Distal Pancreatectomy: a randomised controlled trial to compare two different surgical techniques

ISRCTN	ISRCTN18452029
DOI	https://doi.org/10.1186/ISRCTN18452029
Secondary identifying numbers	SDGC 01/2004

Submission date: 18/07/2006
Registration date: 26/07/2006
Last edited: 02/06/2011

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Markus W. Büchler
Scientific

Department of General, Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0) 62 2156 6986
Email	markus.buechler@med.uni-heidelberg.de

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	DISPACT-Trial
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2006
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	A total of approximately 450 patients will be randomised
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany
Italy
Netherlands
Slovenia
Sweden
Switzerland
United Kingdom

Study participating centre

Department of General, Visceral and Trauma Surgery

Heidelberg
69120
Germany

Sponsor information

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
University/education

Study Centre of the German Surgical Society (SDGC)
Department of General, Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)62 2156 6986
Email	sdgc@med.uni-heidelberg.de
Website	http://www.sdgc.de
"ROR"	https://ror.org/013czdx64

Funders

Funder type

Hospital/treatment centre

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/07/2009		Yes	No
Results article	results	30/04/2011		Yes	No