International journal of surgery protocols · 2016
Short- versus long-term complementary nutritional support via needle catheter jejunostomy after pancreaticoduodenectomy: Study protocol of a randomized controlled trial.
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Müller Philip C, Probst Pascal, Moltzahn Felix, Steinemann Daniel C, Pärli Michael S, Schmid Stefan W, Müller Sascha A, Z'graggen Kaspar
Аннотация
INTRODUCTION: Pancreatic resection is the only curative treatment for pancreatic cancer. Due to tumor cachexia most patients present with a weight loss at the time of diagnosis. Postoperatively the weight loss is often intensified. Tumor cachexia has an influence on the post-operative morbidity and mortality and on the overall survival. Complementary nutrition has a benefit on the mentioned issues. Needle catheter jejunostomy (NCJ) offers a well-tolerated and safe way for additional nutrition therapy. Until today, the optimal length of postoperative supplementary nutrition has not been evaluated.
METHODS AND ANALYSIS: The study is designed as a randomized controlled trial to compare the effect of complementary nutritional support until discharge and until 8-weeks after discharge for patients after pancreaticoduodenectomy (PD). The primary endpoint is the comprehensive complications index assessed 12 weeks postoperatively. The grading of the complications will be performed by a blinded assessor. The secondary endpoints are: quality of life, a nutritional assessment and the assessment of the effect on adjuvant therapies and 5-year survival. Follow-up visits are planned 1-, 3-, 6-, 12- and 60 month postoperatively. A total sample size of 140 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat principle.
ETHICS AND DISSEMINATION: The ethics committee of the University of Bern reviewed and approved this study on 22.08.2016 (KEK BE 322/14). The trial was registered in the German Clinical Trial Register (DRKS00010237) on 25.08 2016. The present trial is the first study comparing short- and long-term complementary nutritional support after PD in randomized controlled study. The results will allow a postoperative nutritional therapy after PD based on high quality data. The results will be presented at relevant surgical conferences and written publications of the short-term results and long-term oncologic results are planned within surgical journals.
METHODS AND ANALYSIS: The study is designed as a randomized controlled trial to compare the effect of complementary nutritional support until discharge and until 8-weeks after discharge for patients after pancreaticoduodenectomy (PD). The primary endpoint is the comprehensive complications index assessed 12 weeks postoperatively. The grading of the complications will be performed by a blinded assessor. The secondary endpoints are: quality of life, a nutritional assessment and the assessment of the effect on adjuvant therapies and 5-year survival. Follow-up visits are planned 1-, 3-, 6-, 12- and 60 month postoperatively. A total sample size of 140 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat principle.
ETHICS AND DISSEMINATION: The ethics committee of the University of Bern reviewed and approved this study on 22.08.2016 (KEK BE 322/14). The trial was registered in the German Clinical Trial Register (DRKS00010237) on 25.08 2016. The present trial is the first study comparing short- and long-term complementary nutritional support after PD in randomized controlled study. The results will allow a postoperative nutritional therapy after PD based on high quality data. The results will be presented at relevant surgical conferences and written publications of the short-term results and long-term oncologic results are planned within surgical journals.