CTC Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?

Conditions
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Adenocarcinoma, Circulating Tumor Cells, Pancreatic Neoplasms

Intervention / Treatment
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* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desflurane<br>General anesthesia with Desflurane | Drug: Desflurane<br>* Apply desflurane as anesthetic<br>* Other names: Suprane;|
| No Intervention: Propofol<br>General anesthesia with Propofol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak of CTC in the postoperative phase after curative tumor removal | 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 | CTC will be counted and kinetics of CTC will be determined. | 1 year | 
| Month to Tumor recurrence | Tumor recurrence will be monitored. | 1 year | 
| Number of surviving patients | One year after surgery the number of patients still being alive will be determined. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Tumor Cells, Anesthesia and immunity, Cell Search System