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Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study.

ABSTRACT: BACKGROUND AND STUDY AIMS?:Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities. PATIENTS AND METHODS?:In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group.?The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications. RESULTS:?The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19?% vs. 0?%; P ?=?0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72?% vs. 52?%), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12?% vs. 3.7?%); however, none of these differences in postoperative adverse events reached statistical significance. CONCLUSION:?This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile drainage, as assessed by the amount of bacteria in the intraoperatively collected bile. However, some data in favor of SEMS were observed among the clinical secondary outcomes variables (preoperative stent exchange rates) without increases in local inflammatory reactions.

SUBMITTER: Olsson G

PROVIDER: S-EPMC5585071 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study.

Olsson Greger G Frozanpor Farshad F Lundell Lars L Enochsson Lars L Ansorge Christoph C Del Chiaro Marco M Reuterwall-Hansson Marcus M Shetye Alysha A Arnelo Urban U

Endoscopy international open 20170905 9

<h4>Background and study aims</h4>Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective ...[more]

PMID: 28879225

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Project description:BackgroundThe occurrence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) after using covered self-expandable metallic stents (CSEMS) and multiple plastic stents (MPS) in the therapy of benign biliary strictures (BBS) remains ambiguous, this analysis aimed to evaluate the outcomes.MethodsA systematic search of electronic databases (PubMed, Web of Science and Cochrane Library) was conducted for randomised controlled trials (RCTs), and the included studies were published between 2008 and 2021. The primary outcome was PEP, while the secondary outcomes were stricture resolution, recurrence, overall adverse events, costs, and ERCP sessions. Pooled effect sizes were calculated with the random-effects model or fixed-effects model depending on the heterogeneity.ResultsSix RCTs contained 444 patients (221 with CSEMS, 223 with MPS) finally included in the meta-analysis. The present analysis shows that compared to MPS, PEP is more likely to occur in CSEMS (OR [odds ratio] = 3.34, 95% confidence intervals [CI]:1.44-7.77, p = .005). CSEMS needs fewer ERCP sessions (Mean Deviation [MD]: -1.56; 95%CI:-2.66, -0.46], p = .006). The difference in stricture resolution and recurrence was not significant between the two stent types (OR = 0.87, 95%CI: 0.49-1.56, p = .64; and OR = 2.3, 95%CI: 0.68-7.76, p = .18). The incidence of overall adverse events was comparable between CSEMS and the MPS group (OR = 1.49, 95% CI: 0.97-2.29, p = .07).ConclusionsCompared with MPS, CSEMS caused a significantly higher incidence of PEP but fewer ERCP procedures, while the rate of stricture resolution, recurrence, and overall adverse events were comparable. Prevention methods of PEP should be further evaluated in BBS when undergoing CSEMS placement.Systematic review registrationPROSPERO CRD42022314864. Key messagesCSEMS and MPS placement remain a mainstay for patients with BBS, and severe complications after stent placement have not been compared.The incidence of PEP was higher after deployment of CSEMS compared to MPS.Prevention methods of PEP should be evaluated in BBS when undergoing CSEMS placement.

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.

Project description:We posed six clinical questions (CQ) on preoperative biliary drainage and organized all pertinent evidence regarding these questions. CQ 1. Is preoperative biliary drainage necessary for patients with jaundice? The indications for preoperative drainage for jaundiced patients are changing greatly. Many reports state that, excluding conditions such as cholangitis and liver dysfunction, biliary drainage is not necessary before pancreatoduodenectomy or less invasive surgery. However, the morbidity and mortality of extended hepatectomy for biliary cancer is still high, and the most common cause of death is hepatic failure; therefore, preoperative biliary drainage is desirable in patients who are to undergo extended hepatectomy. CQ 2. What procedures are appropriate for preoperative biliary drainage? There are three methods of biliary drainage: percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD) or endoscopic retrograde biliary drainage (ERBD), and surgical drainage. ERBD is an internal drainage method, and PTBD and ENBD are external methods. However, there are no reports of comparisons of preoperative biliary drainage methods using randomized controlled trials (RCTs). Thus, at this point, a method should be used that can be safely performed with the equipment and techniques available at each facility. CQ 3. Which is better, unilateral or bilateral biliary drainage, in malignant hilar obstruction? Unilateral biliary drainage of the future remnant hepatic lobe is usually enough even when intrahepatic bile ducts are separated into multiple units due to hilar malignancy. Bilateral biliary drainage should be considered in the following cases: those in which the operative procedure is difficult to determine before biliary drainage; those in which cholangitis has developed after unilateral drainage; and those in which the decrease in serum bilirubin after unilateral drainage is very slow. CQ 4. What is the best treatment for post-drainage fever? The most likely cause of high fever in patients with biliary drainage is cholangitis due to problems with the existing drainage catheter or segmental cholangitis if an undrained segment is left. In the latter case, urgent drainage is required. CQ 5. Is bile culture necessary in patients with biliary drainage who are to undergo surgery? Monitoring of bile cultures is necessary for patients with biliary drainage to determine the appropriate use of antibiotics during the perioperative period. CQ 6. Is bile replacement useful for patients with external biliary drainage? Maintenance of the enterohepatic bile circulation is vitally important. Thus, preoperative bile replacement in patients with external biliary drainage is very likely to be effective when highly invasive surgery (e.g., extended hepatectomy for hilar cholangiocarcinoma) is planned.

Dataset Information

Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study.

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Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study.

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