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Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis.

ABSTRACT: In endoscopic biliary drainage (EBD) for various benign and malignant biliary disorders, the appropriate timing to replace or change a plastic stent (PS) with a self-expandable metallic stent (SEMS) remains unclear. This study aimed to define the best period to replace or change a PS with a SEMS. Between January 1, 2012, and December 31, 2018, 1,887 consecutive EBD procedures, including 170 SEMS placements, were retrospectively identified. The period to recurrent biliary obstruction (PRBO) was estimated and compared between the malignant and benign groups and according to each disease using time to event analysis and competing risk analysis. Compared with the benign group, the malignant group had significantly shorter median PRBO with interquartile range (IQR) after PS placement [108 (39 - 270) vs. 613 (191 - 1,329) days, P?

SUBMITTER: Chiba M

PROVIDER: S-EPMC7403588 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis.

Chiba Masafumi M Kato Masayuki M Kinoshita Yuji Y Shimamoto Nana N Tomita Youichi Y Abe Takahiro T Kawahara Yosuke Y Koyama Seita S Kanazawa Keisuke K Takakura Kazuki K Tsukinaga Shintaro S Nakano Masanori M Torisu Yuichi Y Toyoizumi Hirobumi H Ikeda Keiichi K Arakawa Hiroshi H Sumiyama Kazuki K

Scientific reports 20200804 1

In endoscopic biliary drainage (EBD) for various benign and malignant biliary disorders, the appropriate timing to replace or change a plastic stent (PS) with a self-expandable metallic stent (SEMS) remains unclear. This study aimed to define the best period to replace or change a PS with a SEMS. Between January 1, 2012, and December 31, 2018, 1,887 consecutive EBD procedures, including 170 SEMS placements, were retrospectively identified. The period to recurrent biliary obstruction (PRBO) was e ...[more]

PMID: 32753642

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Project description:Self-expandable metallic stents (SEMSs) have been widely used in the treatment of malignant central airway obstruction. However, few reports focus on the treatment of atelectasis and how to estimate the prior probability of success via SEMSs placement, This current study aimed to study the safety and effectiveness of SEMSs for the treatment of obstructive atelectasis, and the value of preoperative CT enhancement for ventilation of atelectasis via SEMSs placement. A total of 35 patients with obstructive atelectasis (29 male and 6 female) was included from February 2012 to March 2018. The procedures were performed under fluoroscopic guidance, and bronchoscopic laser resection was performed for severe restenosis cases after SEMSs placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48?h and at 1-, 3-, 6-, and 12-month intervals. Thirty-eight SEMSs were successfully implanted in 34 patients, included 29 Y type tracheal stents, 4 small y stents, and 5 straight airway stents. After stenting, 26 cases showed full ventilation, and 3 cases were partially ventilated. The technical success and clinical success was 97.1% and 82.9%, respectively. A higher maximum enhancement CT value was found in patients with full ventilation. Mean follow-up time was 18.8 ± 4.0 months. Eight cases showed restenosis and received endoscopic laser resection, included 1 case underwent removal and 3 cases received second stenting. There were 2 cases of perioperative non-operative death, and 11 cases of post-discharge death (2 cardiac deaths and 9 malignant tumors). The survival rates of 3 months, 1 year and 2 years were 78.6%, 58.5% and 58.5%, respectively. In conclusion, SEMSs placement is safe and effective for obstructive atelectasis, and the preoperative CT enhancement played an important role in estimating the prior probability of success in the treatment of atelectasis via SEMSs placement.

Project description:Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution.Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N?=?112) due to orthotopic liver transplant (n?=?73), chronic pancreatitis (n?=?35), or postoperative injury (n?=?4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded.Patients (N?=?112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence.Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of -15%.There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, -3.0% to ?; P?<?.001). Given the prespecified noninferiority margin of -15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P?<?.001).Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these.clinicaltrials.gov Identifier: NCT01221311.

Project description: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.

Dataset Information

Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis.

Publications

Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis.

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