Condition category
Digestive System
Date applied
22/09/2005
Date assigned
21/11/2005
Last edited
21/09/2007
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 Helmut Witzigmann

ORCID ID

Contact details

Department of Surgery
Clinic II
Liebigstr. 20
Leipzig
04103
Germany
+49 (0)341/9717221
with@medizin.uni-leipzig.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Frey-Berner

Study hypothesis

Both surgical procedures are accepted as treatment for patients with chronic pancreatitis and chronic pain. They are both pancreatic tissue preserving in comparison to classic Whipple-procedure. The procedure after Berner is the shorter and less invasive surgical procedure with less resection of pancreatic tissue. Assuming an equal outcome in patients with chronic pancreatitis, the modification of Berner could be the gold standard as the least invasive and tissue resecting procedure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic pancreatitis

Intervention

Two surgical procedures in comparison - duodenum-preserving pancreatic head resection after Berner and after Frey.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of life

Secondary outcome measures

1. Local complications
2. Mortality
3. Morbidity
4. Exocrine and endocrine pancreatic function

Overall trial start date

01/03/2005

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic pancreatitis
2. Chronic pain greater than 1 year
3. Complications of chronic pancreatitis as duodenal stenosis or treatment resistent pancreatic duct stenosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66 patients - 33/group

Participant exclusion criteria

1. Chronic pancreatitis without involvement of pancretic head
2. Hints for malignant pancreas disorders
3. Not cured cancer or chemotherapy or radiation within last 5 years

Recruitment start date

01/03/2005

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Surgery, Clinic II
Leipzig
04103
Germany

Sponsor information

Organisation

University of Leipzig (Germany)

Sponsor details

Liebigstraße 20
Department of Surgery II
Leipzig
04103
Germany
+49 (0)341/9717221
with@medizin.uni-leipzig.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Leipzig (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

Publication citations

Additional files

Editorial Notes