Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication following ERCP, and its prevention remains a major concern for biliopancreatic endoscopists. This umbrella review aims to assess existing meta-analytic evidence on the effectiveness of pharmacological interventions (PIs) and procedural technical modifications (PTMs) in reducing the incidence and severity of PEP. We searched multiple databases to identify meta-analyses of randomized controlled trials (RCTs) that assessed the impacts of PIs or PTMs on the incidence and severity of PEP, from database inception to September 24, 2024. Evidence credibility was classified based on pre-specified criteria as: convincing (Class I), highly suggestive (Class II), suggestive (Class III), weak (Class IV), or non-significant evidence. Furthermore, the GRADE approach was employed to assess the quality of the evidence, categorizing it into four levels: high, moderate, low, and very low. A review of 47 meta-analyses (137,391 participants; 25 on PIs, 22 on PTMs) identified five PIs with suggestive evidence for PEP prevention: indomethacin (odds ratio [OR] 0.52, 95
Aims: ERCP training should adapt to the rapid development of ERCP technology and indications. China has a large population and vast land area, but ERCP training resources are insufficient. To make effective use of scarce ERCP training resources, the Standardized Training for ERCP Procedure (STEP) program was launched as a pilot trial. We aimed to report the graduation and competence situations and analyze the predictive factors. Methods: This was a prospective multicenter study from January 2015 to May 2021 containing 2 stages: the training program stage and the graduate questionnaire survey stage. The graduation and competence rates were investigated and analyzed. Results: In the training stage, 146 trainees completed the training, 113 (77.4%) graduated. The gender ratio (men vs. women) was 6.7:1. The mean age was 40.14±4.13 years. In total, 11 trainees failed the institutional mentored training phase (IMTP), 18 failed the practice strengthen training phase (PSTP), and 4 failed the comprehensive theoretical test. In the questionnaire survey stage, the response rate was 92%, of which 76.9% (80/104) achieved competence. ERCP cases performed independently in IMTP (OR=1.129, P=0.025) and ERCP volume in training years (OR=1.018, P=0.026) were predictive factors for graduation. Job title (senior physician) (OR=78.811, P=0.018) and main practice form of PSTP (independently) (OR=17.062, P=0.031) were predictive factors for competence in available graduates. Conclusions: The STEP achieved an acceptable graduation and competence rate. We gained valuable experience in framework organization and multiple assessment checkpoints. Therefore, this standardized training model is suitable for developing countries with rapid progress in ERCP.
Background and Objectives: Gastric outlet obstruction impedes gastric emptying into the duodenum. Although EUS-guided gastroenterostomy (EUS-GE) provides a minimally invasive therapeutic option, current techniques are limited by significant constraints. This study evaluated the safety and efficacy of direct EUS-GE (DGE) compared with a novel balloon-assisted EUS-GE (NBAGE). Methods: This multicenter retrospective cohort study enrolled patients who underwent EUS-GE in 4 high-volume tertiary Chinese referral centers from June 2023 to December 2025. Forty-six patients with DGE and 55 patients with NBAGE were included. Technical and clinical success rates, procedural time, adverse events, injection volume, postoperative length of stay, and mortality were compared. Results: Among 101 patients, NBAGE had significantly higher technical success as compared with DGE (100% vs. 87.0%, P = 0.007). Clinical success was similar between groups (95% vs. 96.4%, P = 1.0). The mean procedural time was similar between DGE and NBAGE (32 vs. 30.4 min, P = 0.564). Thirty-day adverse events occurred in 5 of 40 patients (12.5%) in the DGE group versus 1 of 55 patients (1.8%) in the NBAGE group ( P = 0.079). NBAGE required significantly less injection volume (101 vs. 647 mL, P < 0.001). Postoperative length of stay did not differ significantly (5 vs. 4 days, P = 0.124). The mortality rate was 0% in both groups. Conclusion: NBAGE was associated with significantly higher technical success with substantially reduced injection volume, providing a safe and effective alternative technique for EUS-GE.
Background and Objectives:Various lumen-apposing metal stents (LAMSs) were used for pancreatic fluid collection (PFC) drainage for many years. The structural design of LAMS needs to be improved to reduce the occurrence of adverse events. This trial assessed the efficacy and safety of a novel modified LAMS for the drainage of PFCs. Methods:This open-label, multicenter, prospective trial was done at 11 tertiary care hospitals. This study enrolled patients (18-75 years old) with confirmed diagnosis of PFC with cyst diameter no less than 6 cm. Novel LAMS (Micro-Tech Co, Ltd, Nanjing, China) was used. The primary end point was the 1-month postoperative drainage success rate. The secondary end points were technical success rate and adverse events. This study is registered with Chictr.org.cn, ChiCTR2000039955. Results:Between December 9, 2020, and December 27, 2021, 100 patients with PFC were assessed for eligibility, and 94 patients met the criteria and agreed to participate in the trial. The median size of PFC cyst was 11.23 ± 3.84 cm. The drainage success rate was 90.48% (95% CI, 83.6%-97.3%) and achieved the prespecified target value of 75% (P < 0.0001). In subgroup analysis, the clinical success rates of pancreatic pseudocyst (PPC) and walled-off necrosis (WON) were 95.45% and 85%, respectively (P = 0.143). The overall technical success rate was 98.94%. Postoperative early adverse events occurred in 57 (60.64%) of 94 patients, and late adverse events were encountered in 16 (17.02%) of 94 patients. The overall rate of serious adverse event (bleeding-related death) was 2.13% (2/94). Patients with WON had a significantly higher rate of early adverse events compared to those with PPC (77.78% vs. 44.90%, P = 0.001). Conclusions:The novel LAMS used in this trial was technically feasible, efficient, and safe for the treatment of PFCs. Comparable with WON, the usage of LAMS in PPC achieved a high drainage success rate and acceptable adverse events.
Insulinoma is a rare functional pancreatic neuroendocrine tumor characterized by excessive insulin secretion, which causes hypoglycemia. Recent advances in endoscopic technology have provided essential tools for the diagnosis and treatment of insulinoma. Early diagnosis and timely intervention, particularly endoscopy-guided intervention in selected patients, may improve clinical outcomes and quality of life. Although existing national and international guidelines mention insulinoma, standardized criteria for its endoscopic diagnosis and treatment remain lacking. Therefore, under the leadership of the Digestive Endoscopy Branch of the Chinese Medical Association, experts from related fields were invited to develop the Expert Consensus on Endoscopic Diagnosis and Treatment for Insulinoma (2026). The development process included a comprehensive review of recent national and international evidence-based literature, with the quality of evidence and strength of recommendations assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This consensus emphasizes endoscopy-guided diagnostic and therapeutic approaches. It aims to provide practical recommendations and operational guidance for standardized endoscopic diagnosis and treatment of insulinoma, thereby advancing the quality of endoscopic care for this condition in China.
In diagnosing type 1 autoimmune pancreatitis (AIP), serum IgG4 (sIgG4) can be false-negative. EUS-guided fine-needle aspiration/biopsy (EUS-FNA/FNB) pathology is key for diagnosis, but clinical features’ impact on pathologic confirmation is unclear. This study analyzed their link and factors improve diagnostic accuracy. We analyzed data from a single-center retrospective study at Changhai Hospital (Jan 2009-Jan 2024). Type 1 AIP was diagnosed per International Consensus Diagnostic Criteria (ICDC). Patients with surgical diagnosis, no EUS, or incomplete biopsy data were excluded; eligible cases were grouped into “Confirmed”/“Unconfirmed” per ICDC. Baseline data, laboratory indicators, imaging, and EUS-FNA/FNB data were collected. Statistical analyses (ROC, χ² tests, multivariate logistic regression) were done with R 4.4.0. A total of 182 suspected type 1 AIP patients were enrolled; 84.07
Background and Objectives:Repeated EUS-guided fine-needle aspiration/biopsy (rEUS-FNA/B) is recommended in solid pancreatic lesions (SPLs) with inconclusive initial results. However, even rEUS-FNA/B cannot completely eliminate false negatives in challenging cases. This study aims to identify risk factors of false-negative results in rEUS-FNA/B and develop a prediction model. Methods:Data of patients who had an initial inconclusive diagnosis and underwent rEUS-FNA/B for SPLs across 8 Chinese medical centers from January 2013 to June 2024 were retrospectively reviewed. Logistic regression was performed to identify the risk factors of false-negative results in rEUS-FNA/B. A clinical prediction model using a random forest algorithm was developed with leave-one-hospital-out cross-validation. Results:A total of 230 patients were enrolled in this study. Among them,159 patients (69.1%) were diagnosed with malignancies, while 71 patients (30.8%) had benign lesions. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of rEUS-FNA/B was 78.26%, 68.55%, 100%, 100%, and 58.68%. At multivariate analysis, lesion size 20-40 mm (odds ratio [OR] 0.26), lesion size ≥40 mm (OR 0.20), ≤2 needle passes (OR 3.1), and no liquid-based cytology (LBC) examination (OR 3.95) were found to be independently associated with false-negative results. A final random forest model with 4 features (lesion size, rEUS-FNA/B needle type, LBC, and smear cytology) showed moderate ability to distinguish false-negative results in both training (area under the receiver operating characteristic curve = 0.78) and validation sets (area under the receiver operating characteristic curve = 0.68). Conclusion:To minimize false-negative outcomes during rEUS-FNA/B, LBC is strongly recommended. Additionally, SPLs with a maximum diameter of ≤20 mm exhibit a higher probability for producing false-negative results during rEUS-FNA/B procedures.
Background and ObjectivesAutoimmune pancreatitis is a distinct type of pancreatitis mediated by autoimmune processes. Imaging studies frequently reveal diffuse or focal pancreatic enlargement, as well as irregular narrowing of the pancreatic duct. The clinical manifestations of this condition often overlap with those of other malignant conditions, such as pancreatic cancer, which can result in a high rate of misdiagnosis. EUS-guided fine-needle aspiration biopsy is a novel approach for the pathological diagnosis of AIP, enabling pancreatic tissue sampling. However, there remains a paucity of research on the efficacy of EUS-guided tissue sampling in the diagnosis of suspected AIP. The objective of this study is to assess the diagnostic value of EUS-guided tissue acquisition (including EUS-FNA and EUS-FNB) in patients with suspected AIP.MethodPatients suspected of AIP who underwent EUS-guided tissue acquisition (EUS-TA) at Changhai Hospital between 2010 and 2025.ResultsThis study included 148 patients with suspected AIP. Ultimately, 131 were diagnosed with AIP, 9 with pancreatic malignancy, and 8 with other pancreatic diseases. Among the 131 patients diagnosed with AIP, EUS-TA achieved a success rate of 88.66% for obtaining histopathological evidence in type 1 AIP, 76.47% in type 2 AIP, and 85.5% overall for AIP. The ROC curve indicates that EUS-TA demonstrates good diagnostic value for patients suspected of having AIP (AUC = 0.839, 95% CI: 0.729-0.95). Compared with EUS-FNB, EUS-FNA showed significantly lower sensitivity (78.57% vs. 90.67%, P = 0.029), specificity (75% vs. 88.89%, P = 0.017), negative predictive value (33.33% vs. 53.3%, P = 0.007), and accuracy (78.13% vs. 90.48%, P = 0.034).ConclusionEUS-guided tissue acquisition demonstrates good diagnostic value for patients suspected of AIP, with EUS-FNB showing higher diagnostic value for AIP than EUS-FNA. EUS-FNB is the preferred diagnostic method for patients suspected of AIP.
Objective: In type 1 autoimmune pancreatitis (AIP), serum immunoglobulin G4 (IgG4) has a complex correlation with pathology. In this study, clinical/histopathological traits of serum IgG4-negative/positive (N/P) patients were compared, and serum IgG4-tissue IgG4 correlations were explored to aid accurate diagnosis/typing. Material and Methods: A retrospective analysis was performed on 78 type 1 AIP patients (screened from 160 eligible cases through inclusion/exclusion criteria, International Consensus Diagnostic Criteria-confirmed at Changhai Hospital (December 2019-2023). At diagnosis, patients with serum IgG4 <135 mg/dL (n = 19) were assigned to the serum IgG4-N group, and those with serum IgG4 ≥135 mg/dL (n = 59) were assigned to the serum IgG4-P group. Clinical baseline data, laboratory indicators, imaging features (computed tomography/magnetic resonance imaging/endoscopic ultrasound guided [EUS]), and histopathological findings (from EUS fine-needle aspiration/fine-needle biopsy [EUS-FNA/FNB] or surgery) were compared. Statistical analysis (R 4.4.0) was conducted with Chi-square/Fisher’s exact tests (categorical data) and Mann‒Whitney U tests (continuous data); Spearman correlation was used to assess serum IgG4-tissue IgG4 links. A Bonferroni-corrected P <0.050 was considered to indicate statistical significance. Results: No significant differences in sex, age, most comorbidities (e.g., hypertension), or symptoms (e.g., abdominal discomfort) were observed between the serum IgG4-N and serum IgG4-P groups (all P > 0.050). The rate of bile duct stenosis was higher in the serum IgG4-P group than in the serum IgG4-N group (55.93% vs. 26.32%, P = 0.047), as were the rates of EUS examination (84.75% vs. 52.63%, P = 0.010), EUS-FNA/FNB (84.75% vs. 52.63%, P = 0.010). The 84.75% vs 52.63% ( P = 0.010) represents the EUS examination receiving rate between serum IgG4-P and serum IgG4-N groups, rather than the diagnostic positive rate of FNA/FNB subtypes. The serum IgG4-P group also had a higher histopathological confirmation rate (71.19% vs. 36.84%, P = 0.015) and a greater median number of tissue IgG4-P cells (36 vs. 8 cells per high-power field (HPF), P = 0.035). In contrast, the serum IgG4-N group had a higher median carbohydrate antigen 19-9 (CA19-9) level (32.14 vs. 5.97 U/mL, P = 0.035), a higher rate of long/multiple pancreatic duct narrow sections (30% vs. 2%, P = 0.013), and a higher surgical rate (47.37% vs. 15.25%, P = 0.010). Across both groups, no significant correlation was detected between serum IgG4 levels and tissue IgG4-P plasma cell counts (Spearman’s rho = 0.113, P = 0.322; linear regression coefficient = 0.004, P = 0.538). Conclusion: Serum IgG4 typing is associated with the clinical-pathological features of type 1 AIP. The serum IgG4-P group often shows biliary duct stenosis and diffuse pancreatic enlargement, with a reliance on EUS puncture. The serum IgG4-N group has higher CA19-9 and a higher surgical rate. Pathological examination remains critical (no serum-tissue IgG4 association). This study supports optimized, accurate diagnosis and stratified management of type 1 AIP.
Background and Aims: ERCP training should adapt to the rapid development of ERCP technology and indications. China has a large population and vast land area, but ERCP training resources are insufficient. To make effective use of scarce ERCP training resources, the Standardized Training for ERCP Procedure (STEP) program was launched as a pilot trial. We aimed to report the graduation and competence situations and analyze the predictive factors. Methods: This was a prospective multicenter study from Jan 2015 to May 2021 containing 2 stages: the training program stage and the graduate questionnaire survey stage. The graduation and competence rates were investigated and analyzed. Results: In training stage, 146 trainees completed the training, 113 (77.4%) graduated. The gender ratio (men vs. women) was 6.7:1. The mean age was 40.14±4.13 years. In total, 11 trainees failed institutional mentored training phase (IMTP), 18 failed the practice strengthen training phase (PSTP), and 4 failed the comprehensive theoretical test. In the questionnaire survey stage, the response rate was 92%, of which 76.9% (80/104) achieved competence. ERCP cases performed independently in IMTP (OR=1.129, p=0.025) and ERCP volume in training years (OR=1.018, p=0.026) were predictive factors for graduation. Job title (chief doctor) (OR=78.811, p=0.018) and main practice form of PSTP (independently) (OR=17.062, p=0.031) were predictive factors for competence in available graduates. Conclusions: The STEP achieved an acceptable graduation and competence rate. We gained valuable experience in framework organization and multiple assessment checkpoints. Therefore, this standardized training model is suitable for developing countries with rapid progress in ERCP. Funding: None Declaration of Interest: The STEP program was supported by Boston Scientific Corporation. All funds were independently managed by the organization of STEP program, and Boston Scientific Corporation did not involve in the program. All the authors have no financial relationship that can inappropriately influence this study. None of authors was employee of Boston Scientific Corporation. Ethical Approval: Because this study only involves the questionnaire survey of the trainees and with observational aim, and no patients involved directly in the study, research ethics approval was exempted.
Background and Objective:The optimal timing between endoscopic retrograde cholangiopancreatography (ERCP) and EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) remains undefined. This study compared The optimal timing between endoscopic retrograde cholangiopancreatography (ERCP) and EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) remains undefined. This study compared the safety and efficacy of same-day versus separate-day procedures.the safety and efficacy of same-day versus separate-day procedures. Methods:We conducted a retrospective analysis of 362 patients with pancreatic mass and biliary obstruction who underwent EUS-FNA/B and ERCP during one hospitalization period at Changhai Hospital between January 2017 and February 2024. Outcomes included adverse events, technical success of biliary stenting, and diagnostic yield of EUS-FNA/B. Logistic regression identified risk factors for adverse events. Results:Patients were stratified into same-day (group A, n = 60) and separate-day (group B, n = 302) groups. No perforations occurred in either group. Rates of pancreatitis (10.0% vs. 9.3%), infection (10.0% vs. 8.3%), and bleeding (1.7% vs. 3.7%) were comparable (all P > 0.05). Technical success of biliary stenting (96.7% vs. 96.7%) and diagnostic yield of EUS-FNA/B (80.0% vs. 84.8%) showed no intergroup differences. Notably, same-day procedures significantly shortened median hospital stay (6 [4-8.75] days vs. 7 [6-10] days, P = 0.002). Multivariable analysis identified advancing age (odds ratio [OR]: 0.957; 95% confidence interval [CI], 0.924-0.991; P = 0.014) and larger mass short-axis diameter (OR: 0.918; 95% CI, 0.868-0.971; P = 0.003) as independent protective factors against pancreatitis, while overweight status (body mass index > 23.9 kg/m2) increased pancreatitis risk (OR: 3.491; 95% CI, 1.574-7.744; P = 0.002). Precut sphincterotomy was independently associated with bleeding risk (OR: 1.607; 95% CI, 1.230-20.242; P = 0.024). Crucially, the same-day procedure was not linked to increased adverse events. Conclusion:Same-day ERCP and EUS-FNA/B is safe and feasible, does not increase adverse events, and reduces hospital stay.
In the research on the pathogenesis of post-acute pancreatitis diabetes mellitus (PPDM-A), abnormal bidirectional communication between pancreatic acinar cells (PACs) and islet cells is a key focus. However, immortalized cell lines cannot replicate pathophysiological conditions, making the extraction of high-quality primary cells crucial. Current methods for extracting primary islets from mice mostly rely on in-vivo pancreatic perfusion via bile duct cannulation, which has a high technical barrier and is not conducive to operation by researchers without experience. This study modified the method, eliminating the need for complex, in-vivo perfusion. SPF-grade C57BL/6J mice (6-8-week-old) were anesthetized and euthanized, followed by pancreas isolation. The pancreas was digested in vitro with collagenase P; primary islets were separated via Ficoll density gradient centrifugation, and acinar cells were obtained through cell sieve filtration and centrifugation. Cell viability and function were evaluated using calcein/propidium iodide (Calcein/PI) staining, glucose-stimulated insulin secretion assay, and amylase activity detection. The results showed that the modified method was easy to operate: the yield per mouse was (120 ± 5) primary islets and 1.6-1.95 × 10⁷ acinar cells; the viability rates of islets and acinar cells were (97.52 ± 0.16)% and (96.55 ± 0.95)%, respectively. Moreover, the islets exhibited normal insulin secretion ability, and the acinar cells were sensitive to cerulein stimulation. This method is simple and reliable, providing a feasible framework for studying pancreatic exocrine-endocrine interactions and PPDM-A. However, it has limitations, such as an unvalidated application in rats.
INTRODUCTION:The learning process for probe-based confocal laser endomicroscopy (pCLE) is challenging, and standardized training protocols are currently lacking. The main purpose of this study was to establish and evaluate a preliminary pCLE training system. METHODS:This prospective diagnostic trial was performed based on the nationwide training program. The training system included online theoretical courses and a 2-day offline training. All patients underwent pCLE and magnifying endoscopy (ME). The diagnostic performances of baseline levels, pCLE trainees, pCLE experts, and ME experts were evaluated and compared. The primary outcomes were the diagnostic accuracy, sensitivity, and specificity of gastric cancerous lesions. Linear regression analysis was adopted to explore the influence factors on the accuracy of trainees. RESULTS:A total of 150 lesions and 127 endoscopists were enrolled. All diagnostic indicators for pCLE trainees exhibited significant improvement versus baseline levels (all P < 0.001). pCLE trainees exhibited significantly lower accuracy than pCLE experts ( P = 0.036). There were no significant differences in accuracy, sensitivity, and specificity between pCLE trainees and ME experts. pCLE experts showed significantly higher accuracy ( P = 0.039) and specificity ( P = 0.022) than ME experts. Professional title, hospital level, gastroscopy experience, ME experience, and educational degree exerted no significant influence on the accuracy of pCLE trainees. DISCUSSION:Short-term systematic pCLE training demonstrated significant efficacy, and the diagnostic performance of pCLE trainees was comparable with that of mature ME technology. pCLE can serve as an effective method to promptly enhance the diagnostic proficiency of endoscopists, especially novices, for gastric cancerous lesions.
OBJECTIVES:Previous research has conducted meta-analyses on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). However, studies on adverse events (AEs) have been limited and sporadic and have included a highly diverse group of patients (with upper and lower gastrointestinal tract issues) and needles of varying sizes (19-22-25G). The purpose of this systematic review and meta-analysis was to determine the incidence of AEs related to the utilization of 20-22G second-generation EUS-FNB needles subsequent to puncture of the upper gastrointestinal tract and adjacent organs. METHODS:We searched the PubMed, Embase, and SCIE databases from January 1, 2010, to December 31, 2023. The primary outcome was percentage of summary AEs. Subgroup analyses were based on needle type, needle size, and lesion site. RESULTS:A total of 99 studies were included in the analysis, with 9303 patients. The overall AE rate for 20-22G second generation EUS-FNB needles in upper gastrointestinal EUS-FNB was 1.8% (166/9303), with bleeding being the most common AE at 44.0%. The percentages of pancreatitis, abdominal pain, and other AEs were 24.1%, 21.1%, and 10.8%, respectively. Patients undergoing hepatic EUS-FNB had the highest incidence of AEs at 14.0%, followed by submucosal lesions at 3.2% and pancreatic lesions at 2.6%. CONCLUSION:EUS-FNB is a safe procedure with a relatively low risk of upper gastrointestinal AEs (1.8%) and no associated deaths. Postoperative bleeding and pancreatitis are the most common complications of EUS-FNB. Most AEs are mild and self-limiting in severity, and serious complications are very rare.
In recent years, EUS-guided biliary drainage has been widely implemented in China, and standardization of this procedure has become an urgent matter. As EUS-guided biliary drainage technology and accessories continue to advance, the understanding of its clinical benefits and complications is also evolving. This expert consensus summarizes the current evidence and presents 12 clinical questions and 40 recommendations in the form of questions and answers regarding indications and contradictions, techniques, accessory selection, complications, perioperative management, and learning and training. The goal of this consensus is to assist in decision-making and standardize the treatment process.