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Background: Bile duct injury (BDI) remains a daunting complication of laparoscopic cholecystectomy. In patients with complex BDI, a percutaneous-endoscopic rendezvous procedure may be required to establish bile duct continuity. The aim of this study was to assess short- and long-term outcomes of the rendezvous procedure.Methods: All consecutive patients with BDI referred to our tertiary referral center between 1995 and 2016 were analyzed. A rendezvous procedure was performed when endoscopic or radiologic intervention failed, and when deemed feasible by a dedicated multidisciplinary team including hepatopancreaticobiliary surgeons, gastrointestinal endoscopists, and interventional radiologists. Classification of BDI, technical success of the rendezvous procedure, procedure-related adverse events, and outcomes were assessed.Results: Among a total of 812 patients, rendezvous was performed in 47 (6 %), 31 (66 %) of whom were diagnosed with complete transection of the bile duct (Amsterdam type D/Strasberg type E injury). The primary success rate of rendezvous was 94 % (44 /47 patients). Overall morbidity was 18 % (10 /55 procedures). No life-threatening adverse events or 90-day mortality occurred. After a median follow-up of 40 months (interquartile range 23 - 54 months), rendezvous was the final successful treatment in 26 /47 patients (55 %). In 14 /47 patients (30 %), rendezvous acted as a bridge to surgery, with hepaticojejunostomy being chosen either primarily or secondarily to treat refractory or relapsing stenosis.Conclusions: In experienced hands, rendezvous was a safe procedure, with a long-term success rate of 55 %. When endoscopic or transhepatic interventions fail to restore bile duct continuity in patients with BDI, rendezvous should be considered, either as definitive treatment or as a bridge to elective surgery. [ABSTRACT FROM AUTHOR]

Background and study aims: Despite significant interest from health care authorities, patient organizations, and insurance companies, data on procedural outcome and quality of endoscopic retrograde cholangiopancreatography (ERCP) in general and academic practice are sparse. The aims of this study were to assess procedural outcome of ERCP within a large prospective registry in The Netherlands, and to evaluate associations between endoscopist-related factors and procedural outcome. Methods: All endoscopists performing ERCP in The Netherlands were invited to register their ERCPs over a 1-year period using the Rotterdam Assessment Form for ERCP (RAF-E). The primary outcome measure was procedural success. A priori difficulty level of the procedure was classified according to Schutz. Baseline characteristics of the endoscopist (e.g. previous experience) were recorded at study entry. Regression analysis was performed to identify predictors of procedural outcome. Results: A total of 8575 ERCPs were registered by 171 endoscopists from 61 centers, constituting about 50% of all ERCPs performed nationally during the study period. Overall procedural success was 85.8 %. Intact papillary anatomy was present in 5106 patients (59.5 %): procedural success in this subgroup of patients was 83.4% vs. 89.4% after sphincterotomy (P<0.001). Multivariate logistic regression identified "degree of difficulty," "intact papillary anatomy," and "previous ERCP failure" to be independently associated with procedural failure. "Yearly volume of ERCPs" and "trainee involvement" were independently associated with success. Conclusions: The nationwide prospective RAF-E registry proved to be a valuable tool to gain insight into procedural outcome of ERCPs. [ABSTRACT FROM AUTHOR]

Background and study aim: Measures for competence in endoscopic retrograde cholangiopancreatography (ERCP) during training are poorly defined. Currently, various training and accreditation programs base verification of competence on performance of a minimum number of procedures. There is a general awareness that procedural competence certification should be based on objective performance criteria. Continuous self-assessment using a Rotterdam Assessment Form for ERCP (RAF-E) can provide insight into trainee performance. The study aim was to express development in ERCP competence as a learning curve. Methods: ERCP trainees at a tertiary referral center in the Netherlandswere invited to participate. Performed procedures were appraised using RAF-E. Indication for each ERCP and presence of a virgin papillawere documented. Complexitywas graded on a 3-point scale. The primary outcome parameterwas common bile duct (CBD) cannulation success rate. Success of the intended therapeutic interventionswas additionally expressed as a learning curve. Results: 15 trainees were included. 1541 ERCPs (624 procedures in native papillary anatomy) were assessed through RAF-E. Unassisted CBD cannulation success rate improved from 36% at baseline to 85% after 200 procedures (P<0.001), and in 624 patients with a virgin papilla from 22% at baseline to 68% after 180 procedures (P< 0.001). Learning curves for therapeutic interventions showed significant improvements for successful sphincterotomy (P=0.01) and stent placement (P<0.001). Conclusions: Learning curves are a valuable means for assessing competence in ERCP. Differences in learning curves can be shown with RAF-E. Verification of competence should be based on actual performance, instead of minimum numbers. [ABSTRACT FROM AUTHOR]

Background: Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications than in non-jaundiced patients. Preoperative biliary drainage was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality. Early studies showed a reduction in morbidity. However, more recently the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. Whether biliary drainage should always be performed in jaundiced patients remains controversial. The randomized controlled multicenter DROP-trial (DRainage vs. Operation) was conceived to compare the outcome of a 'preoperative biliary drainage strategy' (standard strategy) with that of an 'early-surgery' strategy, with respect to the incidence of severe complications (primary-outcome measure), hospital stay, number of invasive diagnostic tests, costs, and quality of life. Methods/design: Patients with obstructive jaundice due to a periampullary tumor, eligible for exploration after staging with CT scan, and scheduled to undergo a "curative" resection, will be randomized to either "early surgical treatment" (within one week) or "preoperative biliary drainage" (for 4 weeks) and subsequent surgical treatment (standard treatment). Primary outcome measure is the percentage of severe complications up to 90 days after surgery. The sample size calculation is based on the equivalence design for the primary outcome measure. If equivalence is found, the comparison of the secondary outcomes will be essential in selecting the preferred strategy. Based on a 40% complication rate for early surgical treatment and 48% for preoperative drainage, equivalence is taken to be demonstrated if the percentage of severe complications with early surgical treatment is not more than 10% higher compared to standard treatment: preoperative biliary drainage. Accounting for a 10% dropout, 105 patients are needed in each arm resulting in a study population of 210 (alpha = 0.95, beta = 0.8). Discussion: The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor. [ABSTRACT FROM AUTHOR]

Our objective was to determine the clinical importance of reinterpretation of radiological investigations performed in a referring hospital and the value of additional investigations in a referral centre. A panel of four experts retrospectively evaluated the technical quality of radiological investigations and made reinterpretation reports, of 78 patients referred with a suspected pancreatic or hepatobiliary malignancy. The value of additional radiological investigations performed in the referral centre was assessed. The quality of ultrasound and CT examinations was sufficient for reinterpretation in (36 of 69) 52% and (42 of 60) 70%, respectively. The reinterpretation reports of the ultrasound investigations were scored as "in accordance" in (30 of 36) 83%, as "minor discordance" in (3 of 36) 8% and as "major discordance" in (3 of 36) 8%. For CT proportions of (29 of 42) 69%, (8 of 42) 19% and (5 of 42) 12%, respectively, were found. Additional ultrasound ( n=55) showed no additional findings in 16%, minor additional findings in 53% and major additional findings in 31% of cases. For additional spiral CT scan ( n=47) results were of 21, 47 and, 32%, respectively. Reinterpretation of ultrasound and CT resulted in a change in treatment strategy for 7 patients (9%). Additional ultrasound or CT resulted in a change in treatment strategy for 24 patients (30%). Improved communication and reinterpretation of radiological investigations may reduce unnecessary referral. [ABSTRACT FROM AUTHOR]

Background: Since esophageal variceal bleeding is associated with a high mortality rate, prevention of bleeding might be expected to result in improved survival. The first trials to evaluate prophylactic sclerotherapy found a marked beneficial effect of prophylactic treatment. These results, however, were not generally accepted because of methodological aspects and because the reported incidence of bleeding in control subjects was considered unusually high. The objective of this study was to compare endoscopic sclerotherapy (ES) with nonactive treatment for the primary prophylaxis of esophageal variceal bleeding in patients with cirrhosis. Methods: 166 patients with esophageal varices grade II, III of IV according to Paquet's classification, with evidence of active or progressive liver disease and without prior variceal bleeding, were randomized to groups receiving ES (n = 84) or no specific treatment (n = 82). Primary end-points were incidence of bleeding and mortality; secondary end-points were complications and costs. Results: During a mean follow-up of 32 months variceal bleeding occurred in 25% of the patients of the ES group and in 28% of the control group. The incidence of variceal bleeding for the ES and control group was 16% and 16% at 1 year and 33% and 29% at 3 years, respectively. The 1-year survival rate was 87% for the ES group and 84% for the control group; the 3-year survival rate was 62% for each group. In the ES group one death occurred as a direct consequence of variceal bleeding compared to 9 in the other group (p = 0.01, log-rank test). Complications were comparable for the two groups. Health care costs for patients assigned to ES were estimated to be higher. Meta-analysis of a large number of trials showed that the effect of prophylactic sclerotherapy is significantly related to the baseline bleeding risk. Conclusion: In the present trial, prophylactic sclerotherapy did not reduce the incidence of bleeding from varices in patients with liver cirrhosis and a low to moderate bleeding risk. Although sclerotherapy lowered mortality attributable to variceal bleeding, overall survival was not affected. The effect of prophylactic sclerotherapy seems dependent on the underlying bleeding risk. A beneficial effect can only be expected for patients with a high risk for bleeding. [ABSTRACT FROM AUTHOR]

Summary: Background: Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified. Methods: We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was reoccurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat. Findings: 12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy. Interpretation: A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high. [ABSTRACT FROM AUTHOR]

Objective: To find out how patients fared after palliative endoscopic biliary drainage for inoperable hilar cholangiocarcinoma Design: Retrospective study Setting: University hospital, the Netherlands Subjects: Between 1992 and 1999, 41 patients who were referred for resection had tumours that were considered unresectable after additional investigations, including an exploratory laparotomy in 16 patients. In all patients, biliary drainage was established by endoscopic retrograde cholangiography (ERCP) and insertion of endoprostheses. Twelve patients also had percutaneous transhepatic biliary drainage (PTBD). Results: The patients who did not have an exploratory laparotomy had fewer complications (1/25) than those who had explorations (4/16). All patients in both groups had one or more long-term complications during follow-up, of which cholangitis, jaundice, and abdominal pain were the most often recorded. In 32 patients, endoprostheses had to be replaced, a mean of 4 times. Median survival was 9 months, with no significant difference between the groups (8 and 11 months). Adjuvant radiotherapy had no influence on survival. Conclusion: The patients in this series had relatively long survival times, during which they had a substantial number of complications predominantly related to biliary drainage. Because biliary-enteric bypass operations result in effective relief of symptoms and excellent palliation, we suggest that when an exploration is done for patients with type III and IV tumours, a bypass should be made. [ABSTRACT FROM AUTHOR]

Objective: To measure the concentrations of endotoxin and inflammatory mediators during an attack of acute cholangitis and see what effect endoscopic treatment had on these mediators. Design: Prospective study. Setting: University teaching hospital The Netherlands. Subjects: Ten patients with acute cholangitis. Interventions: Measurements were made during the attack and 1 week after endoscopic treatment. Main outcome measure: Changes in clinical variables, and severity of biliary obstruction. Concentrations of endotoxin, cytokines, and endotoxin binding proteins, in plasma. Results: The causes of cholangitis were obstructed endoprosthesis (n = 4) and stones (n = 6). The median bilirubin concentration during the attack was 70.0 μmol/L (range 14-156) and 14.5 μmol/L (range 9-80) after treatment (p < 0.05). Median (range) plasma endotoxin concentrations were 3.6 pg/ml (3.2-107) and 3.6 (2.4-5), respectively. Concentrations of cytokines were high during the acute attack and significantly lower after treatment: median tumour necrosis factor (TNF) fell from 44.6 pg/ml (range 1.2-403) to 7.3 (0-53); soluble TNF receptor p55 from 4.9 ng/ml (2.7-13.8) to 3.6 (1.4-8.2) and TNF receptor p75 from 11.6 ng/ml (7.1-40.6) to 8.1 (2.9-31.3); interleukin 6 (IL-6) fell from 690 pg/ml (34.1-4594) to 8.2 (0-39.3), IL-8 from 226.2 pg/ml (31.6-712.7) to 21.4 (4.2-63.5) and IL-10 from 33.4 pg/ml (2.7-5605) to 4.7 (0-16.7) (p < 0.03). Values for lipopolysaccharide binding protein and soluble CD14 also fell significantly (p < 0.01) from 86.5 (43.4-200) to 21.5 (11.3-37.5) and from 200 (59-200) to 47.8 (0.47-200), respectively. The concentration of bactericidal permeability increasing protein did not change significantly, being 7.1 (2-18.9) during the acute attack and 4.6 (0.8-17.7) a week later. Conclusion: There is a considerable systemic inflammatory response during cholangitis, which is dramatically reduced one week after endoscopic treatment. [ABSTRACT FROM AUTHOR]

Background: Liver surgery in perihilar cholangiocarcinoma (PHC) is associated with high postoperative morbidity because the tumor typically causes biliary obstruction. Preoperative biliary drainage is used to create a safer environment prior to liver surgery, but biliary drainage may be harmful when severe drainage-related complications deteriorate the patients' condition or increase the risk of postoperative morbidity. Biliary drainage can cause cholangitis/cholecystitis, pancreatitis, hemorrhage, portal vein thrombosis, bowel wall perforation, or dehydration. Two methods of preoperative biliary drainage are mostly applied: endoscopic biliary drainage, which is currently used in most regional centers before referring patients for surgical treatment, and percutaneous transhepatic biliary drainage. Both methods are associated with severe drainage-related complications, but two small retrospective series found a lower incidence in the number of preoperative complications after percutaneous drainage compared to endoscopic drainage (18-25% versus 38-60%, respectively). The present study randomizes patients with potentially resectable PHC and biliary obstruction between preoperative endoscopic or percutaneous transhepatic biliary drainage.Methods/design: The study is a multi-center trial with an "all-comers" design, randomizing patients between endoscopic or percutaneous transhepatic biliary drainage. All patients selected to potentially undergo a major liver resection for presumed PHC are eligible for inclusion in the study provided that the biliary system in the future liver remnant is obstructed (even if they underwent previous inadequate endoscopic drainage). Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy. The study is designed to detect superiority of percutaneous drainage: a provisional sample size of 106 patients is required to detect a relative decrease of 50% in the number of severe preoperative complications (alpha = 0.95; beta = 0.8). Interim analysis after inclusion of 53 patients (50%) will provide the definitive sample size. Secondary outcome measures encompass the success of biliary drainage, quality of life, and postoperative morbidity and mortality.Discussion: The DRAINAGE trial is designed to identify a difference in the number of severe drainage-related complications after endoscopic and percutaneous transhepatic biliary drainage in patients selected to undergo a major liver resection for perihilar cholangiocarcinoma.Trial Registration: Netherlands Trial Register [ NTR4243 , 11 October 2013]. [ABSTRACT FROM AUTHOR]

Compares the performance of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction in the Netherlands. Etiology of obstructive jaundice; Subjects; Evaluation of survival and late complications associated with having metal stents or polyethylene stents; Factors influencing stent patency; Mechanisms of stent clogging.

Background and Study Aims:  Recent literature suggests that chemo(radio)therapy might reduce the patency of plastic stents in patients with malignant biliary obstruction. Whether this might also be valid for other types of stents is unknown. The aim of this study was to determine the influence of chemo(radio)therapy on the patency of fully-covered self-expandable metal stents (FCSEMSs) and plastic stents., Patients and Methods:  We retrospectively reviewed the electronic medical records of patients with distal malignant biliary obstruction who underwent biliary stent placement between April 2001 and July 2015. Primary outcome was duration of stent patency. Secondary outcome was stent patency at 3 and 6 months. We used Kaplan-Meier survival analyses to compare stent patency rates between patients who received chemo(radio)therapy and patients who did not., Results:  A total of 291 biliary stents (151 metal and 140 plastic) were identified. The median cumulative stent patency of FCSEMSs did not differ between patients receiving chemo(radio)therapy (n = 51) and those (n = 100) who did not ( P  = 0.70, log-rank test). The estimated cumulative stent patency of plastic stents was also comparable in 99 patients without and 41 patients with chemo(radio)therapy ( P  = 0.73, log-rank test). At 3 and 6 months, FCSEMS patency rates were 87 % and 83 % in patients without chemo(radio)therapy and 96 % and 83 % in patients with therapy, respectively. Plastic patency rates were 69 % and 55 % in patients without and 85 % and 39 % in patients with therapy, respectively. After 1 year, 78 % of the FCSEMSs were still patent in patients without chemo(radio)therapy and 69 % of the FCSEMSs were still patent in patients with therapy., Conclusion:  Our data indicate that chemo(radio)therapy does not reduce the patency of biliary fully-covered metal and plastic stents.

Aim: To provide an overview of the clinical outcomes of self-expandable metal stent (SEMS) placement for malignant gastric outlet obstruction (MGOO)., Methods: A systematic literature search was performed in PubMed of the literature published between January 2009 and March 2015. Only prospective studies that reported on the clinical success of stent placement for MGOO were included. The primary endpoint was clinical success, defined according to the definition used in the original article. Data were pooled and analyzed using descriptive statistics. Subgroup analyses were performed for partially covered SEMSs (PCSEMSs) and uncovered SEMSs (UCSEMSs) using Fisher's exact test., Results: A total of 19 studies, including 1281 patients, were included in the final analysis. Gastric (42%) and pancreatic (37%) cancer were the main causes of MGOO. UCSEMSs were used in 76% of patients and PCSEMSs in 24%. The overall pooled technical success rate was 97.3% and the clinical success rate was 85.7%. Stent dysfunction occurred in 19.6% of patients, mainly caused by re-obstruction (12.6%) and stent migration (4.3%), and was comparable between PCSEMSs and UCSEMSs (21.2% vs 19.1%, respectively, P = 0.412). Re-obstruction was more common with UCSEMSs (14.9% vs 5.1%, P < 0.001) and stent migration was more frequent after PCSEMS placement (10.9% vs 2.2%, P < 0.001). The overall perforation rate was 1.2%. Bleeding was reported in 4.1% of patients, including major bleeding in 0.8%. The median stent patency ranged from 68 to 307 d in five studies. The median overall survival ranged from 49 to 183 d in 13 studies., Conclusion: The clinical outcomes in this large population showed that enteral stent placement was feasible, effective and safe. Therefore, stent placement is a valid treatment option for the palliation of MGOO.