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

Status

Unknown

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Division of Visceral Surgery and Transplantation , University Hospital Zurich
        • Contact:
        • Contact:

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
Procedure: CRS and HIPEC
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

University of Zurich

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

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.

Clinical Trials on Peritoneal Cancer

Clinical Trials on CRS and HIPEC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe