Contact information
Type
Scientific
Primary contact
Dr Chris Braumann
ORCID ID
Contact details
Schumannstrasse 20/21
Berlin
10117
Germany
+49 (0)30450622156
chris.braumann@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
IPATI
Study hypothesis
Taurolidine suppresses the intraperitoneal levels of cytokines and might influence tumor growth
Ethics approval
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
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 trial start date
01/01/1999
Overall trial end date
30/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Open resection of colon, gastric, or pancreatic cancer
2. American Society of Anesthesiologists (ASA) I-III classification
3. Histopathological R0-resection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/01/1999
Recruitment end date
30/04/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Schumannstrasse 20/21
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Department of Surgery
Schumannstrasse 20/21
Berlin
10117
Germany
+49 (0)30450522102
christoph.jacobi@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Insurance funding (Gerling Versicherungs-Service AG) (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/19309495
Publication citations
-
Results
Braumann C, Gutt CN, Scheele J, Menenakos C, Willems W, Mueller JM, Jacobi CA, Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial., World J Surg Oncol, 2009, 7, 32, doi: 10.1186/1477-7819-7-32.