Prospective, randomised, single-blind study for validation of the effect of endoscopic stent implantation and drainage on patients with chronic pancreatitis and pancreas duct stenosis

ISRCTN	ISRCTN13044540
DOI	https://doi.org/10.1186/ISRCTN13044540
Secondary identifying numbers	N/A

Submission date: 20/09/2005
Registration date: 21/10/2005
Last edited: 08/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Volker Keim
Scientific

Liebigstrasse 20
Medical Clinic for Gastroenterology and Rheumatology (Medizinische Klinik für Gastroenterologie und Rheumatologie)
University Hospital Leipzig (Universitätsklinikum Leipzig AöR)
Leipzig
04103
Germany

Phone	+49 (0)3419712233
Email	keimv@medizin.uni-leipzig.de

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	PAGASTE
Study objectives	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(s)	Added 08/09/09: Received from Leipzig Medical Faculty ethics committee, University of Leipzig on the 14th of April 2004
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2004
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/05/2004
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany

Study participating centre

Liebigstrasse 20

Leipzig
04103
Germany

Sponsor information

University of Leipzig (Germany)
University/education

Liebigstrasse 20
Department of Surgery II
Leipzig
04103
Germany

"ROR"	https://ror.org/03s7gtk40

Funders

Funder type

University/education

University of Leipzig (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan