Condition category
Digestive System
Date applied
27/05/2004
Date assigned
01/09/2004
Last edited
30/08/2011
Prospective/Retrospective
Retrospectively 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

Prof Markus W Büchler

ORCID ID

Contact details

University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6200
markus.buechler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KSC 06/2003

Study information

Scientific title

Acronym

DEPKR-Trial

Study hypothesis

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

Ethics approval received from the Independent Ethics Committee of the University of Heidelberg.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

01/09/2003

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant 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

Recruitment start date

01/09/2003

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University of Heidelberg Medical School
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg Medical School (Germany)

Sponsor details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6987
Markus_Buechler@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://med.uni-hd.de/index_eng.html

Funders

Funder type

University/education

Funder name

University of Heidelberg Medical School (Germany)

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

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16677402
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18374046

Publication citations

  1. Protocol

    Köninger J, Seiler CM, Wente MN, Reidel MA, Gazayakan E, Mansmann U, Müller MW, Friess H, Büchler MW, Duodenum preserving pancreatectomy in chronic pancreatitis: design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764]., Trials, 2006, 7, 12, doi: 10.1186/1745-6215-7-12.

  2. Results

    Köninger J, Seiler CM, Sauerland S, Wente MN, Reidel MA, Müller MW, Friess H, Büchler MW, Duodenum-preserving pancreatic head resection--a randomized controlled trial comparing the original Beger procedure with the Berne modification (ISRCTN No. 50638764)., Surgery, 2008, 143, 4, 490-498, doi: 10.1016/j.surg.2007.12.002.

Additional files

Editorial Notes