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
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Chris Braumann
Scientific

Schumannstrasse 20/21
Berlin
10117
Germany

Phone	+49 (0)30450622156
Email	chris.braumann@charite.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Taurolidine, Povidone-iodine
Primary outcome measure	Interleukin-1 beta perioperatively measured six times
Secondary outcome measures	1. Evaluation of morbidity and mortality 2. Side-effects 3. Long-term follow-up after 3, 6, 12 months and 2, 3, 4 and 5 years
Overall study start date	01/01/1999
Completion date	30/04/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Schumannstrasse 20/21

Berlin
10117
Germany

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

Department of Surgery
Schumannstrasse 20/21
Berlin
10117
Germany

Other

Insurance funding (Gerling Versicherungs-Service AG) (Germany)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/03/2009		Yes	No