Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000257369
Ethics application status
Approved
Date submitted
17/04/2008
Date registered
20/05/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term outcome after endoscopic treatment of necrosis due to pancreatitis.
Scientific title
Transluminal Endoscopic Necrosectomy
after Acute Pancreatitis: a Multicenter Study with Long-Term Follow-up (the GEPARD Study). Evaluation of peri- and post-procedural mortality and morbidity as well as long-term follow-up evaluation of survival, indication to surgery and quality of life.
Universal Trial Number (UTN)
Trial acronym
GEPARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infected retroperitoneal necrosis 3068 0
acute necrotizing pancreatitis 3069 0
Condition category
Condition code
Oral and Gastrointestinal 3223 3223 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transluminal endoscopic necrosectomy: 1)transgastric or transduodenal access to the retroperitoneal cavity using endoscopic or endosonographic guidance. 2)balloon dilation of the access was carried out to permit the introduction of a conventional gastroscope to allow forceful irrigation and suction, as well as active endoscopic removal of debris using snares, forceps, and stone removal baskets. 3)Repeated sessions at intervals of 1–4 days were carried out until all debris and necrotic material had been removed and the walls of the collections could be seen as vital structures. The duration of a session was determined mainly by patient tolerance of sedation or general anesthesia, but was usually limited to 90 minutes.
Intervention code [1] 2811 0
Other interventions
Comparator / control treatment
no control, description of outcome of treatment only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4105 0
all cause mortality.
Timepoint [1] 4105 0
at two to eight years after end of enrollment
Primary outcome [2] 4106 0
incidence of pancreatic complications
Timepoint [2] 4106 0
at two to eight years after end of enrollment
Secondary outcome [1] 6920 0
quality of life was measured using a simplyfied pancreatitis centered QOL questionare.
Timepoint [1] 6920 0
at two to eight years after end of enrollment

Eligibility
Key inclusion criteria
infected peripancreatic / retroperitoneal necrosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gastric varices

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 923 0
Germany
State/province [1] 923 0

Funding & Sponsors
Funding source category [1] 3315 0
Hospital
Name [1] 3315 0
Charite - Medizinische Klinik m.S. Gastroenterologie
Country [1] 3315 0
Germany
Primary sponsor type
Hospital
Name
Charite - Medizinische Klinik m.S. Gastroenterologie
Address
- Mittelallee 11 -
Augustenburger Platz 1
13353 Berlin
Country
Germany
Secondary sponsor category [1] 2966 0
None
Name [1] 2966 0
Address [1] 2966 0
Country [1] 2966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5300 0
Ethikkommission der Charite
Ethics committee address [1] 5300 0
Chariteplatz 1
10117 Berlin
Ethics committee country [1] 5300 0
Germany
Date submitted for ethics approval [1] 5300 0
27/03/2008
Approval date [1] 5300 0
31/03/2008
Ethics approval number [1] 5300 0
EA2/040/08

Summary
Brief summary
infected necrosis after acute necrotizing pancreatitis was treated with a transluminal endoscopic approach. the long term clinical outcome was evaluated retrospectively over a follow-up of 2 to 8 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28540 0
Address 28540 0
Country 28540 0
Phone 28540 0
Fax 28540 0
Email 28540 0
Contact person for public queries
Name 11697 0
Michael Biermer
Address 11697 0
Medizinische Klinik m.S. Gastroenterologie
-Mittelallee 11-
Augustenburger Platz
13353 Berlin
Country 11697 0
Germany
Phone 11697 0
+4930450553072
Fax 11697 0
Email 11697 0
[email protected]
Contact person for scientific queries
Name 2625 0
Michael Biermer
Address 2625 0
Medizinische Klinik m.S. Gastroenterologie
-Mittelallee 11-
Augustenburger Platz
13353 Berlin
Country 2625 0
Germany
Phone 2625 0
+4930450553072
Fax 2625 0
Email 2625 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.