Dataset Information

Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.

ABSTRACT:

Background

It is unclear whether plastic or metal stents are more suitable for preoperative biliary decompression in pancreatic cancer. The objective of this study was to compare the rate of endoscopic reinterventions in patients with pancreatic cancer undergoing plastic or self-expandable metal stent (SEMS) placements for preoperative biliary decompression.

Methods

This was a retrospective study of all patients with obstructive jaundice secondary to pancreatic head cancer who underwent their index endoscopic retrograde cholangiopancreatography (ERCP) and all follow-up biliary stent placements at our center before undergoing pancreaticoduodenectomy. Plastic or SEMS were placed at ERCP for biliary decompression. The main outcome measure was to compare the rate of endoscopic reinterventions between the plastic and SEMS cohorts.

Results

29 patients who underwent pancreaticoduodenectomy had preoperative biliary stent placement (18 plastic, 11 SEMS) at our center. Whereas none of the 11 patients who underwent SEMS placement had stent dysfunction, 7 of 18 (39%) patients with plastic stents required endoscopic reintervention before surgery (P=0.02). Reinterventions were due to cholangitis (n=1) or persistent elevation in serum bilirubin levels (n=6). Two patients with SEMS underwent EUS-guided fine-needle aspiration after ERCP, which yielded a positive diagnosis of cancer in all cases; SEMS did not impair visualization of the tumor mass at EUS. Pancreaticoduodenectomy was undertaken successfully in all 29 patients and the presence of a SEMS did not interfere with biliary anastomosis. On univariate logistic regression, only SEMS placement was associated with less need for endoscopic reintervention (P=0.02).

Conclusions

SEMS are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.

SUBMITTER: Decker C

PROVIDER: S-EPMC3116134 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Publications

Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.

Decker Christopher C Christein John D JD Phadnis Milind A MA Wilcox C Mel CM Varadarajulu Shyam S

Surgical endoscopy 20110304 7

<h4>Background</h4>It is unclear whether plastic or metal stents are more suitable for preoperative biliary decompression in pancreatic cancer. The objective of this study was to compare the rate of endoscopic reinterventions in patients with pancreatic cancer undergoing plastic or self-expandable metal stent (SEMS) placements for preoperative biliary decompression.<h4>Methods</h4>This was a retrospective study of all patients with obstructive jaundice secondary to pancreatic head cancer who und ...[more]

PMID: 21373939

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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.

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.

Dataset Information

Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.

Background

Methods

Results

Conclusions

Publications

Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer.

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