Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CTC Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02335151
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
Kantonsspital Winterthur KSW
Triemli Hospital
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Adenocarcinoma Circulating Tumor Cells Pancreatic Neoplasms Drug: Desflurane Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane

Arm Intervention/treatment
Experimental: Desflurane
General anesthesia with Desflurane
Drug: Desflurane
Apply desflurane as anesthetic
Other Name: Suprane

No Intervention: Propofol
General anesthesia with Propofol



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Kinetics of CTC after surgery up to day 7 [ Time Frame: 1 year ]
    CTC will be counted and kinetics of CTC will be determined.

  2. Month to Tumor recurrence [ Time Frame: 1 year ]
    Tumor recurrence will be monitored.

  3. Number of surviving patients [ Time Frame: 1 year ]
    One year after surgery the number of patients still being alive will be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02335151


Locations
Layout table for location information
Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
University Hospital Zurich
Zurich, Switzerland, 8091
Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
University of Zurich
Kantonsspital Winterthur KSW
Triemli Hospital
Cantonal Hospital of St. Gallen
Investigators
Layout table for investigator information
Principal Investigator: Beatrice Beck Schimmer, Prof. MD University of Zurich

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02335151    
Other Study ID Numbers: 2016 -00448
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared
Keywords provided by University of Zurich:
Circulating Tumor Cells
Anesthesia and immunity
Cell Search System
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplastic Cells, Circulating
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Anesthetics
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General