Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

BACKGROUND AND STUDY AIMS: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. PATIENTS AND METHODS: A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  RESULTS: Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. CONCLUSIONS: The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634).

Transmural endoscopic necrosectomy of infected pancreatic necroses and drainage of infected pseudocysts: a tailored approach.

OBJECTIVE: Transmural endoscopic drainage and necrosectomy have become favored treatment modes for infected pancreatic pseudocysts and necroses. In this analysis, we summarize the outcome of 40 patients with complicated course of acute pancreatitis after endoscopic treatment. MATERIAL AND METHODS: From January 2006 through May 2011, 40 patients of our department with complicated pancreatitis were included in this retrospective analysis. All patients underwent endosonographic transgastric puncture followed by wire-guided insertion of one or more double pigtail stents. Patients with extensive necroses were treated repeatedly with transgastric necrosectomy. Treatment success was determined by clinical, laboratory, and radiological parameters. RESULTS: Nine patients had interstitial pancreatitis (IP) with pancreatic pseudocysts. Thirty-one patients had necrotizing pancreatitis (NP) with acute pancreatic necroses (n = 4) or walled-off pancreatic necrosis (n = 27). All patients with IP and nine patients with NP had pseudocysts without solid material and underwent transgastric drainage only. In this group major complications occurred in 11.1% and no mortality was observed. Twenty-two NP patients were treated with additional repeated necrosectomy. In patients with localized peripancreatic necroses (n = 10) no need of surgery or mortality was observed, major complications occurred in 10%. In patients with extensive necroses reaching the lower abdomen (n = 12), three needed subsequent surgery and three died. CONCLUSIONS: Transgastric endoscopy is an effective minimally invasive procedure even in patients with advanced pancreatic necroses. Complication rate is low particularly in patients with sole pseudocysts or localized necroses. The extent of the fluid collections and necroses is a new predictive parameter for the outcome of the patients.