Intra-operative administration of taurolidine reduces level of interleukin-1 beta rather than povidone-iodine in patients with colon, gastric, and pancreatic cancer. A clinical prospective randomised multicenter trial.
| ISRCTN | ISRCTN66478538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66478538 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | Insurance funding (Gerling Versicherungs-Service AG) (Germany) |
- Submission date
- 12/09/2005
- Registration date
- 17/02/2006
- Last edited
- 23/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chris Braumann
Scientific
Scientific
Schumannstrasse 20/21
Berlin
10117
Germany
| Phone | +49 (0)30450622156 |
|---|---|
| chris.braumann@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | IPATI |
| Study objectives | Taurolidine suppresses the intraperitoneal levels of cytokines and might influence tumor growth |
| Ethics approval(s) | The Ethics Committee of the Charite Campus Mitte, University Hospital, (Universitaetsmedizin) Berlin, Germany, as the leading study center, approved the study design in 1998. The study was carried out in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients before enrolment. |
| Health condition(s) or problem(s) studied | Colon, gastric or pancreatic cancer |
| Intervention | 120 Patients with colon, gastric or pancreatic cancer have been randomised between January 1999 and August 2001 to receive either taurolidine or povidone-iodine intraperitoneally during open resection. Intra-operative instillation of 0.5% taurolidine versus 0.25% povidone-iodine solution. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Taurolidine, Povidone-iodine |
| Primary outcome measure(s) |
Interleukin-1 beta perioperatively measured six times |
| Key secondary outcome measure(s) |
1. Evaluation of morbidity and mortality |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Open resection of colon, gastric, or pancreatic cancer 2. American Society of Anesthesiologists (ASA) I-III classification 3. Histopathological R0-resection |
| Key exclusion criteria | 1. Complete ileus 2. ASA IV classification 3. Histopathological R1- or R2-resection 4. Unknown intra-operative metastasis, peritoneal carcinomatosis, intra-abdominal abscess, sepsis or clinically relevant organ failure 5. Apparent coagulopathy |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Schumannstrasse 20/21
Berlin
10117
Germany
10117
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 | 23/03/2009 | Yes | No |
