Distal Pancreatectomy: a randomised controlled trial to compare two different surgical techniques
| ISRCTN | ISRCTN18452029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18452029 |
| Protocol serial number | SDGC 01/2004 |
| Sponsor | University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) |
| Funder | University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) |
- 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
Scientific
Department of General, Visceral and Trauma Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0) 62 2156 6986 |
|---|---|
| markus.buechler@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| 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. |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The combined primary endpoint is the presence of a pancreatic fistula and/or death due to any cause on day seven post-operatively. |
| Key secondary outcome measure(s) |
1. Operating time |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 450 |
| 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
- United Kingdom
- Germany
- Italy
- Netherlands
- Slovenia
- Sweden
- Switzerland
Study participating centre
Department of General, Visceral and Trauma Surgery
Heidelberg
69120
Germany
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
