Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head - A randomized controlled multicentre trial. ChroPac

• Applicant: Professor Dr. Markus K. Diener
• Subject Area: General and Visceral Surgery
• Term: from 2009 to 2017
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 73500506

Patients with intractable pain due to chronic inflammation of the pancreatic head often suffer from local complications (stenosis of the duodenum, common bile duct, pancreatic duct) which necessitate surgical treatment. Since data from our systematic review and a meta-analysis detected a better Quality of Life (QoL) for the duodenumpreserving pancreatic head resection techniques compared to the Whipple procedure without an increased morbidity or mortality, ChroPac trial was designed (randomized controlled observer and patient blinded) to investigate differences in QoL within two years measured by the EORTC-QLQ-C30 physical score 6, 12, 18 and 24 months after surgery. Sample size calculation is based on a mean difference of 10% with an estimated standard deviation of 20%. With a level of significance of 5 % and a power of 90 % 86 patients are needed per treatment group. Assuming drop outs a total of 200 patients need to be randomized. Based on the intention-to-treat population a fixed effects linear model adjusting for age, gender, center and QoL before surgery will be used for analysis. The trial is conducted using the established infrastructures of the Study Centre of the German Surgical Society and recruitment was planned within the functioning Distal Pancreatectomy (DISPACT) Trial Group. First patient (FPI) was randomized on June 10th, 2009. However, recruitment after one year was behind schedule due to the following reasons: larger fraction of patients treated by gastroenterological therapy like stent implantation, exclusion because of malignant tumor or secondary intervention, patient not suited for both interventions. With implementation of a number of measures like a specific investigator meeting, initiation of additional trial centers, information to scientific community as well as patients and lay people, we were able to improve recruitment. By the first quarter of 2011 recruitment rates could be enhanced to the originally scheduled numbers with 19 active centers (compared to 11 centers planned). To date 163 of 200 patients have been randomized and thus, completion of recruitment is feasible until the end of the first quarter 2012. So far, no problems emerged concerning the conduct or safety aspects of the trial. According to trial protocol the safety report 2009/2010 has been compiled and sent to the DSMB. Regarding the reported SAEs no change in the risk-benefit assessment was seen. Documentation is excellent with near to or above 90% completeness during the last twelve months, showing an outstanding performance of the trial group.

• DFG Programme: Clinical Trials
• Participating Person: Professor Dr. Markus W. Büchler