Clinical Trial Record

Return to Clinical Trials

CTC Pancreatic Adenocarcinoma


2016-10


2019-09


2019-10


86

Study Overview

CTC Pancreatic Adenocarcinoma

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)

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.

  • Adenocarcinoma
  • Circulating Tumor Cells
  • Pancreatic Neoplasms
  • DRUG: Desflurane
  • 2016 -00448

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 Registration Dates Results Reporting Dates Study Record Updates

2014-12-13  

N/A  

2019-12-12  

2015-01-08  

N/A  

2019-12-13  

2015-01-09  

N/A  

2019-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
Double


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Desflurane

General anesthesia with Desflurane

DRUG: Desflurane

  • Apply desflurane as anesthetic
NO_INTERVENTION: Propofol

General anesthesia with Propofol

Primary Outcome MeasuresMeasure DescriptionTime Frame
Peak of CTC in the postoperative phase after curative tumor removalCTC will be counted and peak of CTC will be determined.Day 0 to Day 7
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Kinetics of CTC after surgery up to day 7CTC will be counted and kinetics of CTC will be determined.1 year
Month to Tumor recurrenceTumor recurrence will be monitored.1 year
Number of surviving patientsOne year after surgery the number of patients still being alive will be determined.1 year

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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

  • Kantonsspital Winterthur KSW
  • Triemli Hospital
  • Cantonal Hospital of St. Gallen

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available