BackgroundThe Trans.IT database is a national gastrointestinal (GI) endoscopy database developed in 2012. It automatically collects anonymous data from GI endoscopy procedures in a centralized database. All endoscopists use a structured reporting tool for uniform data collection. In this study, we aim to provide an overview of the database and to evaluate its impact on data registration quality.MethodsWe used all ERCPs, colonoscopies and colorectal cancer (CRC)-screening colonoscopies performed between 2016 and 2020. We excluded centers joining after 2016 and patients below age 18. Data registration quality for ERCPs included completeness of data for: intention of ERCP, Schutz score, ASA classification, papillary status (virgin or previous sphincterotomy), cannulation (success or failure to cannulate the desired duct) and procedural success. For colonoscopies: indication, ASA-classification, Boston Bowel Preparation Score (BBPS), cecal intubation, polyp detection rate (PDR). For CRC-screening colonoscopies, ASA-classification, BBPS, cecal intubation, PDR and adenoma detection rate (ADR).ResultsA total of 14,156 ERCPs, 150,962 colonoscopies and 37,199 colorectal cancer screening colonoscopies were included in our analysis. For ERCPs, registration of procedural intention, Schutz score, ASA classification, papillary status, cannulation and procedural success improved from 34.9%, 32.7%, 72.6%, 36.5%, 34.6%, 27.2% in 2016, to 86.4%, 84.6%, 97.4%, 86.4%, 82.1%, 84.0%, respectively, in 2020. For non-screening colonoscopies, registration of indication, ASA classification, BBPS, cecal intubation and PDR improved from 40.4%, 60.5%, 47.6%, 69.8% and 32.3% in 2016 to 90.3%, 88.9%, 59.8%, 79.1% and 39.1%, respectively, in 2020. For CRC-cancer screening colonoscopy registration equaled outcome, PDR and ADR changed from 74.7% to 63.6% in 2016 to 66.3% and 53.8% in 2020, respectively.ConclusionsThe quality of endoscopy data registration has consistently improved over the years by using the Trans.IT database. This is most likely the result of feedback to performing endoscopists to review performance in real-time online and progressive awareness of quality of data registration. image
Recently introduced hybrid 2-[18 F]-fluoro-2-deoxy-D-glucose (18 F-FDG) Positron Emission Tomography (PET) combined with Magnetic Resonance Imaging (MRI) may aid in proper diagnosis and staging of perihilar cholangiocarcinoma (pCCA). The aim of this study is to assess the effect of 18 F-FDG PET/MRI on diagnosis and clinical decision making in the pre-operative work up of pCCA. In this single-centre pilot study patients with presumed resectable pCCA underwent state-of-the-art 18 F-FDG hybrid PET/MRI using digital silicone photomultiplier detectors integrated within a 3-Tesla bore. Data were collected on several baseline and imaging characteristics. The primary outcome measure was the added diagnostic information and the effect on clinical decision making. Secondary aim was to correlate quantitative PET signal intensity to patient- and tumour characteristics. High and low SUVmax subgroups related to the mean value were made. Significance of lesion- and patient characteristics with the high and low SUVmax subgroups, as well as TLR and TBR, was evaluated with Fisher’s exact test or Mann-Whitney-U test. In total 14 patients were included (mean age 62.4 years, 64
Aims Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently develops in patients with gastric, duodenal, or pancreatic cancer. Recently, endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) with a lumen-apposing metal stent (LAMS) was proposed as a promising alternative to surgical gastroenterostomy or duodenal stent placement as treatment for malignant GOO. EUS-GE is a complex procedure, with a risk of complications such as LAMS misdeployment, perforation, or peritonitis. Therefore, it is important to identify patient and disease characteristics that influence outcomes after EUS-GE to (de)select patients for this procedure. The present study evaluated considered risk factors for technical and clinical success, such as biliary obstruction, ascites, and peritoneal carcinomatosis.
Abstract Background Preoperative biliary drainage is required in the majority of patients with resectable perihilar cholangiocarcinoma (pCCA). Most centres use plastic stents rather than uncovered self-expanding metal stents (uSEMS) because of the potential difficulties associated in removing uSEMS. In the palliative setting, however, uSEMS are associated with superior patency and even improved survival. The aim of this study is to compare the utility of uSEMS versus plastic stents in the pre-operative drainage of patients with resectable pCCA. Methods In this retrospective, multicentre, international cohort study, all consecutive patients with a high suspicion of resectable pCCA who underwent an initial endoscopic biliary drainage with uSEMS or plastic stent between 2010–2020 were included. Analyses were stratified by groups according to initial stent type. The primary outcome was stent failure, which was a composite endpoint of cholangitis and/or re-intervention due to biliary complications or inadequate biliary drainage. Propensity score matching (1:1) was performed to adjust for age, gender, primary sclerosing cholangitis, Bismuth classification, WHO performance status and ASA classification. Results A total of 474 patients with successful initial stent placement were included. Of these patients 61 received uSEMS and 413 plastic stents. Matching resulted in two groups of 59 patients. Stent failure occurred significantly less in the uncovered uSEMS group (31% vs 64%, P<0.001) and resulted in a significant reduction in the number of repeat ERCP procedures (14% vs 54%, P<0.001). Despite this the number of patients eventually required percutaneous transhepatic biliary drainage was similar (9% vs 7%, P=1). uSEMS placement was also associated with a reduction in episodes of cholangitis (15% vs 31%, P=0.012), although other ERCP and stent related complications did not differ. The number of patients ultimately undergoing surgical resection was not significantly different (81% vs 90%, P=0.19) between groups with uSEMS removal during surgery successful in all patients. The median overall survival after initial stent placement was 482 days [95% CI, 338–787] in the uSEMS group and 429 [95% CI, 263–881] in the plastic stent group (log-rank P=0.81). Survival after surgical resection was similar and post-operative outcomes also comparable: R1 resections (58% vs 59%, P=0.569), complications according to Clavien-Dindo (P=0.227), and hepatico-jejunostomy associated complications (leak: 4% vs 14%, P=0.393, stricture: 15% vs 21%, P=0.822). Conclusions Stent failure occurred significantly less often in uSEMS group resulting in fewer drainage procedures and reduced episodes of cholangitis. Removal of uSEMS during surgery was feasible and surgical outcomes were comparable. Although preoperative biliary drainage by uSEMS shows promising results further study is warranted and multicentre randomized controlled trials with a clear treatment strategy should be performed.
Introduction: Although antibiotic treatment is one of the cornerstones of management of (suspected) infected necrotizing pancreatitis, indication, timing, duration and the type of antimicrobial regimes is still debated and vary. Methods: We performed a post-hoc analysis of a prospective multicenter cohort of 449 patients with necrotizing pancreatitis treated in 15 Dutch hospitals (2010 to 2019). Results on microbiological cultures and antimicrobial therapy were analysed. Results: Antimicrobial therapy was started in 369 (82%) of all patients with necrotizing pancreatitis, after a median of 5 (P25-P75: 1 – 14) days after admission. In 224/369 (70%) patients, the first antimicrobial therapy was started without a confirmed infection. Although carbapenems, specifically meropenem (n=75, 29%), were most frequently used as empirical antimicrobial therapy, Enterococcus faecium (which is intrinsically resistant to carbapenems) was frequently (24%) cultured in infected pancreatic necrosis. Multidrug-resistant bacteria were rare in the initial culture sample (2%), but increased to 14% in subsequent cultures. Empirical antimicrobial therapy started before the positive culture was appropriate in 64/128 patients (50%) with a positive pancreatic culture. In 87% of the patients with a culture that contained (partial) resistant bacteria the antibiotic regime was adjusted appropriately. Conclusion: In daily clinical practice, antimicrobial therapy are started early during necrotizing pancreatitis, mostly without a confirmed infection. E. faecium was the most frequently cultured microbe. Based on bacterial resistance and yeast involvement, empirically administered antibiotics often turn out inappropriate. Optimization of antimicrobial therapy has the potential to reduce unnecessary antibiotic use while improving clinical outcomes of patients with (infected) necrotizing pancreatitis.
Background: Surveillance of individuals at risk of developing pancreatic ductal adenocarcinoma (PDAC) has the potential to improve survival, yet early detection based on solely imaging modalities is challenging. Alternatively, individuals with lesions progressing to malignancy can be recognized by molecular biomarkers. We aimed to identify changes in serum protein glycosylation levels over time to earlier detect PDAC in high-risk individuals undergoing surveillance.Methods: Individuals with a hereditary predisposition to develop PDAC were followed in two surveillance programs and we included those of which at least two consecutive serum samples were available. Mass spectrometry analysis was performed to determine total N-glycome for each consecutive sample. Potentially discriminating N-glycans were selected based on our previous cross-sectional analysis (PDAC cases versus controls) and relative abundances were calculated for each glycosylation feature.Findings: 165 individuals (“FPC-cohort” N=119; Leiden cohort N=46) were included. In total, 97 (59%) individuals had a genetic predisposition (77 CDKN2A, 15 BRCA1/2, 5 STK11) and 68 (41%) a family history of PDAC without a known genetic predisposition (estimated >10-fold increased risk of developing PDAC). From each individual, a median number of 3 serum samples (IQR 3) was collected.Ten individuals (6%) developed PDAC during 35 months of follow-up. Upon comparison of these patients with all other individuals, several glycosylation characteristics were increased, namely fucosylation, tri- and tetra-antennary structures, and specific sialic linkage types. Other glycosylation characteristics decreased, such as complex-type diantennary and bisected glycans. The largest change over time was observed for tri-antennary fucosylated glycans, which were able to differentiate cases from controls with a specificity of 92%, sensitivity of 49% and accuracy of 90%.Interpretation: This study explores the applicability of serum N-glycan longitudinal monitoring for early detection in a pancreas surveillance program.Funding: The current study was supported by ZonNW project number 531002011 and Genootschap Bollenstreek – Bollenstreekfonds, Lisse-Hillegom, The Netherlands.Declaration of Interest: F.P. Vleggaar: Boston Scientific (Consultant) H.F., M.J Bruno: Boston Scientific (Consultant, support for industry and investigator-initiated studies), Cook Medical (Consultant, support for industry and investigator-initiated studies), Pentax Medical (Consultant, support for investigator-initiated studies), Mylan (Support for investigator-initiated studies), ChiRoStim (Support for investigator-initiated studies), all other authors have nothing to declare. Ethical Approval: The institutional ethical review boards of participating centers (2007_024, Amsterdam University Medical Center; MEC-2021-448 EMC; MEC P00.107 LUMC) have approved the study
Aims EUS-guided tissue acquisition is the most sensitive method to collect tissue samples of solid pancreatic lesions. The availability of clinical information might aid the pathologist’s ability to establish a diagnosis. The aim of this study was to investigate the diagnostic accuracy and agreement of cytotechnicians and pathologists in the evaluation of EUS-FNA samples of solid pancreatic lesions and the impact of clinical information on agreement and diagnostic accuracy.
Aims The ASGE has formulated three quality indicators (KPI) for EUS-guided TA according to a specific performance target (PT): rate of adequate sample (PT 85%), diagnostic yield of malignancy (PT 70%) and sensitivity for malignancy (PT 85%). Feedback on performance is provided to collaborating centers of the Dutch Quality in endosonography team (QUEST) annually using these KPIs. In this study we report the effect of implementation of a 3rd generation FNB needle in one of the collaborating community hospitals on KPIs.
Background and aims: Pancreatic cancer has a dismal prognosis. So far, imaging has been proven incapable of establishing an early enough diagnosis. Thus, biomarkers are urgently needed for early detection and improved survival. Our aim was to evaluate the pooled diagnostic performance of DNA alterations in pancreatic juice. Methods: A systematic literature search was performed in EMBASE, MEDLINE Ovid, Cochrane CENTRAL and Web of Science for studies concerning the diagnostic performance of DNA alterations in pancreatic juice to differentiate patients with high-grade dysplasia or pancreatic cancer from controls. Study quality was assessed using QUADAS-2. The pooled prevalence, sensitivity, specificity and diagnostic odds ratio were calculated. Results: Studies mostly concerned cell-free DNA mutations (32 studies: 939 cases, 1678 controls) and methylation patterns (14 studies: 579 cases, 467 controls). KRAS, TP53, CDKN2A, GNAS and SMAD4 mutations were evaluated most. Of these, TP53 had the highest diagnostic performance with a pooled sensitivity of 42% (95% CI: 31-54%), specificity of 98% (95%-CI: 92%-100%) and diagnostic odds ratio of 36 (95% CI: 9-133). Of DNA methylation patterns, hypermethylation of CDKN2A, NPTX2 and ppENK were studied most. Hypermethylation of NPTX2 performed best with a sensitivity of 39-70% and specificity of 94-100% for distinguishing pancreatic cancer from controls. Conclusions: This meta-analysis shows that, in pancreatic juice, the presence of distinct DNA mutations (TP53, SMAD4 or CDKN2A) and NPTX2 hypermethylation have a high specificity (close to 100%) for the presence of high-grade dysplasia or pancreatic cancer. However, the sensitivity of these DNA alterations is poor to moderate, yet may increase if they are combined in a panel. (c) 2022 The Authors. Published by Elsevier B.V. on behalf of IAP and EPC. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Introduction: Perforation and fistula of the gastrointestinal (GI)-tract may occur in necrotizing pancreatitis. Data from large unselected patient populations on the incidence, risk factors, clinical outcomes and treatment are lacking. Methods: We performed a post-hoc analysis of 896 patients with necrotizing pancreatitis, prospectively included in 23 Dutch hospitals (2005-2015). Multivariable logistic regression was used to explore risk factors and to adjust for confounders in comparing clinical outcomes of patients with or without perforation and fistula of the GI-tract. Results: GI-tract perforations and fistulas were identified in 139 (16%) patients, mostly in the duodenum (40%) and colon (64%). Independent risk factors were highest C-reactive protein within 48-hours after admission (OR 1.20 [95%-CI 1.02–1.41]), organ-failure in the first week (OR 2.81 [95%-CI 1.80–4.39]) and infected necrosis before diagnosis (OR 1.81 [95%-CI 1.11–2.97]). GI-tract perforation and fistula were associated with poor clinical outcomes, especially when the colon was affected. This is exemplified by an increase in prolonged ICU-stays (OR 6.64 [95%-CI 13.02–15.18]) and more invasive interventions (OR 4.54 [95%-CI 1.82-13.19]). Perforations and fistulas of the stomach and duodenum were treated conservatively in 66% and surgically in 8%. Colon perforations and fistulas were treated conservatively in 27% and surgically in 57%. Conclusions: Perforations and fistulas of the GI-tract occur in one in six patients with necrotizing pancreatitis and poorly affects clinical outcomes, especially colon perforations and fistulas. Risk factors are C-reactive protein within 48 hours, early organ-failure and infected necrosis. Overall, more than half of the patients are treated conservatively.
Aims Accurate assessment of the lymph node (LN) status is crucial in resectable perihilar cholangiocarcinoma (pCCA) to prevent major surgery in patients with LN metastases. This study investigates the added value of preoperative Endoscopic Ultrasound (EUS) with or without Tissue Acquisition (TA) compared to imaging for the detection of positive LNs in patients with resectable pCCA.
Aims Detection of clonal mutations may be of additional value for EUS-guided FNA. The amount of tissue on smears is often limited. Standard targeted next generation sequencing (NGS) approaches lack sensitivity to detect mutations in little material. The aim of this study was to investigate the diagnostic value of a NGS panel with unique molecular identifiers (UMI-NGS) on smears from solid pancreatic lesions with various cytological gradings according to the Bethesda criteria.
Aims Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (rNSAIDs) administration is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration may further reduce this risk. Guidelines already recommend aggressive hydration. However, multicentre randomised trials studying the added value of aggressive hydration in patients receiving prophylactic rNSAIDs are lacking. We, therefore, performed a trial to investigate the combination of aggressive hydration and rNSAIDs.
Gastric and colorectal cancer (CRC) are both one of the most common cancers worldwide. In many countries fecal immunochemical tests (FIT)-based CRC screening has been implemented. We investigated if FIT can also be applied for detection of H. pylori, the main risk factor for gastric cancer. This prospective study included participants over 18 years of age referred for urea breath test (UBT). Patients were excluded if they had used antibiotics/bismuth in the past 4 weeks, or a proton pomp inhibitor (PPI) in the past 2 weeks. Participants underwent UBT, ELISA stool antigen test in standard feces tube (SAT), ELISA stool antigen test in FIT tube (Hp-FIT), and blood sampling, and completed a questionnaire on user friendliness. UBT results were used as reference. A total of 182 patients were included (37.4% male, median age 52.4 years (IQR 22.4)). Of these, 60 (33.0%) tested H. pylori positive. SAT and Hp-FIT showed comparable overall accuracy 71.1% (95%CI 63.2–78.3) vs. 77.6% (95%CI 70.4–83.8), respectively (p = 0.97). Sensitivity of SAT was 91.8% (95%CI 80.4–97.7) versus 94.2% (95%CI 84.1–98.9) of Hp-FIT (p = 0.98). Serology scored low with an overall accuracy of 49.7% (95%CI 41.7–57.7). Hp-FIT showed the highest overall user convenience. FIT can be used with high accuracy and sensitivity for diagnosis of H. pylori and is rated as the most convenient test. Non-invasive Hp-FIT test is highly promising for combined upper and lower gastrointestinal (pre-) cancerous screening. Further research should investigate the clinical implications, benefits and cost-effectiveness of such an approach.
Aims The endoscopic step-approach is preferred over a surgical step-up approach in eligible patients with infected necrotizing pancreatitis. Lumen-apposing metal stents (LAMS) might optimize endoscopic drainage and reduce the need for endoscopic necrosectomy. Nevertheless, some safety concerns, particularly bleeding, remain. We conducted a multicenter prospective study to investigate the clinical outcome of LAMS in patients with infected necrotizing pancreatitis.
Pancreatic cystic neoplasms are increasingly detected in the general population. Although most of these lesions are benign, some are (pre)malignant and require follow-up or even surgical intervention. Three cases are presented and used to discuss the clinical implications of the renewed European Guideline on pancreatic cystic neoplasms in which relative and absolute indications for resection are proposed. In the first case, a pancreatic cystic lesion was found on abdominal ultrasound in a 77-year old female patient. After endoscopic ultrasound was performed, a serous cystic neoplasm was diagnosed without need for surveillance. In a 57-year old male, an abdominal MRI was performed to further assess an incidentally found pancreatic cystic lesion. Based on the MRI, a side-branch intraductal papillary mucinous neoplasm (SB-IPMN) was diagnosed and yearly surveillance was initiated. A 61-year old male underwent a laparoscopic distal pancreatectomy because of a mixed-type IPMN (MT-IPMN). The pathological results showed an IPMN with high-grade dysplasia.