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CTC Pancreatic Adenocarcinoma

NCT ID: NCT02335151

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-10-31

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.

Conditions

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Adenocarcinoma Circulating Tumor Cells Pancreatic Neoplasms

Keywords

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Circulating Tumor Cells Anesthesia and immunity Cell Search System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Desflurane

General anesthesia with Desflurane

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Apply desflurane as anesthetic

Propofol

General anesthesia with Propofol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Desflurane

Apply desflurane as anesthetic

Intervention Type DRUG

Other Intervention Names

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Suprane

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

Triemli Hospital

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatrice Beck Schimmer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status

Stadtspital Triemli

Zurich, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016 -00448

Identifier Type: -

Identifier Source: org_study_id