Contact information
Type
Scientific
Primary contact
Prof Markus W. Büchler
ORCID ID
Contact details
Department of General
Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0) 62 2156 6986
markus.buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SDGC 01/2004
Study information
Scientific title
Acronym
DISPACT-Trial
Study hypothesis
The trial is designed to show that the risk of developing a pancreatic fistula and/or death until day seven after the surgical procedure can be reduced by stapler-closure of the pancreatic remnant compared to scalpel transsection and hand-sewn suture following distal pancreatectomy.
Ethics approval
Ethics approval received from the Ethikkommission der Medizinischen Fakultät Heidelberg on the 10th August 2006 (1st vote), 28th August 2006 (final vote), 4th October 2006 (Amendment I), 26th January 2007 (Amendment II) (ref: 245/2006).
Study design
A multi-centre (20 international centres), pre-operatively randomised, controlled and patient and observer blinded trial performed as a parallel group adaptive superiority design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diseases of the pancreatic body and tail
Intervention
Distal pancreatectomy:
1. Experimental group: stapler resection
2. Control group: scalpel resection and hand-suture of the pancreatic stump
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The combined primary endpoint is the presence of a pancreatic fistula and/or death due to any cause on day seven post-operatively.
Secondary outcome measures
1. Operating time
2. Frequencies of burst abdomen, wound infection, and intra-abdominal fluid collection and abscess
3. Post-operative length of hospital stay
4. New onset of diabetes mellitus
5. One-year survival
Overall trial start date
01/12/2006
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age equal or above 18 years
2. Expected survival time more than 12 months
3. Patients with at least one of the following pathologic diseases scheduled for elective resection:
3.1. Resectable malignancies of the pancreatic body and/or tail
3.2. Resectable chronic pancreatitis of the body and/or tail
3.3. Resectable benign tumours of the pancreas including neuroendocrine tumours
3.4. Resectable pseudocyst of the pancreatic body and/or tail
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of approximately 450 patients will be randomised
Participant exclusion criteria
1. Current immunosuppressive therapy
2. Chemotherapy within two weeks before operation
3. Radiotherapy within eight weeks before operation
4. Curative resection is not feasible
5. Severe psychiatric or neurologic diseases
6. Drug and/or alcohol abuse according to local standards
7. Participation in another intervention trial with interference of intervention or outcome
8. Inability to follow the instructions given by the investigator or interviewer
9. Expected lack of compliance
10. Lack of informed consent
Recruitment start date
01/12/2006
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany, Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom
Trial participating centre
Department of General, Visceral and Trauma Surgery
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Sponsor details
Study Centre of the German Surgical Society (SDGC)
Department of General
Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)62 2156 6986
sdgc@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19630998
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21529927
Publication citations
-
Results
Bruns H, Rahbari NN, Löffler T, Diener MK, Seiler CM, Glanemann M, Butturini G, Schuhmacher C, Rossion I, Büchler MW, Junghans T, , Perioperative management in distal pancreatectomy: results of a survey in 23 European participating centres of the DISPACT trial and a review of literature., Trials, 2009, 10, 58, doi: 10.1186/1745-6215-10-58.
-
Results
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Büchler MW, Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial., Lancet, 2011, 377, 9776, 1514-1522, doi: 10.1016/S0140-6736(11)60237-7.