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Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

Authors: Markus K Diener, Thomas Bruckner, Pietro Contin, Christopher Halloran, Matthias Glanemann, Hans Jürgen Schlitt, Joachim Mössner, Meinhard Kieser, Jens Werner, Markus W Büchler, Christoph M Seiler

Published in: Trials | Issue 1/2010

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Abstract

Background

A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed.

Methods/Design

ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy) in patients with chronic pancreatitis of the pancreatic head.
ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided) and sample size (n = 100 per group) is determined to assure a power of 90%.

Discussion

The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system). Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis.

Trial registration

Controlled-trials.com ISRCTN38973832
Appendix
Available only for authorised users
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Metadata
Title
ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial
Authors
Markus K Diener
Thomas Bruckner
Pietro Contin
Christopher Halloran
Matthias Glanemann
Hans Jürgen Schlitt
Joachim Mössner
Meinhard Kieser
Jens Werner
Markus W Büchler
Christoph M Seiler
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-47

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