Contact information
Type
Scientific
Primary contact
Prof Volker Keim
ORCID ID
Contact details
Liebigstrasse 20
Medical Clinic for Gastroenterology and Rheumatology (Medizinische Klinik für Gastroenterologie und Rheumatologie)
University Hospital Leipzig (Universitätsklinikum Leipzig AöR)
Leipzig
04103
Germany
+49 (0)3419712233
keimv@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PAGASTE
Study hypothesis
The background is the already aged obstruction hypothesis. It is assumed that a relevant stricture of the pancreatic duct leads to retention and stasis of the pancreatic juice thereby mitigating pain and inflammation. If the stent achieves a drainage the frequency of episodes of pain and inflammation should be significantly reduced.
Please note that as of 08/09/09 the contact address and ethics approval have been updated. Please also note that the end date of this trial has been extended from 01/04/07 to 31/12/2010.
Ethics approval
Added 08/09/09: Received from Leipzig Medical Faculty ethics committee, University of Leipzig on the 14th of April 2004
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 with pancreatic duct stenosis
Intervention
Endoscopic stenting of the pancreatic duct, stent exchange after 3 months versus conservative treatment with analgesics
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Total pain score during first 3 month after ERCP, specialised Pancreas Pain Questionaire checked for reliability and validity
Secondary outcome measures
1. Use af analgesics
2. Frequency of pain episodes within one year
3. Treatment failure
4. Signs of endocrine/exocrine failure
5. Change of diameter of pancreatic duct during treatment
Overall trial start date
01/05/2004
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronic pancreatitis with evidence of magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)
pancreatic duct stricture (>50%) in pancreatic head
2. Chronic recurrent pain
3. Age >18, <75, WIC
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Radiation of upper abdominal or lower chest area
2. Uncured cancer or systemic chemotherapy within last 5 years
3. Failure of compliance
4. Foreseeable
pregnancy
5. Participation in other therapeutic trials within last 30 days
6. Patients continuous free of symptoms
Recruitment start date
01/05/2004
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Liebigstrasse 20
Leipzig
04103
Germany
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