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BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.
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BACKGROUND AND AIMS: Stent dysfunction is common after ERCP with self-expandable metal stent (SEMS) insertion for malignant distal biliary obstruction (MDBO). Chronic aspirin (acetylsalicylic acid; ASA) exposure has been previously shown to potentially decrease this risk. We aim to further ascertain the protective effect of ASA and to identify other predictors of stent dysfunction. METHODS: This multicenter retrospective cohort study was conducted at 9 sites in Canada and 1 in the United States. Patients with MDBO who underwent ERCP with SEMS placement between January 2014 and December 2019 were included and divided into 2 cohorts: ASA exposed (ASA-E) and ASA unexposed (ASA-U). Propensity-score matching (PSM) was performed to limit selection bias. Matched variables were age, sex, tumor stage, and type of metal stent. The primary outcome was the hazard rate of stent dysfunction. A multivariable Cox proportional hazards model was used to identify independent predictors of stent dysfunction. RESULTS: Of 1396 patients assessed, after PSM 496 patients were analyzed (248 ASA-E and 248 ASA-U). ERCP with SEMS placement was associated with a high clinical success of 82.2% in ASA-E and 81.2% in ASA-U cohorts (P = .80). One hundred eighty-four patients had stent dysfunction with a mean stent patency time of 229.9 ± 306.2 days and 245.4 ± 241.4 days in ASA-E and ASA-U groups, respectively (P = .52). On multivariable analysis, ASA exposure did not protect against stent dysfunction (hazard ratio [HR], 1.25; 95% confidence interval [CI], .96-1.63). An etiology of pancreatic cancer (HR, 1.36; 95% CI, 1.15-1.61) predicted stent dysfunction, whereas cancer therapy was protective (HR, .73; 95% CI, .55-.96). Chronic ASA use was not associated with an increased risk for adverse events including bleeding, post-ERCP pancreatitis, and perforation. CONCLUSIONS: In this large, multicenter study using PSM, chronic exposure to ASA did not protect against stent dysfunction in MDBO. Instead, the analysis revealed that the etiology of pancreatic cancer was an independent predictor of stent dysfunction and cancer therapy was protective.
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Colestasis , Neoplasias Pancreáticas , Stents Metálicos Autoexpandibles , Humanos , Aspirina/uso terapéutico , Colestasis/etiología , Colestasis/cirugía , Neoplasias Pancreáticas/patología , Puntaje de Propensión , Estudios Retrospectivos , Stents Metálicos Autoexpandibles/efectos adversos , Stents/efectos adversos , Resultado del Tratamiento , Masculino , FemeninoRESUMEN
Gastric antral vascular ectasia (GAVE) is characterized by red, angiomatous lesions in the antrum organized either in stripes or in a diffuse pattern that can be associated with upper gastrointestinal bleeding. Endoscopic band ligation (EBL) has been reported as an effective alternative therapy for patients with GAVE. Consecutive patients with a diagnosis of GAVE were prospectively followed while undergoing EBL every 2 months. Hemoglobin, ferritin, and iron levels were frequently recorded, and clinical follow-up was performed. A total of 21 patients with GAVE were enrolled, and 17 of these patients (81â%) had associated co-morbidities, most frequently cirrhosis and chronic renal failure. A clinical response was achieved in 19 patients (91â%). A significant improvement in the mean hemoglobin level was noted after EBL (Pâ<â0.001), and a significant decrease in blood transfusion requirements per month (Pâ=â0.001). No major complications were observed during the study period. The mean follow-up was 10 months. EBL is an effective and safe treatment for GAVE. Randomized, controlled trials comparing EBL with other endoscopic therapies are warranted.
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Ectasia Vascular Antral Gástrica/cirugía , Gastroscopía/métodos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Ligadura , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
Peroral cholangioscopy is useful in differentiating benign from malignant biliary strictures. However, when conventional biliary access via endoscopic retrograde cholangiopancreatography (ERCP) fails, percutaneous transhepatic cholangioscopy (PTCS) via the SpyGlass cholangioscopy system can be used to achieve a diagnosis. Four patients with biliary strictures in whom conventional ERCP was not possible and percutaneous brushings were either nondiagnostic or unsatisfactory were investigated with PTCS.âThe technique of PTCS involves insertion of the SpyGlass cholangioscope through a percutaneous transhepatic sheath, placed just prior to the procedure, to visualize the stricture and obtain biopsies with the SpyBite forceps. On the basis of our early observations, we conclude that PTCS using the SpyGlass cholangioscopy system for the assessment of biliary strictures is feasible, safe, and provides high diagnostic accuracy.
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Colestasis/diagnóstico , Endoscopía del Sistema Digestivo/métodos , Endoscopía del Sistema Digestivo/instrumentación , Humanos , Evaluación de Resultado en la Atención de Salud , Estudios RetrospectivosRESUMEN
BACKGROUND: A retrospective chart audit was performed to review biliary stent utilisation from January 2020 to January 2021. Non-guideline-based stent insertion was identified in 16% of patients with common bile duct (CBD) stones presenting for endoscopic retrograde cholangiopancreatography (ERCP). To improve this knowledge-practice gap, a quality improvement (QI) intervention was devised and trialled. AIM: To synchronise clinical indications for biliary stent insertion in patients with CBD stones in accordance with published guidelines. METHODS: Using a QI pre-post study design, chart audits were completed and shared with the ERCP team (n=6). Indication for biliary stent insertion was compared to published guidelines assessed by two reviewers independently (kappa statistic calculated). The QI intervention included an education session and quarterly practice audits. An interrupted time series with segmented regression was completed. RESULTS: A total of 661 patients (337 F), mean age 59±19 years (range 12-98 years), underwent 885 ERCPs during this postintervention period. Of 661 patients, 384 (58%) were referred for CBD stones. A total of 192 biliary stents (105 plastic, 85 metal) were placed during the first ERCP (192/661, 29%), as compared with the preintervention year (223/598, 37%, p=0.2). Furthermore, 13/192 stents (7%) were placed not in accordance with published guidelines (kappa=0.53), compared with 63/223 (28%) in the preintervention year (p<0.0001). A 75% reduction in overall avoidable stent placement was achieved with a direct cost avoidance of $C97 500. For the CBD stone subgroup, there was an 88% reduction in avoidable biliary stent placement compared with the preintervention year (8/384, 2% vs 61/375, 16%, p<0.0001). CONCLUSIONS: Education with audit and feedback supported the closing of a knowledge-to-practice gap for biliary stent insertion during ERCP, especially in patients with CBD stones. This has resulted in a notable reduction of avoidable stent placements and additional follow-up ERCPs and an overall saving of healthcare resources.
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Colangiopancreatografia Retrógrada Endoscópica , Cálculos Biliares , Mejoramiento de la Calidad , Stents , Humanos , Colangiopancreatografia Retrógrada Endoscópica/estadística & datos numéricos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Adulto , Cálculos Biliares/cirugía , Adolescente , Adulto Joven , Niño , Aceptación de la Atención de Salud/estadística & datos numéricos , Guías de Práctica Clínica como AsuntoRESUMEN
Background and Objectives: EUS-guided biliary drainage (EUS-BD) is a promising alternative to ERCP in malignant distal biliary obstruction (MDBO). Despite accumulating data, however, its application in clinical practice has been impeded by undefined barriers. This study aims to evaluate the practice of EUS-BD and its barriers. Methods: An online survey was generated using Google Forms. Six gastroenterology/endoscopy associations were contacted between July 2019 and November 2019. Survey questions measured participant characteristics, EUS-BD in different clinical scenarios, and potential barriers. The primary outcome was the uptake of EUS-BD as a first-line modality, without previous ERCP attempts, in patients with MDBO. Results: Overall, 115 respondents completed the survey (2.9% response rate). Respondents were from North America (39.2%), Asia (28.6%), Europe (20%), and other jurisdictions (12.2%). Regarding the uptake of EUS-BD as first-line treatment for MDBO, only 10.5% of respondents would consider EUS-BD as a first-line modality regularly. The main concerns were the lack of high-quality data, fear of adverse events, and limited access to EUS-BD dedicated devices. On multivariable analysis, lack of access to EUS-BD expertise was an independent predictor against the use of EUS-BD, odds ratio 0.16 (95% confidence interval, 0.04-0.65). In salvage situations following failed ERCP, most favored EUS-BD (40.9%) over percutaneous drainage (21.7%) in unresectable cancer. In borderline resectable or locally advanced disease, however, most favored the percutaneous approach due to fear of EUS-BD complicating future surgery. Conclusions: EUS-BD has not reached widespread clinical adoption. Identified barriers include lack of high-quality data, fear of adverse events, and lack of access to EUS-BD dedicated devices. Fear of complicating future surgery was also identified as a barrier in potentially resectable disease.
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Background and study aims Growing emphasis on quality and patient safety has supported the shift toward competency-based medical education for advanced endoscopy trainees (AETs). In this study, we aimed to examine Canadian AETs learning curves and achievement of competence using an ERCP assessment tool with strong evidence of validity. Methods This prospective study was conducted at five institutions across Canada from 2017-2018. Data on every fifth procedure performed by trainees were collected using the United Kingdom Joint Advisory Joint Advisory Group of Gastrointestinal Endoscopy (JAG) ERCP Direct Observation of Procedural Skills (DOPS) tool, which includes a four-point rating scale for 27 items. Cumulative sum (CUSUM) analysis was used to create learning curves for overall supervision ratings and ERCP DOPS items by plotting scores for procedures performed during training. Results Eleven trainees who were evaluated for 261 procedures comprised our sample. The median number of evaluations by site was 49 (Interquartile range (IQR) 31-76) and by trainee was 15 (IQR 11-45). The overall cannulation rate by trainees was 82â% (241/261), and the native papilla cannulation rate was 78â% (149/191). All trainees achieved competence in the "overall supervision" domain of the ERCP DOPS by the end of their fellowship.âTrainees achieved competency in all individual domains, except for tissue sampling and sphincteroplasty. Conclusions Canadian AETs are graduating from fellowship programs with acceptable levels of competence for overall ERCP performance and for the most specific tasks. Learning curves may help identify areas of deficiency that may require supplementary training, such as tissue sampling.
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BACKGROUND: Preliminary studies show promise for extrahepatic islet transplantation (ITx). However, clinical comparisons with intraportal ITx outcomes remain limited. METHODS: This single-center cohort study evaluates patients receiving extrahepatic or intraportal ITx between 1999 and 2018. Primary outcome was stimulated C-peptide level. Secondary outcomes were fasting plasma glucose, BETA-2 scores, and fasting C-peptide level. Multivariable logistic modeling evaluated factors independently associated with a composite variable of early graft failure and primary nonfunction within 60 d of ITx. RESULTS: Of 264 patients, 9 (3.5%) received extrahepatic ITx (gastric submucosal = 2, subcutaneous = 3, omental = 4). Group demographics were similar at baseline (age, body mass index, diabetes duration, and glycemic control). At 1-3 mo post-first infusion, patients receiving extrahepatic ITx had significantly lower stimulated C-peptide (0.05 nmol/L versus 1.2 nmol/L, P < 0.001), higher fasting plasma glucose (9.3 mmol/L versus 7.3 mmol/L, P < 0.001), and lower BETA-2 scores (0 versus 11.6, P < 0.001) and SUITO indices (1.5 versus 39.6, P < 0.001) compared with those receiving intraportal ITx. Subjects receiving extrahepatic grafts failed to produce median C-peptide ≥0.2 nmol/L within the first 60 d after transplant. Subsequent intraportal infusion following extrahepatic transplants achieved equivalent outcomes compared with patients receiving intraportal transplant alone. Extrahepatic ITx was independently associated with early graft failure/primary non-function (odds ratio 1.709, confidence interval 73.8-39 616.0, P < 0.001), whereas no other factors were independently predictive. CONCLUSIONS: Using current techniques, intraportal islet infusion remains the gold standard for clinical ITx, with superior engraftment, graft function, and glycemic outcomes compared with extrahepatic transplantation of human islets.
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Diabetes Mellitus Tipo 1 , Trasplante de Islotes Pancreáticos , Humanos , Trasplante de Islotes Pancreáticos/efectos adversos , Trasplante de Islotes Pancreáticos/métodos , Glucemia , Péptido C , Estudios de Cohortes , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/cirugíaRESUMEN
BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined. OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens. METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety. RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001). CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, 'runway time'), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.
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Bisacodilo/administración & dosificación , Catárticos/administración & dosificación , Ácido Cítrico/administración & dosificación , Colonoscopía/métodos , Compuestos Organometálicos/administración & dosificación , Fosfatos/administración & dosificación , Polietilenglicoles/administración & dosificación , Cuidados Preoperatorios/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cooperación del Paciente , Satisfacción del PacienteRESUMEN
BACKGROUND: Endoscopic ultrasound-guided transmural drainage is the preferred management of pancreatic fluid collections (PFCs). Optimizing drainage is important and there remains debate as to the choice of stent. A recent trend towards the use of lumen-apposing metal stents (LAMS) has emerged. AIM: To evaluate the performance characteristics of a LAMS based on a prospective protocol (CT scan 1 week after placement to assess for resolution and need for necrosectomy followed by stent removal within 3 weeks). METHODS: This is a descriptive prospective cohort study performed at a single centre. The primary outcome was clinical success. Secondary outcomes were technical success, procedure time, total number of endoscopic procedures with or without necrosectomy, stent indwell time, stent functionality and adverse events. RESULTS: Thirty-seven patients (21 males, mean age 46.5 years) underwent placement of LAMS for 41 PFCs (median size 12 cm). There were 18 pseudocysts and 23 walled-off necrosis. Clinical success was seen in 33 of 41 (80%) PFCs. Of the remaining eight patients, six underwent surgery and two patients died from underlying malignant disease (although their PFC had completely resolved). Technical success and stent functionality were 100%. The median procedure time was 14 min (interquartile range 11 min to 20 min). Of the 23 walled-off necrosis, 9 (39%) required necrosectomy. The median stent indwell time was 19 days (interquartile range 14 to 22 days). There were no serious adverse events. CONCLUSIONS: Our protocol demonstrates excellent performance characteristics of LAMS. Their clinical efficacy and favourable safety profile suggest that they may be the preferred modality for endoscopic ultrasound-guided management of PFCs.
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BACKGROUND: While most pancreatic fluid collections (PFCs) resolve spontaneously, endoscopic ultrasound-guided transluminal drainage (EUS-TD) may be necessary. EUS-TD has evolved from multiple double-pigtail plastic stents (DPPS) to fully covered self-expanding metal stents (FCSEMS) and lumen-apposing metal stents (LAMS). This study compares clinical attributes of DPPS, FCSEMS and LAMS. METHODS: This is a single-centre retrospective review of EUS-TD for PFCs. The primary outcome was clinical success. Secondary outcomes were technical success, procedure time, hospital length of stay (HLOS), number of endoscopies, need for necrosectomy, adverse events (AEs) and overall cost. RESULTS: Fifty-eight patients (37 male, average age 49 years) underwent a total of 60 EUS-TD procedures for PFCs (average size 11.2 cm with 29 pseudocysts and 29 walled-off necrosis). Ten patients (17%) underwent EUS-TD with DPPS and 48 patients (83%) with metal stents (32 FCSEMS, 16 LAMS). Overall technical and clinical success was 100% and 84%, respectively. Lumen-apposing metal stents had shorter procedure times (14.9 versus 63.6 DPPS, 39.1 min FCSEMS, P < 0.001), and no difference in AEs (3 of 16 versus 4 of 10 DPPS, 12 of 34 FCSEMS, ns). Double-pigtail plastic stents required more endoscopies (3.7 versus 2.3 LAMS, 2.3 FCSEMS, P = 0.013) and necrosectomies (4 of 10 [40%]) compared with 5 of 34 [15%] in the FCSEMS group and 3 of 16 [19%] in the LAMS group, respectively, P = 0.001) to achieve clinical resolution. The overall cost and HLOS was not significantly different between groups. CONCLUSION: The use of LAMS for PFCs is not associated with any significant increase in cost despite technical (shorter procedure time) and clinical advantages (shorter indwell time, reduced need for necrosectomy and no increase in AEs).
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BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the preferred modality for the cytological diagnosis of various cancers. Onsite cytopathology interpretation is not available in most centres. OBJECTIVE: To assess whether the the adequacy of tissue sampling assessed by an onsite cytotechnologist improves the diagnostic accuracy of EUS-FNA. METHODS: The present study is a retrospective review of all patients undergoing solid mass EUS-FNA between September 2005 and August 2007. Patients in group I (September 2005 to August 2006) had cytology slides prepared by an endoscopy nurse. Patients in group II (September 2006 to August 2007) had cytology slides prepared, stained and assessed for adequacy of tissue sampling by a cytotechnologist in the endoscopy suite. The final cytopathological diagnosis (definitely positive, definitely negative or inconclusive) was compared between the two groups. RESULTS: A total of 49 EUS-FNA procedures were performed in 47 patients in group I and 60 EUS-FNA procedures in 55 patients in group II. Pancreatic masses were the most common target site in both groups. The total number of needle passes was 105 in group I (mean 2.14 passes per patient; range one to five needle passes) and 158 in group II (mean 2.63 passes per patient; range one to four needle passes). The difference in the number of needle passes was not statistically significant between groups. The final diagnosis was definite in 53% in group I compared with 77% in group II (P=0.01). The percentage of inconclusive diagnoses was 47% in group I and 23% in group II (P=0.001). CONCLUSION: Onsite cytotechnologist interpretation of adequacy of tissue sampling significantly improves the diagnostic yield of EUS-FNA. This appears to be independent of the total number of needle passes undertaken for tissue sampling.
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Biopsia con Aguja Fina , Enfermedades del Sistema Digestivo/patología , Endosonografía , Servicio de Patología en Hospital/organización & administración , Sistemas de Atención de Punto , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Enfermedades del Sistema Digestivo/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: Acetylsalicylic acid (ASA) is used in the treatment of acute myocardial infarction (AMI) but is also a risk factor for peptic ulcer disease (PUD) bleeding. OBJECTIVE: To determine the factors associated with continued ASA use in patients with AMI who develop PUD bleeding. METHODS: AMI patients who developed PUD bleeding during the same hospitalization at two tertiary care hospitals in Edmonton, Alberta, between January 1999 and December 2006, were evaluated retrospectively. Multivariate analysis was used to determine predictors of the primary outcome of continued ASA use during PUD bleeding. RESULTS: A total of 102 patients were analyzed. Thirty-eight patients (37%) were continued on ASA, while 64 (63%) had ASA discontinued during their hospitalization. On multivariate regression analysis, significant predictors of continued ASA use included lowrisk ulcer stigmata on endoscopy (OR 3.7; 95% CI 1.4 to 10.2; P=0.01) and AMI requiring coronary intervention (OR 8.2; 95% CI 2.1 to 32.1; P=0.002). The mean (+/- SD) blood transfusion requirement was 3.9+/-3.6 units. The 30-day rebleeding and mortality rates were 14% and 14%, respectively. CONCLUSIONS: The continued use of ASA during AMI and PUD bleeding was variable. However, patients with low-risk ulcers and those who received coronary intervention were more likely to have ASA continued during PUD bleeding. Further studies evaluating the gastrointestinal risk of immediate ASA use in AMI with acute PUD bleeding are required.
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Aspirina/efectos adversos , Hemorragia Gastrointestinal/inducido químicamente , Infarto del Miocardio/tratamiento farmacológico , Úlcera Péptica/inducido químicamente , Inhibidores de Agregación Plaquetaria/efectos adversos , Anciano , Aspirina/administración & dosificación , Transfusión Sanguínea , Endoscopía del Sistema Digestivo , Femenino , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/mortalidad , Hemorragia Gastrointestinal/terapia , Humanos , Masculino , Úlcera Péptica/diagnóstico , Úlcera Péptica/mortalidad , Úlcera Péptica/terapia , Inhibidores de Agregación Plaquetaria/administración & dosificación , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Background and study aims Pseudocysts are the most common pancreatic cystic lesions and they usually develop in association with pancreatitis of at least 4 weeks' duration. Extra-pancreatic pseudocysts, although reported, are relatively uncommon. Secondary liver pseudocysts are recognized within the literature, and most patients described have required percutaneous or surgical drainage due to infection or symptoms. The mechanism of hepatic pseudocyst formation is not entirely clear but it is postulated that this phenomenon may occur through pseudocyst-portal vein fistulization. We describe two cases of patients presenting with pancreatic pseudocysts invading the portal venous system with embolization of pancreatic fluid to the liver and subsequent hepatic pseudocyst formation. Interestingly, liver pseudocyst resolution was incomplete with antibiotics and percutaneous drainage alone, and only occurred following endoscopic ultrasonography-guided pancreatic cyst-gastrostomy and metal stent insertion. We have reviewed the current literature on the diagnosis and management of pseudocyst-portal vein fistula formation and we believe that our cases represent the first published within the literature to describe this treatment approach.
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BACKGROUND & AIMS: Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. METHODS: The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. TRIAL REGISTRATION: Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
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Neoplasias de los Conductos Biliares/complicaciones , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colestasis/terapia , Drenaje/métodos , Endosonografía/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Stents , Ultrasonografía Intervencional/métodos , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Humanos , Método Simple Ciego , Stents/efectos adversosRESUMEN
BACKGROUND & AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) is associated with a risk of pancreatitis (PEP). Animal studies suggest that (single-dose) allopurinol (xanthine oxidase inhibitor with high oral bioavailability and long-lasting active metabolites) may reduce this risk; human study results are conflicting. The aim of this study was to determine if allopurinol decreases the rate of PEP. METHODS: Patients referred for ERCP to 9 endoscopists at 2 tertiary centers were randomized to receive either allopurinol 300 mg or identical placebo orally 60 minutes before ERCP, stratified according to high-risk ERCP (manometry or pancreatic therapy). The primary outcome (PEP) was adjudicated blindly; pancreatitis was defined according to the Cotton consensus, and evaluated at 48 hours and 30 days. Secondary outcomes included severe PEP, length of stay, and mortality (nil). The trial was terminated after the blinded (midpoint) interim analysis, as recommended by the independent data and safety monitoring committee. RESULTS: We randomized 586 subjects, 293 to each arm. The crude PEP rates were 5.5% (allopurinol) and 4.1% (placebo), (P = .44; difference = 1.4%; 95% confidence interval, -2.1% to 4.8%). The Mantel-Haenszel combined risk ratio for PEP with allopurinol, considering stratification, was 1.37 (95% confidence interval, 0.65-2.86). Subgroup analyses suggested nonsignificant trends toward possible benefit in the high-risk group, and possible harm for the remaining subjects. Logistic regression found pancreatic therapy, pancreatic injection, and prior PEP to be the only independent predictors of PEP. CONCLUSIONS: Allopurinol does not appear to reduce the overall risk of PEP; however, its potential benefit in the high-risk group (but potential harm for non-high-risk patients) means further study is required.
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Alopurinol/uso terapéutico , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Depuradores de Radicales Libres/uso terapéutico , Pancreatitis/prevención & control , Factores de Edad , Método Doble Ciego , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Pancreatitis/etiología , PremedicaciónAsunto(s)
Neoplasias Duodenales/complicaciones , Úlcera Duodenal/complicaciones , Úlcera Péptica Hemorrágica/complicaciones , Anciano , Neoplasias Duodenales/patología , Neoplasias Duodenales/cirugía , Úlcera Duodenal/patología , Úlcera Duodenal/cirugía , Humanos , Masculino , Úlcera Péptica Hemorrágica/patología , Úlcera Péptica Hemorrágica/cirugía , StentsRESUMEN
BACKGROUND: Endoscopic ultrasound (EUS) is accurate in diagnosing pancreatic neuroendocrine tumours (PNETs), but its impact on surgical management is unclear. OBJECTIVE: To determine whether preoperative EUS findings altered the decision for, and extent of, surgery in patients with PNETs. METHODS: A retrospective review of patients referred for EUS because of suspected PNETs was conducted. The diagnosis of PNETs was confirmed by EUS-guided fine needle aspiration cytology, where indicated, or by surgical histology. EUS findings were compared with computed tomography (CT) findings to determine whether there was an impact on the decision for surgical management. RESULTS: Fourteen patients (10 women), with a mean age of 44 years, underwent EUS for suspected PNETs. PNETs were seen with CT in 10 of 13 patients (77%) and with EUS in 14 of 14 patients (100%). One obese patient could not fit into the CT scanner. This patient had five PNETs on EUS. Three patients with a normal CT scan were determined to have one or two PNETs on EUS. Three patients with one or two PNETs on CT were found to have five to eight PNETs on EUS. EUS altered the decision for possible surgical management in five of 14 patients (36%), either by identifying a PNET or by finding multiple and multifocal PNETs that were not visualized on CT scans. CONCLUSION: EUS is useful in the preoperative assessment of PNETs by providing information that significantly influences the decision for surgical intervention or changes the extent of the planned surgery.
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Endosonografía/métodos , Tumores Neuroendocrinos/diagnóstico por imagen , Neoplasias Pancreáticas/diagnóstico por imagen , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tumores Neuroendocrinos/patología , Tumores Neuroendocrinos/cirugía , Obesidad/complicaciones , Neoplasias Pancreáticas/patología , Neoplasias Pancreáticas/cirugía , Cuidados Preoperatorios , Estudios Retrospectivos , Tomografía Computarizada por Rayos X/métodos , Adulto JovenRESUMEN
Background and study aims Cholangioadenoma is not recognized commonly and is often only diagnosed on surgical specimens. Direct per oral single-operator cholangioscopy (SOC) allows characterization of common bile duct (CBD) lesions through direct visualization and directed forceps biopsies with potential for impacting surgical management decisions. This is a retrospective review of all SOC cases diagnosed with cholangioadenoma. Patient demographics and outcomes were recorded. Three patients (all male), average age 68 years (range 62â-â76 years), were identified to have a cholangioadenoma. The clinical indication for SOC was deranged liver enzymes with a dilated CBD and a CBD abnormality identified on biliary imaging. The site of cholangioadenoma was proximal, mid and distal CBD, respectively. All patients had a successful SOC with targeted biopsy-proven diagnosis. One patient had a synchronous cholangiocarcinoma and underwent palliative stenting whereas the other two patients underwent appropriate curative resection based on cholangioadenoma location. We conclude that SOC is safe and effective for diagnosis of cholangioadenoma and has potential impact on decisions for surgical management.
RESUMEN
BACKGROUND: Common bile duct (CBD) stones are extracted with a basket or balloon during ERCP with sphincterotomy. However, some stones are difficult to extract by conventional means. Cholangioscopy with lithotripsy is a modality to treat these difficult stones. We describe the clinical efficacy of single-operator per oral cholangioscopy (SOPOC) for difficult stones and discuss cost savings by avoiding surgical intervention. METHODS: Retrospective chart review was performed for all patients referred for difficult CBD stones. Clinical success was defined as clearing the duct of all stones. The cost of cholangioscopy (in $CDN) was calculated by adding all costs associated with the procedure(s), surgery, hospital stay or treatment of adverse events. This cost was compared with the projected cost of surgical bile duct exploration. RESULTS: A total of 51 patients (35 female) with a mean age of 66 years underwent 58 SOPOC procedures. Median procedure time was 67 minutes (95% CI, 61.5-73.5). The CBD was successfully cleared in 47 of 51 patients (93%). Minor adverse events were seen in seven patients (14%). The actual average per procedure cost was $4555±$2647. This compares with a projected cost of $7766 and $6175 for open and laparoscopic bile duct exploration, with a cost-per-case saving of $3210 and $1619, respectively. CONCLUSION: SOPOC with lithotripsy is highly effective and safe for the treatment of difficult common bile duct stones. In addition, significant cost savings may be realized by avoiding surgical bile duct exploration.