gms | German Medical Science

Introduction: Clinical multicenter-trials are carried out in several phases: Idea ◊ planning/writing of the protocol ◊ ethics approval ◊ initiating other centers ◊ recruiting ◊ follow-up ◊ results. Often the recruiting phase is underestimated. It depends on number of potential patients, on the commitment of participating centers and on the acceptance of the trial by the patients.

Methods: The recruiting for the trial mentioned above between 6/2003 and 5/2005 in one center was analyzed. Primary objective of the study is median survival in locally resectable pancreatic carcinoma. After obtaining informed consent patients are randomized in two arms either Arm A – “operation” or Arm B – “preoperative chemoradiotherapy, and subsequent operation”. Carcinoma must be proven by histology or cytology. Resectability is assessed by CT-scan (major vessels maximally enclosed up to 180° by the tumor).

At an interdisciplinary tumor board all potential patients with a possible malignant pancreatic tumor were registered. Laparoscopy for exclusion of peritoneal spread or small subserous liver metastases was usually only done within the trial and was obligatory until July 2004 (amendment 1). Reason for exclusion from the trial was noted for all registered patients.

Results: At the tumor board 325 patients with “pancreatic disease” were demonstrated with CT/MRT of the abdomen. 127 patients had either a benign disease or a tumor not originating from the pancreas. 23 patients had a tumor recurrence or had already treatment for the pancreatic tumor, 45 patients had a carcinoma of the pancreatic body or tail and 24 patients had an ampullary carcinoma.15 patients had a non-ductal adenocarcinoma of the pancreas. 41 patients had a locally not resectable tumor or metastases. 11 patients were excluded due to severe other diseases or could not give informed consent. 6 patients were excluded because they were older than 75 years. Of the remaining 33 patients 12 patients had to be excluded, because the needle-biopsy showed no malignant tumor. 11 patients didn`t consent and one patient had to be excluded after consenting due to liver metastases diagnosed at laparoscopy. 9 patients were randomised in the trial.

Conclusion: For this trial the recruiting process is tedious. The daily central tumor board is an interdisciplinary platform with great potential for registering all potential patients with possibly malignant tumors of the pancreas. One third of the 33 potiential candidates the needle biopsy showed no malignant tumor. For 6 of theses patients the later operation specimen did not contain tumor. Another third didn`t consent, because they wanted to be operated as soon as possible. So the acceptance of this trial needs to be optimized. Additionally all potential candidates which were not randomized should be observed. This could be done in an extra trials protocol.