Dataset Information

Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction.

ABSTRACT:

Background

Relieving malignant biliary obstruction improves quality of life and permits chemotherapy. Outcomes of endoscopic retrograde cholangio-pancratography(ERCP) in inoperable malignant biliary obstruction have been examined in a national cohort to establish factors associated with poor outcomes.

Methods

Hospital Episode Statistics include diagnostic and procedural data for all NHS hospital attendances in England. Patients from 2006 to 2017 with a Hepaticopancreaticobiliary (HPB) malignancy who had undergone ERCP were studied. Patients undergoing a potentially curative operation were excluded. Associations between demographics, co-morbidities, unit ERCP volume and mortality were examined by logistic regression.

Findings

39,702 patients were included; 49.4% were male; median age was 75 (IQR 66-88)years. Pancreatic cancer was the most common tumour (63.9%). Mortality was 4.1%, 9.7% and 19.1% for 7-day, in hospital and 30-day respectively. On multivariable analysis: men (OR 1.20(95%CI 1.14-1.26), p < 0.001); increasing age quintile 78-83(1.73(1.59-1.89), p < 0.001), >83(2.70(2.48-2.94),p < 0.001); most deprived quintile (1.21(1.11-1.32), p < 0.001); increasing co-morbidity score >20(3.36(2.94-3.84),p < 0.001); small bowel malignancy (1.45(1.22-1.72), p < 0.001), intrahepatic biliary malignancy(1.10(1.03-1.17), p = 0.005) and year of ERCP 2006/07 (1.37(1.22-1.55), p < 0.001) were associated with increased 30-day mortality. Extrahepatic biliary tree cancers (0.67(0.61-0.73), p<0.001), high volume providers of ERCP (>318 annually, 0.91(0.84-0.98), p = 0.01) and high volume of ERCP for malignant obstruction (>40 annually (0.91(0.85-0.98), p = 0.014) were negatively associated with 30-day mortality. Patients were less likely to require a second ERCP in high volume providers (>318, 8.0%) compared to low volume ((<204, 13.4%), p<0.001).

Interpretation

Short term mortality in patients with malignant biliary obstruction following ERCP was high. 30-day mortality was positively associated with increasing age and co-morbidity, men, deprivation, and earlier year of ERCP and negatively with extrahepatic biliary tree cancer and high volume ERCP providers.

Funding

Internal funding only.

SUBMITTER: Harvey PR

PROVIDER: S-EPMC6948226 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction.

Harvey Philip R PR Baldwin Simon S Mytton Jemma J Dosanjh Amandip A Evison Felicity F Patel Prashant P Trudgill Nigel J NJ

EClinicalMedicine 20200103

<h4>Background</h4>Relieving malignant biliary obstruction improves quality of life and permits chemotherapy. Outcomes of endoscopic retrograde cholangio-pancratography(ERCP) in inoperable malignant biliary obstruction have been examined in a national cohort to establish factors associated with poor outcomes.<h4>Methods</h4>Hospital Episode Statistics include diagnostic and procedural data for all NHS hospital attendances in England. Patients from 2006 to 2017 with a Hepaticopancreaticobiliary ( ...[more]

PMID: 31922117

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Project description:BackgroundBiliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction.MethodsThis post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring re-intervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment.ResultsSEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths.ConclusionsThis newly designed and marketed biliary SEMS system appears to be effective at relieving biliary obstruction and preventing re-intervention within 6 months of insertion in the overwhelming majority of patients. The device has an excellent safety profile, and associated high technical success rate during deployment.Trial registrationThe study was registered on clinicaltrials.gov on 14 October 2013 and the study registration number is NCT01962168. University of Massachusetts Medical School did not participate in the study.

Dataset Information

Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction.

Background

Methods

Findings

Interpretation

Funding

Publications

Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction.

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