title: Preparing for prospective clinical trials: a national initiative of an excellence registry for consecutive pancreatic cancer resections.
abstract: BACKGROUND
  Despite significant improvements in perioperative mortality as well as response rates to multimodality treatment, results after surgical resection of pancreatic adenocarcinoma with respect to long-term outcomes remain disappointing. Patient recruitment for prospective international trials on adjuvant and neoadjuvant regimens is challenging for various reasons. We set out to assess the preconditions and potential to perform perioperative trials for pancreatic cancer within a well-established Austrian nationwide network of surgical and medical oncologists (Austrian Breast & Colorectal Cancer Study Group).
  
  
  METHODS
  From 2005 to 2010 five high-volume centers and one medium-volume center completed standardized data entry forms with 33 parameters (history and patient related data, preoperative clinical staging and work-up, surgical details and intraoperative findings, postoperative complications, reinterventions, reoperations, 30-day mortality, histology, and timing of multimodality treatment). Outside of the study group, in Austria pancreatic resections are performed in three “high-volume” centers (>10 pancreatic resections per year), three “medium-volume” centers (5–10 pancreatic resections per year), and the rest in various low-volume centers (<5 pancreatic resections per year) in Austria. Nationwide data for prevalence of and surgical resections for pancreatic adenocarcinoma were contributed by the National Cancer Registry of Statistics of Austria and the Austrian Health Institute.
  
  
  RESULTS
  In total, 492 consecutive patients underwent pancreatic resection for ductal adenocarcinoma. All postoperative complications leading to hospital readmission were treated at the primary surgical department and documented in the database. Overall morbidity and pancreatic fistula rate were 45.5 % and 10.1 %, respectively. Within the entire cohort there were 9.8 % radiological reinterventions and 10.4 % reoperations. Length of stay was 16 days in median (0–209); 12 of 492 patients died within 30 days after operation, resulting in a 30-day mortality rate of 2.4 %. Seven of the total 19 deaths (36.8 %) occurred after 30 days, during hospitalization at the surgical department, resulting in a hospital mortality rate of 3.9 % (19/492). With a standardized histopathological protocol, there were 70 % (21/30) R0 resections, 30 % (9/30) R1 resections, and no R2 resections in Vienna and 62.7 % (32/51) R0 resections, 35.3 % (18/51) R1 resections, and 2 % (1/51) R2 resections in Salzburg. Resection margin status with nonstandardized protocols was classified as R0 in 82 % (339/411), R1 in 16 % (16/411), and R2 in 1.2 % (5/411). Perioperative chemotherapy was administered in 81.1 % of patients (8.3 % neoadjuvant; 68.5 % adjuvant; 4.3 % palliative); chemoradiotherapy (1.6 % neoadjuvant; 3 % adjuvant; 0.2 % palliative), in 4.9 % of patients. The six centers that contributed to this registry initiative provided surgical treatment to 40 % of all Austrian patients, resulting in a median annual recruitment of 85 (51–104) patients for the entire ABCSG-group and a median of 11.8 (0–38) surgeries for each individual department.
  
  
  CONCLUSIONS
  Surgical quality data of the ABCSG core pancreatic group are in line with international standards. With continuing centralization the essential potential to perform prospective clinical trials for pancreatic adenocarcinoma is given in Austria. Several protocol proposals aiming at surgical and multimodality research questions are currently being discussed
authors.forename: Odo
authors.initials: O
authors.lastname: Gangl
authors.forename: Klaus
authors.initials: K
authors.lastname: Sahora
authors.forename: Peter
authors.initials: P
authors.lastname: Kornprat
authors.forename: Christian
authors.initials: C
authors.lastname: Margreiter
authors.forename: Florian
authors.initials: F
authors.lastname: Primavesi
authors.forename: Evelyne
authors.initials: E
authors.lastname: Bareck
authors.forename: Martin
authors.initials: M
authors.lastname: Schindl
authors.forename: Friedrich
authors.initials: F
authors.lastname: Längle
authors.forename: Dietmar
authors.initials: D
authors.lastname: Öfner
authors.forename: Hans-Jörg
authors.initials: HJ
authors.lastname: Mischinger
authors.forename: Johann
authors.initials: J
authors.lastname: Pratschke
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
authors.forename: Reinhold
authors.initials: R
authors.lastname: Függer
mesh_terms: D000230:Adenocarcinoma / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001317:Austria; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D016577:Pancreaticoduodenectomy; D018579:Patient Selection; D012042:Registries; D012086:Reoperation / Q000706:statistics & numerical data