Topical pharyngeal anesthesia with articaine for gastroscopy: a double-blinded, randomized cross-over study in healthy volunteers.

OBJECTIVES: The benefits of topical pharyngeal anesthesia for gastroscopy remain under debate. Articaine, a local anesthetic with fast onset and offset of action as well as low systemic toxicity, could be a promising choice for topical anesthesia. The objective of this study was to assess whether topical pharyngeal anesthesia with articaine is beneficial in sedated gastroscopy. MATERIALS AND METHODS: This randomized double-blinded cross-over study included nine volunteers who underwent two gastroscopies under conscious sedation. One was performed with topical pharyngeal anesthesia with articaine and the other with placebo. Hemodynamic parameters including autonomic nervous system state were recorded prior to and during the endoscopic procedure. The endoscopist and the volunteer assessed the endoscopy after the examination. RESULTS: Topical pharyngeal anesthesia with articaine resulted in less discomfort during esophageal intubation and higher patient satisfaction with the procedure. Topical pharyngeal anesthesia with articaine did not increase satisfaction or facilitate the procedure as rated by the endoscopist. There were no clinically relevant differences in hemodynamic parameters. CONCLUSION: The use of articaine for topical pharyngeal anesthesia results in less intubation-related discomfort and better satisfaction.

Endoscopic therapy of sporadic non-ampullary duodenal adenomas, single centre retrospective analysis.

INTRODUCTION: Although sporadic non-ampullary duodenal adenomas (SNADA) are rare, with the risk of progression to cancer, they deserve therapy. Endoscopic therapy of SNADA is effective, but with the increased risk of complications, endotherapy should be performed in high-volume units. The results of endotherapy of SNADA in our unit are presented. PATIENTS AND METHODS: A total of 97 patients with SNADA had endoscopic resection in 2005-2021 and control endoscopies between 3 and 24 months. Snare polypectomy, endoscopic mucosal resection (EMR), endoscopic band ligation (EBL) and endoloop were used (en bloc 37% and piecemeal 63%). In cases of residual/recurrent adenomas, endotherapy was repeated. RESULTS: The median size of the adenoma was 12 (5-60) mm and most polyps were sessile (25%) or flat (65%). Primary endotherapy eradicated adenomas in 57 (59%) cases. Residual and recurrence rates were 24% (n = 23) and 17% (n = 16) with successful endotherapy in 16 (70%) and 13 (81%) patients. Endotherapy was successful in 86 (89%) patients after a median (range) follow-up of 23 (1-166) months. Four out of 11 patients with failed endotherapy had surgery; seven patients were not fit for surgery. There were no disease-specific deaths or carcinoma. Eleven patients (11%) suffered from complications: perforation requiring surgery (n = 1), sepsis (n = 1), postprocedure bleeding (n = 7), cardiac arrest (n = 1) and coronary infarct (n = 1). The thirty-day mortality was zero. Colonoscopy was performed on 67 (69%) patients with neoplastic lesions in 33% patients during follow-up. CONCLUSIONS: Endotherapy of SNADA is effective and safe. Repeat endotherapy in residual and recurrent adenomas is successful. Careful patient selection is mandatory. Abbreviations: ASA: American Society of Anesthesiologist classification; BMI: body mass index; CT: computed tomography; EBL: endoscopic band ligation; EMR: endoscopic mucosal resection; ESD: endoscopic submucosal dissection; ET: endotherapy; FAP: familial adenomatous polyposis; F: female; LST: laterally spreading tumours; M: male; SD: standard deviation; SNADA: sporadic nonampullary duodenal adenoma.

Single-operator peroral pancreatoscopy in the preoperative diagnostics of suspected main duct intraductal papillary mucinous neoplasms: efficacy and novel insights on complications.

BACKGROUND: Distinguishing intraductal papillary mucinous neoplasms (IPMNs) from other pancreatic cystic lesions is essential since IPMNs carry the risk of becoming malignant. Differentiating the main pancreatic duct involving IPMNs (MD-IPMNs) through conventional imaging is deficient. Single-operator peroral pancreatoscopy (SOPP) represents a promising method offering additional information on suspected lesions in the pancreatic main duct (MD). We aimed to determine the role of SOPP in the preoperative diagnostics of suspected MD-IPMNs and identify factors contributing to SOPP-related complications. MATERIALS AND METHODS: In this primarily retrospective study, SOPPs were performed at three high-volume centers on suspected MD-IPMNs. Primary outcome was the clinical impact of SOPP to subsequent patient care. Additionally, we documented post-SOPP complications and analyzed several assumed patient- and procedure-related risk factors. RESULTS: One hundred and one (101) SOPPs were performed. Subsequent clinical management was affected due to the findings in 86 (85%) cases. Surgery was planned for 29 (29%) patients. A condition other than IPMN explaining MD dilatation was found in 28 (28%) cases. In 35 (35%) cases, follow-up with MRI was continued. Post-SOPP pancreatitis occurred in 20 (20%) patients and one of them was fatal. A decrease in odds of post-SOPP pancreatitis was seen as the MD diameter increases (OR 0.714 for 1.0 mm increase in MD diameter, CI 95% 0.514-0.993, p = 0.045). Furthermore, a correlation between lower MD diameter values and higher severity post-SOPP pancreatitis was seen (TJT = 599, SE = 116.6, z = - 2.31; p = 0.020). History of pancreatitis after endoscopic retrograde cholangiopancreatography was a confirmed risk factor for post-SOPP pancreatitis. Conclusions between complications and other risk factors could not be drawn. CONCLUSION: SOPP aids clinical decision-making in suspected MD-IPMNs. Risk for post-SOPP pancreatitis is not negligible compared to non-invasive imaging methods. The risk for pancreatitis decreases as the diameter of the MD increases.

Transpancreatic biliary sphincterotomy versus double guidewire in difficult biliary cannulation: a randomized controlled trial.

BACKGROUND: Difficult biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) increases the risk of post-ERCP pancreatitis (PEP). The purpose of this prospective, randomized, multicenter study was to compare two advanced rescue methods, transpancreatic biliary sphincterotomy (TPBS) and a double-guidewire (DGW) technique, in difficult common bile duct (CBD) cannulation. METHODS: Patients with native papilla and planned CBD cannulation were recruited at eight Scandinavian hospitals. An experienced endoscopist attempted CBD cannulation with wire-guided cannulation. If the procedure fulfilled the definition of difficult cannulation and a guidewire entered the pancreatic duct, randomization to either TPBS or to DGW was performed. If the randomized method failed, any method available was performed. The primary end point was the frequency of PEP and the secondary end points included successful cannulation with the randomized method. RESULTS: In total, 1190 patients were recruited and 203 (17.1 %) were randomized according to the study protocol (TPBS 104 and DGW 99). PEP developed in 14/104 patients (13.5 %) in the TPBS group and 16/99 patients (16.2 %) in the DGW group (P = 0.69). No difference existed in PEP severity between the groups. The rate of successful deep biliary cannulation was significantly higher with TPBS (84.6 % [88/104]) than with DGW (69.7 % [69/99]; P = 0.01). CONCLUSIONS: In difficult biliary cannulation, there was no difference in PEP rate between TPBS and DGW techniques. TPBS is a good alternative in cases of difficult cannulation when the guidewire is in the pancreatic duct.

Repeated Negative Urine Trypsinogen-2 Dipstick Test Rules Out Diagnosis of Post-ERCP Pancreatitis.

BACKGROUND: A dipstick test for urine trypsinogen-2 has been used in the diagnosis of acute pancreatitis, but there are only a few studies exploring the effectiveness of this test for early diagnose of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). GOALS: The authors explore if the rapid point-of-care urine trypsinogen-2 dipstick test can replace assay of amylase in diagnosing PEP. STUDY: For this prospective study, from Helsinki University Hospital 400 ERCP patients were enrolled in whom the authors analyzed plasma amylase or pancreas-specific amylase, bilirubin, and urine trypsinogen-2, and urine trypsinogen-2 with dipstick before, 4 and 24 hours after ERCP. RESULTS: PEP developed in 15 (3.8%) patients. Urine trypsinogen-2 concentrations were significantly higher in PEP than in non-PEP patients 24 hours after ERCP (P=0.001, Mann-Whitney U test) but not 4 hours after ERCP (P=0.094). When combined with abdominal pain symptoms at 4 hours the dipstick test had a sensitivity of 60%, a specificity of 99%, a positive predictive value of 64%, and a negative predictive value 98%. At 24 hours, sensitivity was 100%, specificity 98%, positive predictive value 71%, and negative predictive value 100%. CONCLUSIONS: A positive dipstick seems to identify PEP cases and a negative test excludes PEP with high accuracy.

Transpancreatic biliary sphincterotomy for biliary access is safe also on a long-term scale.

BACKGROUND: Transpancreatic biliary sphincterotomy (TPBS) is an advanced cannulation method for accessing common bile duct (CBD) in endoscopic retrograde cholangiopancreatography (ERCP). If CBD cannulation is difficult, an endoscopist can open the septum between the pancreatic and biliary duct with a sphincterotome to gain access. Long-term results of this procedure are unclear. We wanted to evaluate the short- and long-term complications of TPBS on patients with native papilla and benign indication for ERCP. PATIENTS AND METHODS: ERCPs performed in Helsinki University Hospital between 2007 and 2013 were reviewed. The study group comprised 143 consecutive patients with TPBS and 140 controls (CG). Data were collected from patient records and a phone survey was performed as a follow-up ≥ 4 years after the index ERCP. RESULTS: Post-ERCP pancreatitis (PEP) developed in seven patients (4.9%) in TPBS and one patient (0.7%) in CG (p = 0.067). The rates of other acute complications were similar between the groups. ERCP ended with no access to CBD in four cases (2.8%) in TPBS. The median length of follow-up was 6 years in TPBS and 7 years in CG. During this period, three patients (2.1%) in TPBS and six patients (4.3%) in CG suffered from acute pancreatitis (AP) (p = 0.238). One (0.7%) patient in CG and none in TPBS developed chronic pancreatitis (CP). Abdominal pain was suffered by ten patients (6.9%) in TPBS and twelve patients (8.6%) in CG daily, whereas by six patients (4.2%) in TPBS and twelve patients (8.6%) in CG weekly. CONCLUSION: TPBS is a useful procedure, with acceptable complication rates. No significant difference occurred between the groups when evaluating the short-term or long-term complications with a follow-up period of four to 10 years. Additionally, no significant differences occurred in upper abdominal pain, episodes of AP, or development of CP.

Benign biliary strictures treated with biodegradable stents in patients with surgically altered anatomy using double balloon enteroscopy.

OBJECTIVES: Surgically altered anatomy complicates endoscopical procedures of pancreatobiliary tree. Biliary or hepaticojejunal anastomosis strictures have been managed using percutaneous transhepatic or double balloon enteroscopy (DBE) techniques with multiple plastic stents, or fully covered self-expandable metal stents. We report the first seven cases with surgically altered anatomy treated with biodegradable stents with DBE. MATERIALS AND METHODS: Seven cases with altered anatomy, all with Roux-en-Y hepaticojejunostomy (HJ), were treated for HJ anastomosis strictures (3 cases) and intrahepatic biliary stricture (4 cases). Fujifilm DB enteroscope with a 200 cm long and 3.2 mm wide working channel was used. Balloon dilatations were first performed and then 1-3 biodegradable stents were deployed with a pusher over a guidewire. RESULTS: Two patients had HJ due to liver resections, one due to biliary injury in cholecystectomy and four due to liver transplantation because of primary sclerosing cholangitis (PSC). Median duration of the procedures was 56 min. Deployment of the stents took less than 20 min per patient. There were no stent or cholangiography related adverse events, but one patient required endotracheal intubation for nose bleeding caused by the placement of nasopharyngeal tube. Two PSC patients had recurrent cholangitis in the follow up. There was one stent migration in 90 day follow up. With all the HJ anastomotic strictures resolution of strictures seemed to be achieved. CONCLUSIONS: Treatment of biliary or anastomosis strictures in altered anatomy is complex and time consuming. The biodegradable stent, which can be passed through working channel of a long enteroscope, seems promising in the treatment of these strictures. The benefit is that no stent removal is needed.

Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. METHODS: This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2 < 90%). Mann-Whitney test for continuous variables and Fisher's exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups. RESULTS: There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters. CONCLUSIONS: Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.

Macroscopic appearance of the major duodenal papilla influences bile duct cannulation: a prospective multicenter study by the Scandinavian Association for Digestive Endoscopy Study Group for ERCP.

BACKGROUND AND AIMS: Certain appearances of the major duodenal papilla have been claimed to make cannulation more difficult during ERCP. This study uses a validated classification of the endoscopic appearance of the major duodenal papilla to determine if certain types of papilla predispose to difficult cannulation. METHODS: Patients with a naïve papilla scheduled for ERCP were included. The papilla was classified into 1 of 4 papilla types before cannulation started. Time to successful bile duct cannulation, attempts, and number of pancreatic duct passages were recorded. Difficult cannulation was defined as after 5 minutes, 5 attempts, or 2 pancreatic guidewire passages. RESULTS: A total of 1401 patients were included from 9 different centers in the Nordic countries. The overall frequency of difficult cannulation was 42% (95% confidence interval [CI], 39%-44%). Type 2 small papilla (52%; 95% CI, 45%-59%) and type 3 protruding or pendulous papilla (48%; 95% CI, 42%-53%) were more frequently difficult to cannulate compared with type 1 regular papilla (36%; 95% CI, 33%-40%; both P < .001). If an inexperienced endoscopist started cannulation, the frequency of failed cannulation increased from 1.9% to 6.3% (P < .0001), even though they were replaced by a senior endoscopist after 5 minutes. CONCLUSIONS: The endoscopic appearance of the major duodenal papilla influences bile duct cannulation. Small type 2 and protruding or pendulous type 3 papillae are more frequently difficult to cannulate. In addition, cannulation might even fail more frequently if a beginner starts cannulation. These findings should be taken into consideration when performing studies regarding bile duct cannulation and in training future generations of endoscopists.

Fully covered self-expanding metal stents for benign refractory pancreatic duct strictures in chronic pancreatitis.

Background: Pancreatic duct (PD) stricture is a common adverse event in chronic pancreatitis (CP). Primary treatment for refractory PD strictures is endotherapy (ET), including the insertion of multiple plastic stents. In addition, fully covered self-expandable metal stents (FC-SEMSs) have also been successfully used. More long-term studies are necessary to clarify the complication rate and efficiency, however. Methods: This retrospective study was comprised of 17 patients with symptomatic CP and refractory fibrotic main pancreatic duct (MPD) stricture treated with FC-SEMSs between 2010-2018 at the Helsinki University Hospital. Treated strictures were located in the pancreatic head. Technical success was defined as the accurate positioning of the stent and resolution of the MPD stricture. Clinical success was defined as pain relief at the end of the follow-up. Results: In 12 patients (71%), stricture resolution was accomplished. Clinical success was achieved in 12 patients (71%). The median duration of stenting was 169 days (range 15-804). Ten patients (58.8%) underwent a follow-up of two years or more. Early complications (≤7 days) occurred in two patients (12%): one pancreatitis and one cholestasis. Late complications (≥7 days) included severe abdominal pain (n = 2, 12%), pancreatitis (n = 3, 18%), cholestasis (n = 1, 6%) and stent migration (n = 7, 35%). Significant differences in stricture resolution and pain improvement were evident in patients with stent migration compared to patients without stent migration [1(14.3%) vs. 11(84.6%), p = .004 and 2(28.6%) vs. 11(84.6%), p = .022]. Conclusion: FC-SEMS placement is a safe and potentially effective treatment for this challenging group of patients. However, stent migration appears to affect the clinical and technical outcome.

Assessment of sedation level for endoscopic retrograde cholangiopancreatography - a prospective validation study.

BACKGROUND AND AIMS: There is no consensus on how to assess the depth of sedation for endoscopic retrograde cholangiopancreatography (ERCP). This study was carried out in order to evaluate different methods of assessment of depth of sedation: bispectral index (BiS), modified Richmond Agitation/Sedation Scale (mRASS), modified Ramsay Sedation Scale (mRSS) and modified Observer Assessment of Alertness and Sedation (mOAAS) and their applicability to clinical practice. METHODS: Two hundred patients were recruited. Sedation was given by standard clinical practice using propofol sedation or patient controlled sedation. Sedation was assessed on all patients using the above-mentioned methods. BiS was considered the reference point for sedation scales. Cronbach's alpha was calculated to determine the consistency of different scales in respect to each other and prediction probability and Spearman's correlation coefficients of sedation scales were calculated to show the relationship between sedation scales and BiS. RESULTS: All scales showed high reliability with overall Cronbach's alpha 0.943. Dropping scales suggested better consistency between mOAAS, mRSS and mRASS than with BiS. Spearman's correlation and prediction probability showed similar results with all tested scales: mOAAS (0.695, 0.739), mRSS (0.673, 0.735), mRASS (0.683, 0.738), p < .01 for all scales. CONCLUSIONS: All tested methods were found to be reliable in the assessment of the depth of sedation when compared with each other. However, mRASS, mRSS and mOAAS require the patient to respond to verbal or tactile stimulus, which may impair execution of ERCP, whereas BiS information is collected directly from electroencephalogram and thus may be preferable in clinical setting.

An immunocapture-LC-MS-based assay for serum SPINK1 allows simultaneous quantification and detection of SPINK1 variants.

Pancreatic secretory trypsin inhibitor Kazal type 1 (SPINK1) is a 6420 Da peptide produced by the pancreas, but also by several other tissues and many tumors. Some mutations of the SPINK1 gene, like the one causing amino acid change N34S, have been shown to confer susceptibility to recurrent or chronic pancreatitis. Detection of such variants are therefore of clinical utility. So far SPINK1 variants have been determined by DNA techniques. We have developed and validated an immunocapture-liquid chromatography-mass spectrometric (IC-LC-MS) assay for the detection and quantification of serum SPINK1, N34S-SPINK1, and P55S-SPINK1. We compared this method with a time-resolved immunofluorometric assay (TR-IFMA) for serum samples and primer extension analysis of DNA samples. We used serum and DNA samples from patients with acute pancreatitis, renal cell carcinoma, or benign urological conditions. With the help of a zygosity score calculated from the respective peak areas using the formula wild-type (wt) SPINK1/(variant SPINK1 + wt SPINK1), we were able to correctly characterize the heterozygotes and homozygotes from the samples with DNA information. The score was then used to characterize the apparent zygosity of the samples with no DNA characterization. The IC-LC-MS method for SPINK1 was linear over the concentration range 0.5-1000 µg/L. The limit of quantitation (LOQ) was 0.5 µg/L. The IC-LC-MS and the TR-IFMA assays showed good correlation. The median zygosity score was 1.00 (95% CI 0.98-1.01, n = 11), 0.55 (95% CI 0.43-0.61, n = 14), and 0.05 (range 0.04-0.07, n = 3) for individuals found to be wt, heterozygous, and homozygous, respectively, for the N34S-SPINK1 variant by DNA analysis. When DNA samples are not available, this assay facilitates identification of the N34S- and P55S-SPINK1 variants also in archival serum samples.

Endoscopic Therapy of Biliary Injury After Cholecystectomy.

BACKGROUND: Iatrogenic bile duct injury (BDI) is a common complication after cholecystectomy. Patients are mainly treated endoscopically, but the optimal treatment method has remained unclear. AIMS: The aim was to analyze endoscopic treatment in BDI after cholecystectomy and to explore endoscopic sphincterotomy (ES), with or without stenting, as the primary treatment for an Amsterdam type A bile leak. METHODS: All patients referred to Helsinki University Hospital endoscopy unit due to a suspected BDI between the years 2004 and 2014 were included in this retrospective study. To collect the data, all ERC reports were reviewed. RESULTS: Of the 99 BDI patients, 94 (95%) had bile leak of whom 11 had concomitant stricture. Ninety-three percent of all patients were treated endoscopically. Seventy-one patients had native papillae and a leak in the cystic duct or peripheral radicals. They were treated with ES (ES group, n = 50) or with sphincterotomy and stenting (EST group, n = 21). There was no difference between the closure time of the fistula (p = 0.179), in the time of discharge from hospital (p = 0.298), or in the primary healing rate between the ES group and the EST group (45/50 vs 19/21 patients, p = 0.951). CONCLUSION: After the right patient selection, the success rate of endoscopic treatment can approach 100% for Amsterdam type A bile leak. ES is an effective and cost-effective single procedure with success rate similar to EST. It may be considered as a first-line therapy for the management of Amsterdam type A leaks.

How patient-controlled sedation is adopted in clinical practice of sedation for endoscopic retrograde cholangiopancreatography? A prospective study of 1196 cases.

OBJECTIVE: Patient-controlled sedation (PCS) has been shown to be a valid choice for sedation during endoscopic retrograde cholangiopancreatography (ERCP) in randomized studies. However, large-scale studies are lacking. MATERIAL AND METHODS: A single center, prospective observational study to determine how sedation for ERCP is administered in clinical setting. All 956 patients undergoing 1196 ERCPs in the endoscopy unit of Helsinki University Central Hospital 2012-2013, methods of sedation and adverse events associated with different sedations were recorded. RESULTS: PCS was attempted a total of 685 times (57%), successful use of PCS was achieved with 526 patients (77% of attempts). PCS device was operated by the anesthesiologist or anesthesia nurse 268 times (22%). PCS was more likely chosen for younger (80.6% for < =60 years vs. 63.8% for >60 years, p<.001) patients and by trainee anesthetists. Anesthesiologist administered propofol sedation was used 240 times (20%). The risk of failure of PCS was increased, if systolic arterial pressure was <90 mmHg, dosage of PCS >17 ml, duration of procedure exceeded 23 min. The risk of failure was lower in patients with primary sclerosing cholangitis (PSC) and if sedation was deeper RASS < =-2. Uneventful PCS was associated with less respiratory and cardiovascular depression than other methods. There were no statistically significant differences in safety profiles with all the methods of sedation. CONCLUSIONS: PCS is readily implemented in clinical practice, is suitable for younger and low-risk patients and is associated with less cardiorespiratory adverse effects.

A prospective randomised study of dense Infinity cytological brush versus regularly used brush in pancreaticobiliary malignancy.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) with a cytological sample is a valuable tool in the diagnosis of the aetiology of biliary stricture. Our aim was to evaluate whether a more dense Infinity® cytological brush is more sensitive in diagnosing malignancy than the regularly used brush. PATIENTS AND METHODS: We recruited 60 patients with a biliary stricture suspicious for malignancy for a randomised controlled trial. Patients were randomly assigned to an Infinity® brush group (n = 30) and a regularly used cytology brush group (n = 30). All the patients had verified cancer during follow-up. RESULTS: Crossing the brush over the stricture was possible in each case without dilatation of the biliary duct. Brush cytology yield was good or excellent in 86.7% of cases with the Infinity® brush and 96.7% with the regular brush (p = 0.161). The cytological sample showed clear malignancy in three patients (10.0%) in the Infinity® group and in 12 (40.0%) patients of the regular brush group (p = 0.007). The cytological diagnosis was highly suspicious for malignancy or malignant in 14 patients (46.7%) in the Infinity® group and in 23 patients (76.7%) in the regular brush group (p = 0.017). The result was benign in 10 patients (33.3%) in the Infinity® group and in four patients (13.6%) in the regular brush group (p = 0.067). CONCLUSIONS: With the standardised technique, the sensitivity of brush cytology is fairly good. The dense Infinity® brush does not show any advantage regarding sensitivity compared with the conventional cytology brush.

Long-term results of combined ESWL and ERCP treatment of chronic calcific pancreatitis.

OBJECTIVE: Extracorporeal shock wave lithotripsy (ESWL) combined with endotherapy (ET) is the standard treatment for pancreatic duct stones (PDS) in chronic pancreatitis (CP). Our aim was to report the short- and long-term results of ESWL and ET. MATERIAL AND METHODS: Consecutively treated 83 patients with symptomatic PDS using ESWL and ET. Success was defined (i) technically: PDS fragmentation and clearance obtained and (ii) clinically: improvement/resolution of pain. To get information on quality of life, we conducted a phone survey whereby we contacted 64 (89%) patients. The long-term results are presented in those patients with ≥2 years follow-up. RESULTS: Treated PDS with median size of 10 (5-25) mm were located in the head, body, or the tail of the pancreas in 78, 4, and 1 patients, respectively. The primary results were that technical success was achieved in 69 patients (83%) and clinical success in 66 patients (80%). Fourteen patients had technical failure, but eight of them became free of pain. Thus, clinical success can be considered to have been achieved in 74 of 83 patients (89%). In patients with persistent pseudocyst (PC) at the time of ESWL (n = 19), the PC disappeared in a year in 14 patients (74%). The long-term results were obtained from 61 (73%) ESWL- and ET-treated patients. The median follow-up for them was 53 months (range: 24-124) and 57 patients (93%) became pain-free or had less pain. CONCLUSIONS: For patients with CP and PDS ESWL combined with ET is an effective and safe treatment giving favorable long-term results.

Activated protein C retards recovery from coagulopathy in severe acute pancreatitis.

OBJECTIVES: Activated protein C (APC), an endogenous anticoagulant, has antithrombotic, fibrinolytic and anti-inflammatory properties. We recently conducted a controlled study (APCAP, activated protein C in severe acute pancreatitis) of APC treatment of patients with severe acute pancreatitis (SAP). Here we studied the effect of APC on the pivotal coagulation parameters of the surviving patients in the APCAP study. METHODS: The study consisted of 20 patients of whom 10 patients had received APC and 10 patients had received placebo. Coagulation parameters, physiological anticoagulants, thrombograms and circulating levels of IL-6 and CRP were determined on admission and at days 1, 3-4 and 6-7. RESULTS: During follow-up, the temporal levels of prothrombin time (PT) decreased and the temporal levels of thromboplastin time (TT) increased in placebo group (p< 0.001 for both), but not in APC group. The temporal levels of antithrombin (AT) increased less in APC group than in placebo group (p = 0.011). The shapes of the SAP patients' thrombograms were strongly deranged and were marginally affected by APC treatment. CONCLUSIONS: Coagulopathy in SAP, a complex phenomenon, is not alleviated by APC treatment. Rather, the patients receiving APC are heading toward normal homeostasis of coagulation slower than patients receiving placebo.

Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

BACKGROUND AND STUDY AIMS: The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. PATIENTS AND METHODS: This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. RESULTS: Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). CONCLUSION: A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747).

Assessment of indications for percutaneous endoscopic gastrostomy--development of a predictive model.

OBJECTIVE: Percutaneous endoscopic gastrostomy (PEG) is used for long-term enteral nutrition in neurological patients with dysphagia (NEUR), in head and neck cancer patients prior to chemoradiation therapy (head and neck malignancy group [HNM]), or in cases of oropharyngeal or esophageal tumor obstruction or stricture (OBSTR). Considerable morbidity and overall mortality is reported. Aim was to analyze the complication rates and mortality with PEG and to identify subgroups with poor outcomes. MATERIAL AND METHODS: Patients underwent PEG (n = 401) in a single tertiary care center. Indications, characteristics, and causes of death were recorded. RESULTS: Number of patients in groups: HNM 135 (34%), OBSTR 74 (18%), and NEUR 192 (48%); follow-up time median (interquartile range): 17 (39) months; the time PEG used for feeding: 4 (7) months. A total of 91 patients (23%) had 110 complications, 31 patients (8%) had early (≤30 days) complications, and 49 patients (12%) major complications. Two deaths (0.5%, 2 peritonitis) were related to PEG. The 30-day mortality was 11% (n = 47). According to multivariate analysis, an increased 30-day mortality was associated with ≥75 years of age, American Society of Anesthesiologists (ASA) class IV, a Charlson comorbidity index (CCI) ≥4, body mass index (BMI) <18.5, and ongoing antibiotic therapy. With this model, 95% specificity was obtained in the 30-day survival figures. CONCLUSION: The presented predictive model derived from our analysis may recognize patients with poor outcome when referred for PEG. The parameters in the present model (age, ASA class, CCI score, BMI, and data of ongoing antibiotic treatment) are easily measurable, and it is possible to integrate them into everyday work.

Syndecan-1 Levels and Early Positive Fluid Balance Are Associated With Disease Severity in Acute Pancreatitis.

OBJECTIVE: The aim of the study is to study fluid balance and endothelial glycocalyx degradation, reflected by syndecan-1, and heparan sulfate (HS) levels, in early stages of acute pancreatitis (AP). MATERIALS AND METHODS: This study comprised of 210 AP patients (104 mild, 53 moderately severe, 17 severe). Blood was sampled within 72 hours from the onset of symptoms, and plasma syndecan-1 and HS levels were determined using ELISA. Fluid balance up to sampling and up to 4 days was determined retrospectively from medical records. RESULTS: Syndecan-1 levels predicted severe AP (SAP) in receiver operating characteristic analysis [area under curve 0.699, 95% confidence interval (CI) 0.546 to 0.851, P = 0.021]. Increasing AP severity was associated with higher intravenous fluid intake and lower urine output. In multivariate binary logistic regression analysis, positive fluid balance up to sampling [odds ratio (OR) 1.05 per 100 ml, 95% CI 1.02 to 1.11, P = 0.010] and higher Acute Physiology and Chronic Health Evaluation II score at sampling (OR 1.48, 95% CI 1.20 to 1.83, P < 0.001) were independently associated with severe AP, while syndecan-1 level was not. CONCLUSIONS: SAP is associated with high positive fluid balance in the early stages of treatment. Although increased in SAP, syndecan-1 was not independently associated with SAP when controlling for fluid balance and Acute Physiology and Chronic Health Evaluation II score.