The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction.

The first Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma were published in 2013. Since then, new evidence on the role of endoscopy for management of malignant hilar biliary obstruction (MHBO) has emerged. To update the recommendation, we reviewed the literature using a PICO (population/intervention/comparison/outcomes) framework and created consensus statements. The expert panel voted anonymously using the modified Delphi method and all final statements were evaluated for the quality of evidence and strength of recommendation. The important points with inadequate supporting evidence were classified as key concepts. There were seven statements and five key concepts that reached consensus. The statements and key concepts dealt with multiple aspects of endoscopy-based management in MHBO starting from diagnosis, strategies and options for biliary drainage, management of recurrent biliary obstruction, management of cholecystitis after biliary stenting, and adjunctive treatment before stenting. Although the recommendations may assist physicians in planning the treatment for MHBO patients, they should not replace the decision of a multidisciplinary team in the management of individual patients.

Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Precise mapping of hilar cholangiocarcinoma with a skip lesion by SpyGlass cholangioscopy: A case report.

BACKGROUND: Cholangiocarcinoma (CC) is a very aggressive cancer with a poor prognosis. As surgery is the only curative therapy, preoperative evaluation of the tumor extent is essential for surgical planning. Although high-quality image modalities such as computed tomography and magnetic resonance imaging have been used extensively in preoperative evaluation, the accuracy is low. To obtain precise localization of tumor spread arising from the hilar region preoperatively, the development of an acceptable imaging modality is still an unmet need. CASE SUMMARY: A 52-year-old female presented to our emergency department with jaundice, abdominal pain, and fever. Initially, she was treated for cholangitis. Endoscopic retrograde cholangiopancreatography with the cholangiogram showed long segment filling defect in the common hepatic duct with dilatation of bilateral intrahepatic ducts. Transpapillary biopsy was performed, and the pathology suggested intraductal papillary neoplasm with high-grade dysplasia. After treatment of cholangitis, contrasted-enhanced computed tomography revealed a hilar lesion with undetermined Bismuth-Corlette classification. SpyGlass cholangioscopy showed that the lesion involved the confluence of the common hepatic duct with one skip lesion in the posterior branch of the right intrahepatic duct, which was not detected by previous image modalities. The surgical plan was modified from extended left hepatectomy to extended right hepatectomy. The final diagnosis was hilar CC, pT2aN0M0. The patient has remained disease-free for more than 3 years. CONCLUSION: SpyGlass cholangioscopy may have a role in precision localization of hilar CC to provide surgeons with more information before the operation.

Consensus guidelines on the role of cholangioscopy to diagnose indeterminate biliary stricture.

BACKGROUND: Indeterminate strictures pose a therapeutic dilemma. In recent years, cholangioscopy has evolved and the availability of cholangioscopy has increased. However, the position of cholangioscopy in the diagnostic algorithm to diagnose malignancy have not been well established. We aim to develop a consensus statement regarding the clinical role of cholangioscopy in the diagnosis of indeterminate biliary strictures. METHODS: The international experts reviewed the evidence and modified the statements using a three-step modified Delphi method. Each statement achieves consensus when it has at least 80% agreement. RESULTS: Nine final statements were formulated. An indeterminate biliary stricture is defined as that of uncertain etiology under imaging or tissue diagnosis. When available, cholangioscopic assessment and guided biopsy during the first round of ERCP may reduce the need to perform multiple procedures. Cholangioscopy are helpful in diagnosing malignant biliary strictures by both direct visualization and targeted biopsy. The absence of disease progression for at least 6 months is supportive of non-malignant etiology. Direct per-oral cholangioscopy provides the largest accessory channel, better image definition, with image enhancement but is technically demanding. Image enhancement during cholangioscopy may increase the diagnostic sensitivity of visual impression of malignant biliary strictures. Cholangioscopic imaging characteristics including tumor vessels, papillary projection, nodular or polypoid mass, and infiltrative lesions are highly suggestive for neoplastic/malignant biliary disease. The risk of cholangioscopy related cholangitis is higher than in standard ERCP, necessitating prophylactic antibiotics and ensuring adequate biliary drainage. Per-oral cholangioscopy may not be the modality of choice in the evaluation of distal biliary strictures due to inherent technical difficulties. CONCLUSION: Evidence supports that cholangioscopy has an adjunct role to abdominal imaging and ERCP tissue acquisition in order to evaluate and diagnose indeterminate biliary strictures.

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry.

BACKGROUND: Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population. METHODS: This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first. RESULTS: 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy. CONCLUSION: In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.

International consensus statements for endoscopic management of distal biliary stricture.

Distal biliary strictures (DBS) are common and may be caused by both malignant and benign pathologies. While endoscopic procedures play a major role in their management, a comprehensive review of the subject is still lacking. Our consensus statements were formulated by a group of expert Asian pancreatico-biliary interventional endoscopists, following a proposal from the Digestive Endoscopy Society of Taiwan, the Thai Association for Gastrointestinal Endoscopy, and the Tokyo Conference of Asian Pancreato-biliary Interventional Endoscopy. Based on a literature review utilizing Medline, Cochrane library, and Embase databases, a total of 19 consensus statements on DBS were made on diagnosis, endoscopic drainage, benign biliary stricture, malignant biliary stricture, and management of recurrent biliary obstruction and other complications. Our consensus statements provide comprehensive guidance for the endoscopic management of DBS.

Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates.

BACKGROUND: Peroral cholangioscopy (POCS) can be useful for difficult bile duct stone clearance. Large prospective multinational data on POCS-guided lithotripsy for clearing difficult bile duct stones in a single session of endoscopic retrograde cholangiopancreatography (ERCP) are missing. METHODS: Patients with difficult bile duct stones (defined as one or more of: largest stone diameter ≥ 15 mm, failed prior attempt at stone clearance, impacted, multiple, hepatic duct location, or located above a stricture) were enrolled at 17 centers in 10 countries. The principal endpoint was stone clearance in a single ERCP procedure using POCS. RESULTS : 156 patients underwent 174 sessions of POCS-guided electrohydraulic or laser lithotripsy. Stone clearance had failed in a previous ERCP using traditional techniques in 124/156 patients (80 %), while 32 /156 patients (21 %) were referred directly to POCS-guided therapy based on preprocedural assessment of the difficulty of stone clearance. In 101/156 patients (65 %), there were impacted stones. POCS-guided stone clearance was achieved in a single POCS procedure in 125 /156 patients (80 %, 95 % confidence interval [CI] 73 % - 86 %), and was significantly more likely for stones ≤ 30 mm compared with > 30 mm (odds ratio 7.9, 95 %CI 2.4 - 26.2; P = 0.002). Serious adverse events occurred in 3/156 patients (1.9 %, 95 %CI 0.4 % - 5.5 %), and included pancreatitis, perforation due to laser lithotripsy, and cholangitis (n = 1 each), all resolved within 1 week. CONCLUSION: POCS-guided lithotripsy is highly effective for clearance of difficult bile duct stones in a single procedure and successfully salvages most prior treatment failures. It may also be considered first-line therapy for patients with difficult choledocholithiasis to avoid serial procedures.

Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia.

Concern has been raised regarding the use of simethicone, a de-foaming agent, during endoscopic procedures. Following reports of simethicone residue in endoscope channels despite high level disinfection, an endoscope manufacturer recommended that it not be used due to concerns of biofilm formation and a possible increased risk of microorganism transmission. However, a detailed mucosal assessment is essential in performing high-standard endoscopic procedures. This is impaired by bubbles within the gastrointestinal lumen. The Gastroenterological Society of Australia's Infection Control in Endoscopy Guidelines (ICEG) Committee conducted a literature search utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Following a review of the available evidence, and drawing on extensive clinical experience, the multidisciplinary ICEG committee considered the risks and benefits of simethicone use in formulating four recommendations. Published reports have documented residual liquid or crystalline simethicone in endoscope channels after high level disinfection. There are no data confirming that simethicone can be cleared from channels by brushing. Multiple series report benefits of simethicone use during gastroscopy and colonoscopy in improving mucosal assessment, adenoma detection rate, and reducing procedure time. There are no published reports of adverse events related specifically to the use of simethicone, delivered either orally or via any endoscope channel. An assessment of the risks and benefits supports the continued use of simethicone during endoscopic procedures. Strict adherence to instrument reprocessing protocols is essential.

Management of infected pancreatic necrosis in the setting of concomitant rectal cancer: A case report and review of literature.

BACKGROUND: Pancreatitis with infected necrosis is a severe complication of acute pancreatitis and carries with it high rates of morbidity and mortality. The management of infected pancreatic necrosis alongside concomitant colorectal cancer has never been described in literature. CASE SUMMARY: A 77 years old gentleman presented to the Emergency Department of our hospital complaining of ongoing abdominal pain for 8 h. The patient had clinical features of pancreatitis with a raised lipase of 3810 U/L, A computed tomography (CT) abdomen confirmed pancreatitis with extensive peri-pancreatic edema. During the course of his admission, the patient had persistent high fevers and delirium thought secondary to infected necrosis, prompting the commencement of broad-spectrum antibiotic therapy with Piperacillin/Tazobactam. Subsequent CT abdomen confirmed extensive pancreatic necrosis (over 70%). Patient was managed with supportive therapy, nutritional support and gut rest initially and improved over the course of his admission and was discharged 42 d post admission. He represented 24 d following his discharge with fever and chills and a repeat CT abdomen scan noted gas bubbles within the necrotic pancreatic tissue thereby confirming infected necrotic pancreatitis. This CT scan also revealed asymmetric thickening of the rectal wall suspicious for malignancy. A rectal cancer was confirmed on flexible sigmoidoscopy. The patient underwent two endoscopic necrosectomies and was treated with intravenous antibiotics and was discharged after 28 d. Within 1 wk post discharge, the patient commenced a course of neoadjuvant radiotherapy and subsequently underwent concomitant chemotherapy prior to undergoing a successful Hartmann's procedure for treatment of his colorectal cancer. CONCLUSION: This case highlights the efficacy of endoscopic necrosectomy, early enteral feeding and targeted antibiotic therapy for timely management of infected necrotic pancreatitis. The prompt resolution of pancreatitis permitted the patient to undergo neoadjuvant treatment and resection for his concomitant colorectal cancer.

Diabetes of the exocrine pancreas.

Diabetes of the exocrine pancreas (DEP) is a form of diabetes that occurs due to pancreatic disease. It is far more common than has been previously considered, with a recent study showing 1.8% of adults with new-onset diabetes should have been classified as DEP. The majority is misdiagnosed as type 2 diabetes mellitus (T2DM). Patients with DEP exhibit varying degrees of exocrine and endocrine dysfunction. Damage to the islet of Langerhans effects the secretion of hormones from the ß, α, and pancreatic polypeptide cells; the combination of low insulin, glucagon, and pancreatic polypeptide contributes to rapid fluctuations in glucose levels. This form of "brittle diabetes" may result in the poorer glycemic control observed in patients with DEP, when compared with those with T2DM. Diabetes of the exocrine pancreas has a different natural history to other forms of diabetes; patients are more likely to require early insulin initiation compared with those with T2DM. Therefore, individuals with DEP should be advised about the symptoms of decompensated hyperglycemia, although they are less likely to develop ketoacidosis. Clinicians should screen for DEP in patients with acute or chronic pancreatitis, following pancreatic resection, or with co-existing cystic fibrosis or hemochromatosis. Incident diabetes may herald the onset of pancreatic ductal carcinoma in a small subset of patients. Once identified, patients with DEP can benefit from specific lifestyle advice, pancreatic enzyme replacement therapy, metformin treatment, appropriate insulin dosing, and monitoring. Further research is needed to establish the ideal treatment regimens to provide optimal clinical outcomes for this unique form of diabetes.

Australian infection control in endoscopy consensus statements on carbapenemase-producing Enterobacteriaceae.

Outbreaks of carbapenemase-producing Enterobacteriaceae clinical infections related to endoscopic transmission are well documented. The high morbidity and mortality associated with these infections emphasizes the need to reassess endoscopic reprocessing protocols. The Gastroenterological Society of Australia established a multi-society committee to formulate evidence-based consensus statements on the prevention and management of endoscopic transmission of carbapenemase-producing Enterobacteriaceae. A literature search was undertaken utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Nine statements were formulated. Using the Delphi methodology, the statements were initially reviewed electronically by the committee members and subsequently at a face-to-face meeting in Melbourne, Australia. After further discussion, four additional sub-statements were added resulting in a total of 13 statements. Each statement was assessed for level of evidence, recommendation grade and the voting on recommendation was recorded. For a statement to be accepted, five out of six committee members had to "accept completely" or "accept with some reservation." All 13 statements achieved consensus agreement. Eleven statements achieved 100% "accepted completely." Two statements were 83% "accepted completely" and 17% "accepted with some reservation." Of particular significance, automated flexible endoscope reprocessors were mandated for high-level disinfection, and the use of forced-air drying cabinets was mandated for endoscope storage. These evidence-based statements encourage preventative strategies with the aim of ensuring the highest possible standards in flexible endoscope reprocessing thereby optimizing patient safety. They must be considered in addition to the broader published guidelines on infection control in endoscopy.

Enteroendocrine and adipokine associations with type 2 diabetes: Phenotypic risk scoring approaches.

BACKGROUND AND AIM: The contribution of gut-derived factors to the mechanisms linking obesity and metabolic disease remains under-investigated. The aim of the current study was to examine the associations between glucagon and enteroendocrine signaling and type 2 diabetes (T2D) using a derived risk score approach. To compare the relative importance of the enteroendocrine system, associations between adipokine measures and T2D were also investigated. METHODS: A total of 130 individuals with T2D and 161 individuals without T2D were included in the study. Circulating concentrations of enteroendocrine (glucagon, ghrelin, glucagon-like peptide-1, and gastric inhibitory peptide) and adipokine mediators (adiponectin, leptin, resistin, visfatin, and adipsin) were measured. Standard scores (Z-scores) were determined for each measure and enteroendocrine risk scores (ERS) and adipokine risk scores (ARS) calculated based on summation of the component measures. Associations between both the ERS and ARS and T2D status were assessed using logistic regression models. RESULTS: The ERS was significantly associated with T2D status in an adjusted model (odds ratio: 1.36; 95% confidence interval [CI]: 1.08-1.72; P = 0.009). Associations between the ARS and T2D status were not independent of age, sex, and body mass index (odds ratio: 1.21; 95%CI: 0.99-1.47; P = 0.06). Quantification of risk across ERS tertiles revealed that individuals with an ERS in the upper tertile were 10 times more likely (CI: 3.23-32.73; P < 0.001) to have T2D. CONCLUSIONS: These data support an association between enteroendocrine signaling and T2D. Use of the ERS as a potential tool for classifying individuals with metabolic syndrome as high or low risk for T2D development is being considered.

Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma.

Hilar cholangiocarcinoma (HCCA) is one of the most common types of hepatobiliary cancers reported in the world including Asia-Pacific region. Early HCCA may be completely asymptomatic. When significant hilar obstruction develops, the patient presents with jaundice, pale stools, dark urine, pruritus, abdominal pain, and sometimes fever. Because no single test can establish the definite diagnosis then, a combination of many investigations such as tumor markers, tissue acquisition, computed tomography scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography, endoscopic ultrasonography/intraductal ultrasonography, and advanced cholangioscopy is required. Surgery is the only curative treatment. Unfortunately, the majority of HCCA has a poor prognosis due to their advanced stage on presentation. Although there is no survival advantage, inoperable HCCA managed by palliative drainage may benefit from symptomatic improvement. Currently, there are three techniques of biliary drainage which include endoscopic, percutaneous, and surgical approaches. For nonsurgical approaches, stent is the most preferred device and there are two types of stents i.e. plastic and metal. Type of stent and number of stent for HCCA biliary drainage are subjected to debate because the decision is made under many grounds i.e. volume of liver drainage, life expectancy, expertise of the facility, etc. Recently, radio-frequency ablation and photodynamic therapy are promising techniques that may extend drainage patency. Through a review in the literature and regional data, the Asia-Pacific Working Group for hepatobiliary cancers has developed statements to assist clinicians in diagnosing and managing of HCCA. After voting anonymously using modified Delphi method, all final statements were determined for the level of evidence quality and strength of recommendation.

Comparison of endoscopic ultrasound and computed tomography for the preoperative evaluation of pancreatic cancer: a systematic review.

BACKGROUND & AIMS: It is uncertain whether computed tomography (CT) or endoscopic ultrasound (EUS) is superior for the detection, staging, and resectability of pancreatic cancer. We therefore performed a systematic literature review to determine which test is more accurate. METHODS: We identified relevant studies from MEDLINE (1986-2004) and evaluated study quality, which was measured on the basis of guidelines for assessing studies of diagnostic tests. Quantitative outcomes data were abstracted from the studies. RESULTS: Eleven studies with 678 patients satisfied inclusion criteria. Nine studies assessed tumor detection, all of which concluded that the sensitivity of EUS was superior to CT. Four of 5 studies that assessed tumor staging accuracy and 5 of 8 that assessed nodal staging accuracy concluded that EUS was superior to CT. Among the 4 studies that assessed resectability, 2 showed no difference between EUS and CT, and 1 favored each modality. Three of 11 studies met all but one of the quality criteria. The most important and frequent study limitations were lack of a consecutive series of patients and biased patient selection for surgery. Quantitative comparisons among studies were precluded by differences in tumor staging classifications, surgical selection, CT and EUS techniques, and reporting of operating characteristics. CONCLUSIONS: The published literature comparing EUS and CT for preoperative assessment of pancreatic cancer is heterogeneous in study design, quality, and results. All studies have methodologic limitations that potentially affect validity. Prospective studies with state-of-the-art imaging are needed to further define the role of each test.

Endoscopic ultrasound in non-small cell lung cancer and negative mediastinum on computed tomography.

Despite technical advances in staging non-small cell lung cancer (NSCLC), accurate staging remains a challenge. Endoscopic ultrasound is useful in staging NSCLC when lymphadenopathy is present on a computed tomography (CT), but its role in the absence of lymphadenopathy on CT has not been well defined. Therefore, we sought to determine the clinical impact of endoscopic ultrasound (EUS) in staging NSCLC in absence of mediastinal lymphadenopathy on CT. Seventy-six patients with NSCLC with absence of mediastinal lymphadenopathy on CT were enrolled and followed prospectively. EUS-guided fine-needle aspiration was performed on sites that were suspicious for metastases. Surgical pathology after thoracotomy was used as the reference standard for assessing accuracy. Sixty-two (86%) patients underwent surgery, and 10 (13%) did not. EUS precluded surgery in 9 patients (12%) and influenced management in 18 (25%) of all patients in this study. EUS detected malignant mediastinal lymphadenopathy more frequently in patients with lower lobe and hilar cancers combined compared with upper lobe cancers (p = 0.004). EUS played a significant role in identifying patients with unresectable (N3) NSCLC when adenopathy was not present on CT imaging and appears to be more sensitive in detecting lymph node metastases in lower lobe and hilar NSCLC compared with upper lobe NSCLC.

Comparison of endoscopic ultrasonography and multidetector computed tomography for detecting and staging pancreatic cancer.

BACKGROUND: Accurate preoperative detection and staging of pancreatic cancer may identify patients with locoregional disease that is amenable to surgical resection. OBJECTIVE: To compare endoscopic ultrasonography and multidetector computed tomography (CT) for the detection, staging, and resectability of known or suspected locoregional pancreatic cancer. DESIGN: Prospective, observational, cohort study. SETTING: Single, tertiary referral hospital in Indianapolis, Indiana. PATIENTS: 120 participants with known or suspected locoregional pancreatic cancer. INTERVENTIONS: Endoscopic ultrasonography followed by multidetector CT was performed in all patients. Patients with known or suspected pancreatic cancer deemed potentially resectable by 1 or both tests were considered for surgery. MEASUREMENTS: Detection, staging, and resectability of pancreatic cancer. Surgically resected pancreatic cancer with negative microscopic histologic margins was considered resectable. RESULTS: Of 120 patients enrolled, 104 (87%) underwent endoscopic ultrasonography and CT. Of the 80 patients with pancreatic cancer, 27 (34%) were managed nonoperatively, and 53 (66%) treated surgically had resectable (n = 25) or unresectable (n = 28) cancer. For the 80 patients with cancer, the sensitivity of endoscopic ultrasonography (98% [95% CI, 91% to 100%]) for detecting a pancreatic mass was greater than that of CT (86% [CI, 77% to 93%]; P = 0.012). For the 53 surgical patients, endoscopic ultrasonography was superior to CT for tumor staging accuracy (67% vs. 41%; P < 0.001) but equivalent for nodal staging accuracy (44% vs. 47%; P > 0.2). Of the 25 resectable pancreatic tumors in patients recommended for surgery, endoscopic ultrasonography and CT correctly identified 88% and 92%, respectively, as resectable. Of the 28 unresectable pancreatic tumors in patients recommended for surgery, endoscopic ultrasonography and CT correctly identified 68% and 64%, respectively, as unresectable. LIMITATIONS: Radiologists who read the scans and endosonographers were not blinded to previous radiographic information. Because of the modest sample size, CIs of the sensitivity estimates were sometimes wide. CONCLUSION: Compared with multidetector CT, endoscopic ultrasonography is superior for tumor detection and staging but similar for nodal staging and resectability of preoperatively suspected nonmetastatic pancreatic cancer.

Clinical utility of stent cytology for the diagnosis of pancreaticobiliary neoplasms.

OBJECTIVE: ERCP is frequently the technique of choice for the diagnosis and palliative treatment of pancreaticobiliary neoplasms. The sensitivity of tissue sampling techniques has been disappointing. Two small series have reported a high diagnostic yield from cytological examination of cellular debris from removed biliary stents. The aim of this study was to determine the clinical utility of stent cytology for the diagnosis of biliary and pancreatic neoplasia. METHODS: Patients who had biliary or pancreatic stents removed at ERCP and evaluated cytologically were the subjects of this study. Stents were scraped and washed, and the cellular debris was examined cytologically and recorded as positive, atypical, or negative. Patient demographics, ductal stricture, and stent characteristics were recorded. RESULTS: Between January, 1994 and January, 2001 a total of 126 biliary stents from 101 patients (61 male, 40 female, mean age 62 yr) and 29 pancreatic stents from 19 patients (seven male, 12 female, mean age 58 yr) were examined. The sensitivity, specificity, positive predictive value, and negative predictive value of biliary and pancreatic stents for the diagnosis of neoplasia were: 11%, 100%, 100%, 53%, and 25%, 100%, 100%, 77.8%, respectively. The sensitivity improved slightly if all degrees of atypia were considered positive for neoplasia. The mean duration of stent placement was 93.6 days for biliary stents and 43.5 days for pancreatic stents. CONCLUSIONS: Biliary and pancreatic stent cytology has limited clinical utility in the diagnosis of pancreaticobiliary neoplasia, owing to poor sensitivity. In addition, the time lag between stent placement and removal for cytologic examination further limits its contribution to patient management.

A new synthetic porcine secretin for facilitation of cannulation of the dorsal pancreatic duct at ERCP in patients with pancreas divisum: a multicenter, randomized, double-blind comparative study.

BACKGROUND: Secretin, a 27 amino acid polypeptide released in response to duodenal luminal acidification, stimulates secretion of water and bicarbonate from pancreatic ductal cells. To date the only secretin available for clinical use has been a biologically derived compound extracted from porcine duodenums. Although used to facilitate pancreatic duct cannulation, secretin has not been approved for this indication. In this study, a new synthetic porcine secretin with an identical amino acid composition was compared with saline solution for the facilitation of minor papilla cannulation in patients with pancreas divisum. METHODS: A multicenter, prospective, randomized, placebo-controlled, double-blind, comparative trial was conducted at 4 centers with expertise in pancreaticobiliary endoscopy. Patients with pancreas divisum in whom minor papilla cannulation initially was unsuccessful were enrolled. Either saline solution (placebo) or synthetic porcine secretin was administered. If the minor papilla orifice and/or pancreatic juice flow was noted, cannulation was attempted and success or failure was documented (phase 1), as well as the time taken for successful cannulation. If cannulation was unsuccessful, no juice flow was noted, or the orifice was not seen, the alternate agent was administered (phase 2). RESULTS: Twenty-nine patients (7 men, 22 women; mean age 51 years, range 21-76 years) were enrolled. In phase 1, cannulation was achieved in 1 of 13 patients (7.7%) after the placebo was given and in 13 of 16 patients (81.3%) after synthetic porcine secretin was given (p < 0.0001). In phase 2, cannulation was achieved in 12 of 12 patients (100%) after synthetic porcine secretin was given and in 0 of 3 patients (0%) after the placebo was given (p = 0.0022). Overall, cannulation was successful in 25 of 28 patients (89.3%) who received synthetic porcine secretin and in 1 of 16 (6.3%) who received the placebo (p < 0.0001). Mean time to cannulation was significantly greater for the placebo than for the synthetic porcine secretin (4.75 min vs. 2.63 min; p = 0.0001). No adverse events directly attributable to synthetic porcine secretin administration were documented. CONCLUSIONS: This study confirmed the use and safety of synthetic porcine secretin in facilitating cannulation of the minor papilla in patients with pancreas divisum in whom cannulation was difficult. Use of this agent has the potential to further increase the cannulation success rate in this group of patients.

Facilitation of pancreatic duct cannulation using a new synthetic porcine secretin.

OBJECTIVES: Cannulation of the pancreatic duct at ERCP can represent a technical challenge, even to experienced pancreaticobiliary endoscopists. Secretin is a polypeptide hormone that increases the volume and bicarbonate content of pancreatic secretions. We report our single center experience in the use of a new synthetic porcine secretin (sPS) for the facilitation of cannulation of either the major or minor pancreatic orifice during ERCP. METHODS: Patients presenting for a variety of indications were enrolled. If identification or cannulation of the desired pancreatic duct was difficult, 0.2 microg/kg of sPS was administered i.v. Cannulation success or failure was recorded. RESULTS: Between March, 1999, and May, 2000, a total of 25 patients (seven men and 18 women) were enrolled. The most frequent indication (15 of 25 cases) was facilitation of dorsal pancreatic duct cannulation in patients with pancreas divisum. The overall rate of successful cannulation secretin administration was 24 of 25 cases (96%). No adverse events directly attributable to secretin were observed. CONCLUSIONS: The results of this study show that sPS is safe and efficacious in faciliting cannulation of either the major or minor pancreatic orifice at ERCP in the subset of patients who represent cannulation difficulties. Once commercially available, sPS can be added to the armamentarium of techniques to facilitate ERP.

Clinical utility of EUS-guided fine-needle aspiration of mediastinal masses in the absence of known pulmonary malignancy.

BACKGROUND: Mediastinal masses represent a diagnostic challenge because of their proximity to numerous critical structures, difficulty of access for tissue sampling, and myriad potential pathologic etiologies. A large, single-center experience with EUS-guided fine-needle aspiration (EUS-FNA) in the diagnosis of non-lung cancer-related mediastinal masses is presented. METHODS: An EUS database was reviewed and all cases of mediastinal mass or lymphadenopathy encountered between 1994 and 1999 were included. Final diagnoses were determined by EUS-FNA cytology and clinical follow-up. RESULTS: Forty-nine patients were identified (27 women, 22 men; mean age 58.1 years, range 30-89 years). A malignant process was diagnosed in 22 cases (45%) and a benign process in 24 (49%). The EUS-FNA specimen was nondiagnostic in 3 cases (6%). An accurate diagnosis was made in 46 of the 49 patients (94%). No complication was noted. CONCLUSIONS: EUS-FNA is a minimally invasive technique that facilitates detection and tissue sampling of mediastinal masses. It is a safe procedure that can be performed with the patient under conscious sedation in an outpatient setting.