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CTC Pancreatic Adenocarcinoma

Primary Purpose

Adenocarcinoma, Circulating Tumor Cells, Pancreatic Neoplasms

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Desflurane
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring Circulating Tumor Cells, Anesthesia and immunity, Cell Search System

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kantonsspital St. Gallen
  • Kantonsspital Winterthur
  • University Hospital Zurich
  • Stadtspital Triemli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Desflurane

Propofol

Arm Description

General anesthesia with Desflurane

General anesthesia with Propofol

Outcomes

Primary Outcome Measures

Peak of CTC in the postoperative phase after curative tumor removal
CTC will be counted and peak of CTC will be determined.

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2014
Last Updated
December 12, 2019
Sponsor
University of Zurich
Collaborators
Kantonsspital Winterthur KSW, Triemli Hospital, Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT02335151
Brief Title
CTC Pancreatic Adenocarcinoma
Official Title
Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Kantonsspital Winterthur KSW, Triemli Hospital, Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Circulating Tumor Cells, Pancreatic Neoplasms
Keywords
Circulating Tumor Cells, Anesthesia and immunity, Cell Search System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desflurane
Arm Type
Experimental
Arm Description
General anesthesia with Desflurane
Arm Title
Propofol
Arm Type
No Intervention
Arm Description
General anesthesia with Propofol
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Suprane
Intervention Description
Apply desflurane as anesthetic
Primary Outcome Measure Information:
Title
Peak of CTC in the postoperative phase after curative tumor removal
Description
CTC will be counted and peak of CTC will be determined.
Time Frame
Day 0 to Day 7
Secondary Outcome Measure Information:
Title
Kinetics of CTC after surgery up to day 7
Description
CTC will be counted and kinetics of CTC will be determined.
Time Frame
1 year
Title
Month to Tumor recurrence
Description
Tumor recurrence will be monitored.
Time Frame
1 year
Title
Number of surviving patients
Description
One year after surgery the number of patients still being alive will be determined.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Beck Schimmer, Prof. MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Stadtspital Triemli
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared

Learn more about this trial

CTC Pancreatic Adenocarcinoma

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