Condition category
Digestive System
Date applied
21/04/2009
Date assigned
30/04/2009
Last edited
29/07/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christoph Seiler

ORCID ID

Contact details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6986
Christoph.Seiler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SDGC 01/2009

Study information

Scientific title

Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head: a randomised controlled multicentre trial

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

Ethics Committee of the University of Heidelberg, approved on 20/04/2009 (ref: S-029/2009)

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

18/05/2009

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Both

Target number of participants

200

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

Trial participating centre

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Sponsor information

Organisation

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

Sponsor details

Klinik für Allgemein-
Viszeral- und Transplantationschirurgie
Universität Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6986
Markus.Buechler@med.uni-heidelberg.de

Sponsor type

Research organisation

Website

http://www.klinikum.uni-heidelberg.de/Studienzentrum-der-Deutschen-Gesellschaft-fuer-Chirurgie-SDGC.6107.0.html

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20429912

Publication citations

  1. Protocol

    Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM, ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial., Trials, 2010, 11, 47, doi: 10.1186/1745-6215-11-47.

Additional files

Editorial Notes