterized and defined the EUS features of chronic pancreatitis. This provides a useful tool in clinical practice and further research in pancreatic cancer surveillance.

Assessment of different modalities for repeated tissue acquisition in diagnosing malignant biliary strictures: A two-center retrospective study.

OBJECTIVE: Various modalities are applied for pathological diagnosis of malignant biliary strictures (MBS), including brush cytology (BC), forceps biopsy (FB) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). We aimed to assess the value of these modalities in a repeated tissue acquisition process for biliary strictures with initially inconclusive pathological outcomes. METHODS: Patients who were suspected of having MBS and underwent a BC in two large teaching hospitals were retrospectively included. The sensitivity, specificity, positive and negative predictive values, and accuracy of the initial and repeated BC, FB and EUS-FNA were analyzed. Their performances were compared to determine which modality was superior in repeated tissue acquisition. RESULTS: In total, 476 patients were included. The sensitivity, specificity and accuracy in diagnosing MBS for the initial BC were 30.3%, 100% and 55.0%, respectively. Altogether 39, 27 and 44 patients underwent a repeat BC, FB and EUS-FNA, respectively. The sensitivity for repeated BC, FB and EUS-FNA was 41.2%, 61.1% and 44.4%, respectively, whereas their specificity all reached 100%. When comparing diagnostic accuracy, none of the modalities was superior (74.4% vs 74.1% vs 54.5%, P = 0.173). In the repeated process, one patient who underwent BC and two underwent FB developed mild pancreatitis. CONCLUSIONS: Repeated tissue acquisition achieves a conclusive diagnosis of MBS in nearly half patients who have an initially inconclusive cytological diagnosis. None of the tissue acquisition methods is significantly superior in the repeated process.

Comparison of full-field optical coherence tomography imaging for pancreatic tissue sample obtained by EUS-fine-needle biopsy and conventional histological examination: A study protocol for a prospective trial.

For a definitive diagnosis of fine-needle aspiration (FNA)/biopsy, one of the reliable techniques to determine the adequacy and accuracy rapid on-site evaluation (ROSE) of cytological samples is preferable. Because of the lack of trained pathologists, alternatives have to be explored. This study is primarily conducted to determine the diagnostic sensitivity and specificity of full-field optical coherence tomography (FF-OCT) and secondarily to evaluate the possibility of FF-OCT differentiating different types of pancreatic diseases. The diagnostic coherence of FF-OCT by a trained assistant (endoscopist) and trained pathologist is also compared. This is a single-center, prospective, observation trial. Eighty patients would be enrolled in the study. The tissue samples acquired by endoscopic ultrasound fine-needle biopsy (EUS-FNB) would be imaged by the FF-OCT system, interpreted by a trained endoscopist and a pathologist. The results of the image interpretation would be verified with histological findings. This study determines the diagnostic capability of FF-OCT as a ROSE technique while performing EUS-FNB, and whether endoscopists can implement the assessment.

Diagnostic efficacy of three suction techniques for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions: protocol for a multicenter randomized cross-over clinical trial.

BACKGROUND: How suction technique affects endoscopic ultrasound-guided tissue acquisition (EUS-TA) remains unclear. A standardized protocol is currently lacking, with most previous studies being restricted to EUS-guided fine-needle aspiration (EUS-FNA). The research related to EUS-guided fine-needle biopsy (EUS-FNB) is sparse. AIMS: The aim of this study is to evaluate the diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate of three common suction techniques (standard suction, slow-pull, and wet suction) used for EUS-FNB of solid pancreatic masses. METHODS: This is a multicenter single-blind randomized cross-over superiority trial. A total of 300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China. All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization. Cytological and histological specimens obtained with each of the three techniques will be assessed independently. Outcomes among the three suction techniques will be compared. DISCUSSION: To the best of our knowledge, this is the largest multicenter randomized cross-over trial designed to determine the optimal suction technique for the diagnosis of solid pancreatic masses. This study may contribute to standardizing the suction technique for EUS-FNB.

Predictive factors for extraction of common bile duct stones during endoscopic retrograde cholangiopancreatography in Billroth II anatomy patients.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) for extraction of common bile duct (CBD) stones in Billroth II anatomy patients is still a technical challenge and factors affecting stone extraction have not yet been clarified. This study aimed to analyze our experience and evaluate potential factors affecting CBD stone extraction. METHODS: A retrospective analysis of CBD stones patients with a history of Billroth II gastrectomy, who underwent therapeutic ERCP for stone extraction at our center from August 1999 to December 2017, was conducted. The outcomes of ERCP and potential factors affecting stone extraction were examined. RESULTS: A total of 227 patients were enrolled, and 176 patients (77.5%) achieved technical success. The success rate of duodenal ampullary access and selective biliary cannulation was 84.1% (191/227) and 92.1% (176/191), respectively. The mean CBD diameter was 15 mm (range 6-35 mm), and the largest stone size was 13 mm (range 4-36 mm). CBD stones were ultimately removed in 137 patients (77.8%), and 105 patients (59.7%) for the first session. Mechanical lithotripsy was used in 17 patients (9.7%). The overall ERCP-related complication rate was 6.3% (11/176), including bleeding in 3 patients (1.7%) and mild pancreatitis in 6 patients (3.4%). The multivariate analysis indicated that CBD stone number ≥ 2 (OR 2.171; 95% CI 1.095-4.306; p = 0.027), and the largest CBD stone size ≥ 12 mm (OR 3.646; 95% CI 1.833-7.251; p < 0.001) were patient-related risk factors for failed stone removal; while the use of endoscopic papillary (large) balloon dilation (EPBD/EPLBD) (OR 0.291; 95% CI 0.147-0.576; p < 0.001) was a procedure-related protective factor for successful stone extraction. CONCLUSIONS: ERCP is safe and effective for extraction of CBD stones in Billroth II anatomy patients. The number and the largest size of CBD stones, and the use of EPBD/EPLBD are predictive factors for CBD stone extraction.

Comparison of smear cytology and liquid-based cytology in EUS-guided FNA of pancreatic lesions: experience from a large tertiary center.

BACKGROUND AND AIMS: Studies comparing the diagnostic efficacy of liquid-based cytology (LBC) and smear cytology (SC) of pancreatic tissue sampling obtained via EUS-guided FNA (EUS-FNA) are still insufficient, mainly because results were controversial. We compared the diagnostic efficiency of LBC and SC of EUS-FNA of pancreatic lesions in one of the largest tertiary hospitals in China. METHODS: A retrospective database search (January 2015 to January 2019) was performed for patients who underwent EUS-FNA with both LBC and SC. Demographic, cytologic, and endosonographic data were collected from 819 patients; 514 cases met the inclusion criteria. Diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were compared. Rapid on-site evaluation was not available in all cases. RESULTS: Three hundred eighty-five cases (74.90%) had confirmed malignancy, and 40 cases (7.78%) confirmed benign neoplasm. Adequate tissue sampling rates showed no significant difference between the 2 groups. The sensitivity, accuracy, and negative predictive value (NPV) of LBC were higher than those of SC with statistical significance (71.4% vs 55.1%, 76.1% vs 61.6%, and 40.6% vs 27.7%, respectively). The sensitivity, accuracy, and NPV of combined SC and LBC were higher than those of LBC alone with statistical significance (83.9% vs 71.4%, 86.5% vs 76.1%, and 56.8% vs 40.6%, respectively). Multivariate analysis revealed that pancreatic neck/body/tail lesions (P = .003), solid lesions (P < .001), 22-gauge needle size (P < .001), and number of needle passage >3 (P = .041) were associated with higher diagnostic sensitivity in all participants using LBC, whereas number of needle passage >3 (P = .017) was associated with higher diagnostic sensitivity using SC. CONCLUSIONS: LBC was more accurate and sensitive than SC in EUS-FNA of pancreatic lesions with higher NPV when rapid on-site evaluation is unavailable. Pancreatic neck/body/tail lesions, solid lesions, 22-gauge needle, and more than 3 passes were associated with higher sensitivity when using LBC. Performing more than 3 passes is associated with higher sensitivity when using SC.

Endoscopic retrograde cholangiopancreatography in Billroth II gastrectomy patients: Outcomes and potential factors affecting technical failure.

BACKGROUND/AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) in Billroth II gastrectomy patients is technically demanding and factors affecting its technical difficulty have not yet been clarified. This study aimed to investigate the outcomes of ERCP in Billroth II gastrectomy patients and identify potential factors affecting its technical failure. PATIENTS AND METHODS: A large retrospective study of 308 consecutive patients (391 procedures) with Billroth II gastrectomy-who underwent ERCP from January 2002 to December 2016-was conducted. The outcomes of ERCP and potential factors affecting its technical failure were analyzed. RESULTS: The success rate of duodenal ampullary access, selective duct cannulation and the accomplishment of expected procedures was 81.3% (318/391), 86.5% (275/318) and 97.3% (256/263), respectively, and the technical success rate was 70.3% (275/391). The overall ERCP-related complication rate was 15.3% (60/391). The multivariate analysis indicated that first-time ERCP attempt [odds ratio (OR) 4.29, 95% confidence interval (CI) 2.34-7.85, P < 0.001], Braun anastomosis (OR 3.65, 95% CI 1.38-9.64, P < 0.009), and no cap-assisted gastroscope (OR 3.05, 95% CI 1.69-5.51, P < 0.001) were significantly associated with technical failure. CONCLUSIONS: ERCP is safe, effective and feasible for Billroth II gastrectomy patients. Previous ERCP history, absence of Braun anastomosis and the use of a cap-assisted gastroscope are the predictive factors for its technical success.

Consensus on the digestive endoscopic tunnel technique.

With the digestive endoscopic tunnel technique (DETT), many diseases that previously would have been treated by surgery are now endoscopically curable by establishing a submucosal tunnel between the mucosa and muscularis propria (MP). Through the tunnel, endoscopic diagnosis or treatment is performed for lesions in the mucosa, in the MP, and even outside the gastrointestinal (GI) tract. At present, the tunnel technique application range covers the following: (1) Treatment of lesions originating from the mucosal layer, e.g., endoscopic submucosal tunnel dissection for oesophageal large or circular early-stage cancer or precancerosis; (2) treatment of lesions from the MP layer, per-oral endoscopic myotomy, submucosal tunnelling endoscopic resection, etc.; and (3) diagnosis and treatment of lesions outside the GI tract, such as resection of lymph nodes and benign tumour excision in the mediastinum or abdominal cavity. With the increasing number of DETTs performed worldwide, endoscopic tunnel therapeutics, which is based on DETT, has been gradually developed and optimized. However, there is not yet an expert consensus on DETT to regulate its indications, contraindications, surgical procedure, and postoperative treatment. The International DETT Alliance signed up this consensus to standardize the procedures of DETT. In this consensus, we describe the definition, mechanism, and significance of DETT, prevention of infection and concepts of DETT-associated complications, methods to establish a submucosal tunnel, and application of DETT for lesions in the mucosa, in the MP and outside the GI tract (indications and contraindications, procedures, pre- and postoperative treatments, effectiveness, complications and treatments, and a comparison between DETT and other operations).