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Comparative Efficacy of Various Stents for Palliation in Patients with Malignant Extrahepatic Biliary Obstruction: A Systematic Review and Network Meta-Analysis.

ABSTRACT: Although many studies have investigated the efficacy of stent placement for patients with malignant extrahepatic biliary obstruction, the clinical outcomes and adverse events of biliary stenting have not been comprehensively evaluated. We searched all relevant randomized-controlled trials that evaluated the comparative efficacy of biliary stents, including the plastic stents, uncovered self-expandable metal stents (SEMSs), and covered SEMSs in patients with malignant extrahepatic biliary obstructions. Twenty-one studies with 2326 patients were included. Both uncovered and covered SEMSs had a lower risk of recurrent biliary obstruction (RBO) compared to plastic stents (risk ratio (RR) (95% confidence interval [CI]): uncovered vs. plastic, 0.46 (0.35-0.62); covered vs. plastic, 0.46 (0.34-0.62)). A comparison of the groups using SEMSs revealed that tumor ingrowth was common in the uncovered SEMS group, while stent migration, tumor overgrowth, and occlusion by sludge were common in the covered SEMS group; however, the overall risk of RBO did not differ between these groups (RR (95% CI): uncovered vs. covered: 1.02 (0.80-1.30)). Although the main causes of RBO vary across stents, RBO risk was similar between uncovered and covered SEMS groups. Both SEMSs have superior efficacy in terms of RBO compared to plastic stents.

SUBMITTER: Park CH

PROVIDER: S-EPMC7912345 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Comparative Efficacy of Various Stents for Palliation in Patients with Malignant Extrahepatic Biliary Obstruction: A Systematic Review and Network Meta-Analysis.

Park Chan Hyuk CH Park Se Woo SW Jung Jang Han JH Jung Eun Suk ES Kim Jung Hee JH Park Da Hae DH

Journal of personalized medicine 20210130 2

Although many studies have investigated the efficacy of stent placement for patients with malignant extrahepatic biliary obstruction, the clinical outcomes and adverse events of biliary stenting have not been comprehensively evaluated. We searched all relevant randomized-controlled trials that evaluated the comparative efficacy of biliary stents, including the plastic stents, uncovered self-expandable metal stents (SEMSs), and covered SEMSs in patients with malignant extrahepatic biliary obstruc ...[more]

PMID: 33573288

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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.

Project description:BackgroundRelieving 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.MethodsHospital 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.Findings39,702 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).InterpretationShort 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.FundingInternal funding only.

Project description:AimTo compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor.MethodsWe performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included.ResultsThe analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%).ConclusionsOur meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability.

Dataset Information

Comparative Efficacy of Various Stents for Palliation in Patients with Malignant Extrahepatic Biliary Obstruction: A Systematic Review and Network Meta-Analysis.

Publications

Comparative Efficacy of Various Stents for Palliation in Patients with Malignant Extrahepatic Biliary Obstruction: A Systematic Review and Network Meta-Analysis.

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