Trial document
DRKS00000005
Trial Description
Title
DISPACT: Distal Pancreatectomy - A randomized controlled trial to compare two different surgical techniques
Trial Acronym
DISPACT-Trial
URL of the Trial
Brief Summary in Lay Language
The aim of the trial is to evaluate, which surgical technique is the best to reduce postoperative pancreatic fistula rate. Therefore two surgical techniques are compared to each other. Both techniques share the same goal: to remove the diseased tissue, the pancreatic tail. This resection can be performed either with the scalpel or with the stapler. Using the stapler, the remaining part of the pancreas will be closed with a stapler line, while the resection with the scalpel is followed by the manual suture of the remaining part of the pancreas. Both techniques are standards, that are used in many hospital to the same extend. But until today there is no evidence of the superiority of one techniques towards the other regarding the incidence of postoperative pancreatic fistula.
Brief Summary in Scientific Language
This is a multi-center, pre-operatively randomized, controlled and patient and observer blinded trial performed as a parallel group adaptive superiority design. The randomization is done stratified for centers and risk level (low/high). The patient is blinded for the technique used in order to prevent an impact on secondary endpoints.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00000005
- 2008/08/08
- 2006/07/18
- yes
- Approved
- 245/2006, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- 18452029 (ISRCTN Register)
- UKF001249 (Register Klinischer Studien des Universitätsklinikums Freiburg)
- DISPACT-Trial
Health Condition or Problem studied
- C25 - Malignant neoplasm of pancreas
- K86.3 - Pseudocyst of pancreas
- K86.1 - Other chronic pancreatitis
- 5-524: null
Interventions/Observational Groups
- Control group: Scalpel resectioning and manual closing of suture
- Experimental group: Resectioning and closing with stapler
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control
- Treatment
- Parallel
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Primary Outcome
Combined primary endpoint: presence of a pancreatic fistula and / or death due to any cause on day 7 postoperatively.
Secondary Outcome
Secondary endpoints: operating time, frequency of burst abdomen, wound infection, and intraabdominal fluid collection and abscess, postoperative length of hospital stay, new onset of diabetes mellitus, one-year survival.
Countries of Recruitment
- Belgium
- Italy
- Netherlands
- Slovenia
- United Kingdom
- Germany
Locations of Recruitment
- [---]*
Recruitment
- Actual
- 2007/01/01
- 450
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
-Age equal or above 18 years
-Expected survival time more than 12 month
-Patients with at least one of the following pathologic diseases scheduled for elective resection:
*Resectable malignancies of pancreatic body and/or tail
*Resectable chronic pancreatitis of the body and/or tail
*Resectable benigne tumours of the pancreas including neuroendocrine tumours
*Resectable pseudocyst of the pancreatic body and/or tail
Exclusion Criteria
-Current immunosuppressive therapy
-Chemotherapy within 2 weeks before operation
-Radiotherapy within 8 weeks before operation
-Curative resecion is not feasible
-Severe psychiatric or neurologic diseases
-Drug- and/or alcohol-abuse according to local standarts
-Participation in another intervention trial with interference of intervention or outcome
-Inability to follow instructions given by the investigator or interviewer
-Expected lack of compliance
-Lack of informed consent
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- sdgc at med.uni-heidelberg.de
- http://www.sdgc.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg
- Mr. Dr. med. Markus Diener
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 56 6986
- +49 56 6988
- markus.diener at med.uni-heidelberg.de
- http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.83.0.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg
- Ms. Inga Rossion
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 6221 56-6984
- +49 6221 56-6984
- inga.rossion at med.uni-heidelberg.de
- http://www.sdgc.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung DLR Projektträger Gesundheitsforschung
- Heinrich-Konen-Str. 1
- 53227 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.bmbf.de/index.php
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2009/07/03
Trial Publications, Results and other Documents
-
DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy - study rationale and design.
MK Diener, HP Knaebel, ST Witte, I. Rossion, M. Kieser, MW Buchler, CM Seiler and the DISPACT Trial Group.
http://ctj.sagepub.com Clinical Trials DOI: 10.1177/ 1740774508096140 Clin Trials 2008; 5; 534 - Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial