CTC Pancreatic Adenocarcinoma

Phase 4

Completed

• Conditions: Adenocarcinoma; Circulating Tumor Cells; Pancreatic Neoplasms
• Interventions: Drug: Desflurane

• Registration Number: NCT02335151
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-09
• Study Start: 2016-10
• Primary Completion: 2019-09
• Study Completion: 2019-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	Desflurane	General anesthesia with Desflurane

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (4)

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland