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Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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ClinicalTrials.gov Identifier: NCT02741167
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment
Peritoneal Cancer Procedure: CRS and HIPEC

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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
Procedure: CRS and HIPEC
During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy




Primary Outcome Measures :
  1. C reactive protein (CRP) mg/l, receiver operating characteristic (ROC) [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741167


Contacts
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Contact: Kuno Lehmann, MD, PhD +41 44 255 23 04 kuno.lehmann@usz.ch
Contact: Dilmurodjon Eshmuminov, MD +41 44 255 11 11 dilmurodjon.eshmuminov@usz.ch

Locations
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Switzerland
Division of Visceral Surgery and Transplantation , University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Kuno Lehmann, MD, PhD    +41 44 255 23 04    kuno.lehmann@usz.ch   
Contact: Dilmurodjon Eshmuminov, MD    +41 44 255 11 11    dilmurodjon.eshmuminov@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Kuno Lehmann, Md. PhD Dr. Kuno Lehmann, Division of Visceral Surgery and Transplantation, University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02741167     History of Changes
Other Study ID Numbers: HIPEC 2015-0529
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Zurich:
peritoneal surface malignancies
cytoreductive surgery
hyperthermic intraperitoneal chemotherapy

Additional relevant MeSH terms:
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Inflammation
Fever
Pathologic Processes
Body Temperature Changes
Signs and Symptoms