Clinical trial to compare duodenum preserving pancreatic head resection according to Beger versus the Berne modification in patients with chronic pancreatitis: a randomised controlled trial

ISRCTN	ISRCTN50638764
DOI	https://doi.org/10.1186/ISRCTN50638764
Protocol serial number	KSC 06/2003
Sponsor	University of Heidelberg Medical School (Germany)
Funder	University of Heidelberg Medical School (Germany)

Submission date: 27/05/2004
Registration date: 01/09/2004
Last edited: 30/08/2011

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 of protocol

Not provided at time of registration

Contact information

Prof Markus W Büchler
Scientific

University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)6221 56 6200
Email	markus.buechler@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DEPKR-Trial
Study objectives	To compare two different surgical techniques for the treatment of chronic pancreatitis with regard to complication rates, length of operation, length of intensive care treatment, length of hospital stay, exocrine/endocrine pancreatic function and quality of life.
Ethics approval(s)	Ethics approval received from the Independent Ethics Committee of the University of Heidelberg.
Health condition(s) or problem(s) studied	Chronic pancreatitis
Intervention	Every patient eligible for pancreatic head resection due to chronic pancreatitis will be asked for informed consent and will be thereafter intraoperatively randomised to either Beger's or the Berne modification of duodenum-preserving pancreatic head resection. A standardised surgical abdominal approach is performed in preparing the pancreatic head. The randomisation will proceed when the intraoperative decision for resection of the pancreatic head is made. The comparison of specific primary and secondary endpoints will assess the superiority of one technique. Patients will be followed up for 24 months.
Intervention type	Other
Primary outcome measure(s)	The primary endpoint is combined out of four components. In order to adjust for multiple testing a hierarchical model is used. 1. Duration of surgical procedure [min] 2. Quality of life (EORTC QLQ-C30 questionnaire and the disease specific module for pancreatic diseases EORTC QLQ-PAN26) at 12 months after the intervention 3. Duration of stay on the intensive care unit 4. Duration of postoperative hospital stay
Key secondary outcome measure(s)	Frequencies of early and late onset complications such as intra- or postoperative bleeding with subsequent need for blood transfusion, pancreatic fistula, postoperative pulmonary complications, wound infections and re-laparotomy; exocrine and endocrine pancreatic function as determined by levels of HbA1c and stool elastase.
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	65
Key inclusion criteria	Patients undergoing elective duodenum-preserving pancreatic head resection due to chronic pancreatitis. Eligibility criteria: 1. Patients of any age (greater than 18 years) 2. Expected survival time more than 24 months 3. Informed consent
Key exclusion criteria	1. Participation in another intervention trial that would interfere with the intervention and outcome of this study 2. Severe psychiatric disorders or neurological diseases 3. Lack of compliance 4. Drug and/or alcohol abuse according to local standards
Date of first enrolment	01/09/2003
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

Germany

Study participating centre

University of Heidelberg Medical School

Heidelberg
69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/04/2008		Yes	No
Protocol article	Protocol	08/05/2006		Yes	No