CTC Pancreatic Adenocarcinoma

December 12, 2019 updated by: University of Zurich

Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?

Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur
      • Zurich, Switzerland, 8091
        • University Hospital Zurich
      • Zürich, Switzerland, 8063
        • Stadtspital Triemli

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 85
  • ASA I-III ( American Society of Anesthesiologists)
  • Resectable pancreatic adenocarcinoma
  • Primary surgery
  • No neoadjuvant therapy
  • Written informed consent

Exclusion Criteria:

  • Metastatic disease
  • Other than primary surgery (recurrence, reconstruction)
  • Pre-operative chemotherapy
  • Chronic opioid use
  • Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
  • Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
  • Pregnancy
  • Breast feeding
  • Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane
General anesthesia with Desflurane
Drug: Desflurane
Apply desflurane as anesthetic
Other Names:
  • Suprane
No Intervention: Propofol
General anesthesia with Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak of CTC in the postoperative phase after curative tumor removal
Time Frame: Day 0 to Day 7
CTC will be counted and peak of CTC will be determined.
Day 0 to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinetics of CTC after surgery up to day 7
Time Frame: 1 year
CTC will be counted and kinetics of CTC will be determined.
1 year
Month to Tumor recurrence
Time Frame: 1 year
Tumor recurrence will be monitored.
1 year
Number of surviving patients
Time Frame: 1 year
One year after surgery the number of patients still being alive will be determined.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Cantonal Hospital of St. Gallen
Triemli Hospital
Kantonsspital Winterthur KSW

Investigators

  • Principal Investigator: Beatrice Beck Schimmer, Prof. MD, University of Zurich

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 (Actual)

October 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 13, 2014

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016 -00448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared

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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