Condition category
Digestive System
Date applied
20/09/2005
Date assigned
21/10/2005
Last edited
08/09/2009
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 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

Sponsor information

Organisation

University of Leipzig (Germany)

Sponsor details

Liebigstrasse 20
Department of Surgery II
Leipzig
04103
Germany

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