- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741167
Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
May 3, 2017 updated by: University of Zurich
The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.
Study Overview
Detailed Description
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies.
However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy.
Among complications infectious complications are the most common.
The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dilmurodjon Eshmuminov, MD
- Phone Number: +41 44 255 11 11
- Email: dilmurodjon.eshmuminov@usz.ch
Study Contact Backup
- Name: Kuno Lehmann, MD, PhD
- Phone Number: +41 44 255 23 04
- Email: kuno.lehmann@usz.ch
Study Locations
-
-
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Zurich, Switzerland, 8091
- Recruiting
- Division of Visceral Surgery and Transplantation , University Hospital Zurich
-
Contact:
- Dilmurodjon Eshmuminov, MD
- Phone Number: +41 44 255 11 11
- Email: dilmurodjon.eshmuminov@usz.ch
-
Contact:
- Kuno Lehmann, MD, PhD
- Phone Number: +41 44 255 23 04
- Email: kuno.lehmann@usz.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Consecutive adult patients (more than 18 years) subjected to cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) due to peritoneal malignancy at our institution.
Description
Inclusion Criteria:
- Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy.
- Written informed consent by the participant after information about the research project
Exclusion Criteria:
- No primary or secondary peritoneal surface malignancy
- No CRS and HIPEC
- Pregnancy
- Younger than 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CRS and HIPEC
Patients subjected to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) due to primary or secondary peritoneal malignancy
|
During CRS, all visible peritoneal tumors are removed.
Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kuno Lehmann, Md. PhD, Dr. Kuno Lehmann, Division of Visceral Surgery and Transplantation, University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chua TC, Yan TD, Saxena A, Morris DL. Should the treatment of peritoneal carcinomatosis by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy still be regarded as a highly morbid procedure?: a systematic review of morbidity and mortality. Ann Surg. 2009 Jun;249(6):900-7. doi: 10.1097/SLA.0b013e3181a45d86.
- Votanopoulos K, Ihemelandu C, Shen P, Stewart J, Russell G, Levine EA. A comparison of hematologic toxicity profiles after heated intraperitoneal chemotherapy with oxaliplatin and mitomycin C. J Surg Res. 2013 Jan;179(1):e133-9. doi: 10.1016/j.jss.2012.01.015. Epub 2012 Mar 10.
- Roviello F, Caruso S, Marrelli D, Pedrazzani C, Neri A, De Stefano A, Pinto E. Treatment of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: state of the art and future developments. Surg Oncol. 2011 Mar;20(1):e38-54. doi: 10.1016/j.suronc.2010.09.002. Epub 2010 Dec 15.
- Klein HJ, Csordas A, Falk V, Slankamenac K, Rudiger A, Schonrath F, Rodriguez Cetina Biefer H, Starck CT, Graf R. Pancreatic stone protein predicts postoperative infection in cardiac surgery patients irrespective of cardiopulmonary bypass or surgical technique. PLoS One. 2015 Mar 20;10(3):e0120276. doi: 10.1371/journal.pone.0120276. eCollection 2015.
- Younan R, Kusamura S, Baratti D, Cloutier AS, Deraco M. Morbidity, toxicity, and mortality classification systems in the local regional treatment of peritoneal surface malignancy. J Surg Oncol. 2008 Sep 15;98(4):253-7. doi: 10.1002/jso.21057.
- Sonnenberg EM, Reinke CE, Bartlett EK, Collier KT, Karakousis GC, Holena DN, Kelz RR. Wind, water, wound, walk--do the data deliver the dictum? J Surg Educ. 2015 Jan-Feb;72(1):164-9. doi: 10.1016/j.jsurg.2014.05.019. Epub 2014 Aug 12.
- Lehmann K, Eshmuminov D, Slankamenac K, Kranzbuhler B, Clavien PA, Vonlanthen R, Gertsch P. Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC. World J Surg. 2016 May;40(5):1075-81. doi: 10.1007/s00268-015-3366-0.
- Capone A, Valle M, Proietti F, Federici O, Garofalo A, Petrosillo N. Postoperative infections in cytoreductive surgery with hyperthermic intraperitoneal intraoperative chemotherapy for peritoneal carcinomatosis. J Surg Oncol. 2007 Nov 1;96(6):507-13. doi: 10.1002/jso.20837.
- Roth L, Eshmuminov D, Laminger F, Koppitsch C, Schneider M, Graf TR, Gupta A, Kober F, Roka S, Gertsch P, Lehmann K. Systemic inflammatory response after hyperthermic intraperitoneal chemotherapy (HIPEC): The perfusion protocol matters! Eur J Surg Oncol. 2019 Sep;45(9):1734-1739. doi: 10.1016/j.ejso.2019.03.036. Epub 2019 Mar 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
March 30, 2016
First Submitted That Met QC Criteria
April 12, 2016
First Posted (Estimate)
April 18, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2017
Last Update Submitted That Met QC Criteria
May 3, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIPEC 2015-0529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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