Pancreatitis was defined as a three-fold elevation in amylase or lipase or evidence of pancreatic inflammation on imaging. We also collected data regarding whether a given patient actually underwent surgical resection or attempted surgical resection after undergoing neoadjuvant therapy.
The (n) number of stent exchanges in a single patient was also noted, as was time from initial stent placement to surgery and total survival time from initial stent placement. If a patient was lost to follow-up (receiving local care), the date of the last clinical contact at the referral center was used as the end-date for purposes of calculating stent survival time. Statistical methods Continuous data were Inhibitors,research,lifescience,medical summarized Inhibitors,research,lifescience,medical using means and standard deviations (SD) or ranges. Categorical variables were summarized by counts and percentages. Time to stent complication was compared between metal and plastic stents using Kaplan-Meier estimation and log-rank testing with all stents assumed to be independent. Stent complications were assumed to follow a Poisson process. The complication rate was NVP-BKM120 estimated as the ratio of complications to total stent exposure time and 95% confidence intervals were calculated.
A probability (P) value Inhibitors,research,lifescience,medical of 0.05 or smaller was considered significant for all hypothesis tests. The above procedures were done in SAS 9.2 (SAS Institute Inc., Cary, NC). Results 52 patients met inclusion criteria, with a mean age of 65 years (SD 9.58). 54% were male, and 85% were borderline resectable (15% resectable) at initial diagnosis. All Inhibitors,research,lifescience,medical received gemcitabine-based neoadjuvant regimens. A majority (71%) ultimately underwent surgery, whether an aborted operation (23%) or successful resection (48%). In patients eventually undergoing
surgery, the mean time from initial stent placement to surgery was 134.1 days (range, 26-420 days). Only 21% of patients (11 of 52) made it to surgery with their initial stent in place. Of these eleven patients, 7 had a plastic stent and 4 had a metal stent. A total of 113 stents were placed in these 52 patients (70 plastic, 43 metal). Plastic stents were the initial stent placed in 43 patients. There were 9 complications Inhibitors,research,lifescience,medical in 276 months with metal stents in place, compared with 27 complications in 129 months with plastic stents in place. The complication rate was almost 7 times higher with plastic stents, 0.21 (95% CI, not 0.14-0.30), than with metal stents, 0.03 (95% CI, 0.01-0.06). Of the stent complications, nearly 70% involved stents 10 French or larger. Furthermore 67% of complications occurred in patients who ultimately underwent surgery. All 9 metal stent complications were due to stent occlusion, 3 with cholangitis and 1 involving migration. For plastic stents, there were 23 cases of stent occlusion, 15 with cholangitis, 7 stent migrations, and 1 episode of cholecystitis. A total of 15 patients were hospitalized for plastic stent complications, while 5 patients were hospitalized for metal stent complications.