Condition category
Cancer
Date applied
12/09/2005
Date assigned
17/02/2006
Last edited
23/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19309495

Publication citations

  1. 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.

Additional files

Editorial Notes