CTC Pancreatic Adenocarcinoma

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02335151

Collaborator

Kantonsspital Winterthur KSW (Other), Triemli Hospital (Other), Cantonal Hospital of St. Gallen (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

21.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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)

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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 2016

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Peak of CTC in the postoperative phase after curative tumor removal [Day 0 to Day 7]
CTC will be counted and peak of CTC will be determined.

Secondary Outcome Measures

Kinetics of CTC after surgery up to day 7 [1 year]
CTC will be counted and kinetics of CTC will be determined.
Month to Tumor recurrence [1 year]
Tumor recurrence will be monitored.
Number of surviving patients [1 year]
One year after surgery the number of patients still being alive will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kantonsspital St. Gallen	St. Gallen	Switzerland	9007
2	Kantonsspital Winterthur	Winterthur	Switzerland	8401
3	University Hospital Zurich	Zurich	Switzerland	8091
4	Stadtspital Triemli	Zürich	Switzerland	8063