CTC Pancreatic Adenocarcinoma

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335151
• Other study ID #: 2016 -00448
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: October 2019

Study information

• Verified date: December 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Circulating Tumor Cells
• Neoplastic Cells, Circulating
• Pancreatic Neoplasms

Intervention

Drug:
• Desflurane
Apply desflurane as anesthetic

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	University Hospital Zurich	Zurich
Switzerland	Stadtspital Triemli	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Cantonal Hospital of St. Gallen, Kantonsspital Winterthur KSW, Triemli Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinetics of CTC after surgery up to day 7	CTC will be counted and kinetics of CTC will be determined.	1 year
Secondary	Month to Tumor recurrence	Tumor recurrence will be monitored.	1 year
Secondary	Number of surviving patients	One year after surgery the number of patients still being alive will be determined.	1 year