Clinical trial NCT02741167: Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Official title: Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Cancer
Keywords: peritoneal surface malignancies
cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Visceral Surgery and Transplantation , University Hospital Zurich
Study officials:
affiliation: Dr. Kuno Lehmann, Division of Visceral Surgery and Transplantation, University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland
name: Kuno Lehmann, Md. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.