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ISRCTN
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ISRCTN38973832
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ClinicalTrials.gov identifier
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Public title
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Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head
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Scientific title
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Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head: a randomised controlled multicentre trial
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Acronym
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ChroPac
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Serial number at source
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SDGC 01/2009
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Study hypothesis
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The two-sided null-hypothesis states that both surgical interventions lead to the same average quality of life (QoL) scores during 24 months after surgery. The two-sided alternative-hypothesis states that the two interventions perform differently in terms of the primary efficacy endpoint.
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Lay summary
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Ethics approval
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Ethics Committee of the University of Heidelberg, approved on 20/04/2009 (ref: S-029/2009)
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Study design
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Prospective randomised controlled observer and patient blinded multicentre surgical trial with two parallel study groups
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Countries of recruitment
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Germany, Netherlands, Slovenia, United Kingdom
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Disease/condition/study domain
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Chronic pancreatitis
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Participants - inclusion criteria
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1. Patients (no age or gender restrictions) with chronic pancreatitis of the head and pain, eligible for elective surgical resection
2. Ability of subject to understand character and individual consequences of the clinical trial
3. Written informed consent
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Participants - exclusion criteria
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Participation in another intervention-trial with interference of intervention and outcome of this study
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Anticipated start date
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18/05/2009
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Anticipated end date
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30/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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Experimental intervention:
Any surgical technique that removes inflamed pancreatic tissue of the head without resection of the duodenum (e.g. Beger, Frey or Berne procedure).
Control intervention:
Pylorus preserving/classic Whipple procedure.
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Primary outcome measure(s)
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Average QoL during 24 months after surgery, measured 6, 12 and 24 months after surgery by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) scale "physical functioning". The primary efficacy analysis will be conducted for the intention-to-treat population. An analysis of covariance (ANCOVA) model will be applied for the intervention group comparison adjusting for age, centre and EORTC QLQ-C30 scale "physical functioning" before surgery. The level of significance is set at 5% (two-sided) and sample size is determined to assure a power of 1-beta = 90%.
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Secondary outcome measure(s)
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Exploratory analyses
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Sources of funding
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German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: ChroPac SE 1682/2-1)
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Trial website
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Publications
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2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20429912
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Contact name
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Dr
Christoph
Seiler
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 (0)6221 56 6986
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Fax
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+49 (0)6221 56 6988
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Email
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Christoph.Seiler@med.uni-heidelberg.de
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Sponsor
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Study Centre of the German Surgical Society (SDGC) (Germany)
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Address
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Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 (0)6221 56 6986
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Fax
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+49-(0)6221 56 6988
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Email
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Markus.Buechler@med.uni-heidelberg.de
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Sponsor website:
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http://www.klinikum.uni-heidelberg.de/Studienzentrum-der-Deutschen-Gesellschaft-fuer-Chirurgie-SDGC.6107.0.html
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Date applied
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21/04/2009
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Last edited
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29/07/2010
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Date ISRCTN assigned
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30/04/2009
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