Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head

ISRCTN	ISRCTN38973832
DOI	https://doi.org/10.1186/ISRCTN38973832
Secondary identifying numbers	SDGC 01/2009

Submission date: 21/04/2009
Registration date: 30/04/2009
Last edited: 28/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Christoph Seiler
Scientific

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)6221 56 6986
Email	Christoph.Seiler@med.uni-heidelberg.de

Study information

Study design	Prospective randomised controlled observer and patient blinded multicentre surgical trial with two parallel study groups
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head: a randomised controlled multicentre trial
Study acronym	ChroPac
Study hypothesis	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.
Ethics approval(s)	Ethics Committee of the University of Heidelberg, approved on 20/04/2009 (ref: S-029/2009)
Condition	Chronic pancreatitis
Intervention	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.
Intervention type	Other
Primary outcome measure	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%.
Secondary outcome measures	Exploratory analyses
Overall study start date	18/05/2009
Overall study end date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	200
Participant inclusion criteria	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
Participant exclusion criteria	Participation in another intervention-trial with interference of intervention and outcome of this study
Recruitment start date	18/05/2009
Recruitment end date	30/06/2013

Locations

Countries of recruitment

Germany
Netherlands
Slovenia
United Kingdom

Study participating centre

Im Neuenheimer Feld 110

Heidelberg
69120
Germany

Sponsor information

Study Centre of the German Surgical Society (SDGC) (Germany)
Research organisation

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)6221 56 6986
Email	Markus.Buechler@med.uni-heidelberg.de
Website	http://www.klinikum.uni-heidelberg.de/Studienzentrum-der-Deutschen-Gesellschaft-fuer-Chirurgie-SDGC.6107.0.html
"ROR"	https://ror.org/00ew91p29

Funders

Funder type

Research council

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: ChroPac SE 1682/2-1)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/04/2010		Yes	No
Results article	results	09/09/2017		Yes	No

Editorial Notes

28/08/2018: Publication reference added.