- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335151
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
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
-
-
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Zürich, Switzerland, 8063
- Stadtspital Triemli
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-
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
|
Apply desflurane as anesthetic
Other Names:
|
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
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neoplastic Processes
- Pancreatic Diseases
- Neoplasm Metastasis
- Adenocarcinoma
- Pancreatic Neoplasms
- Neoplastic Cells, Circulating
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Anesthetics, Inhalation
- Desflurane
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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