NCT02335151

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2016

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2.9 years

First QC Date

December 13, 2014

Last Update Submit

December 12, 2019

Conditions

AdenocarcinomaCirculating Tumor CellsPancreatic Neoplasms

Keywords

Circulating Tumor CellsAnesthesia and immunityCell Search System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Kinetics of CTC after surgery up to day 7

    1 year

  • Month to Tumor recurrence

    1 year

  • Number of surviving patients

    1 year

Study Arms (2)

Desflurane

EXPERIMENTAL

General anesthesia with Desflurane

Drug: Desflurane

Propofol

NO INTERVENTION

General anesthesia with Propofol

Interventions

DesfluraneDRUG

Apply desflurane as anesthetic

Also known as: Suprane
Desflurane

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85
  • ASA I-III ( American Society of Anesthesiologists)
  • Resectable pancreatic adenocarcinoma
  • Primary surgery
  • No neoadjuvant therapy
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

AdenocarcinomaNeoplastic Cells, CirculatingPancreatic Neoplasms

Interventions

Desflurane

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Beatrice Beck Schimmer, Prof. MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2014

First Posted

January 9, 2015

Study Start

October 1, 2016

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Data will not be shared

Locations

CH(4)