AdenocarcinomaPhase 4NCT02335151
CTC Pancreatic Adenocarcinoma
A Phase 4 study testing Desflurane in people with Adenocarcinoma and Circulating Tumor Cells, run by University of Zurich at 4 sites in Switzerland.
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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenocarcinoma, Circulating Tumor Cells, Pancreatic Neoplasms
- What is being tested?
- Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Oct 2016to Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85
- ASA I-III ( American Society of Anesthesiologists)
- Resectable pancreatic adenocarcinoma
- Primary surgery
- No neoadjuvant therapy
- Written informed consent
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Kantonsspital St. Gallen
Sankt Gallen, 9007
Kantonsspital Winterthur
Winterthur, 8401
Stadtspital Triemli
Zurich, 8063
University Hospital Zurich
Zurich, 8091
About this study
Official title: Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
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)
Read the 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.
- Being tested
- Desflurane
- Keywords
- Circulating Tumor Cells, Anesthesia and immunity, Cell Search System
- Medical subject headings
- Adenocarcinoma, Neoplastic Cells, Circulating, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called Suprane
Apply desflurane as anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | General anesthesia with Desflurane Receives: Drug: Desflurane |
| Propofol | No intervention | General anesthesia with Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak of CTC in the postoperative phase after curative tumor removal
CTC will be counted and peak of CTC will be determined.
Measured: Day 0 to Day 7
Secondary outcomes (3)
Kinetics of CTC after surgery up to day 7
CTC will be counted and kinetics of CTC will be determined.
Measured: 1 year
Month to Tumor recurrence
Tumor recurrence will be monitored.
Measured: 1 year
Number of surviving patients
One year after surgery the number of patients still being alive will be determined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startOct 2016
- Primary completionSep 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Triemli Hospital, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Beatrice Beck Schimmer, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335151
- Sponsor's protocol ID
- 2016 -00448
- Other IDs
- 2016
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2014
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
- ClinicalTrials.gov ID
- NCT02335151
- Acronym / sponsor ID
- 2016 -00448
- Keywords
- Circulating Tumor Cells, Anesthesia and immunity, Cell Search System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Triemli Hospital, Cantonal Hospital of St. Gallen
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: DesfluraneGeneral anesthesia with Desflurane |
| Propofol | No intervention | –General anesthesia with Propofol |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 85
- ASA I-III ( American Society of Anesthesiologists)
- Resectable pancreatic adenocarcinoma
- Primary surgery
- No neoadjuvant therapy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: SupraneApply desflurane as anesthetic | Drug | Desflurane |
Primary outcome
Peak of CTC in the postoperative phase after curative tumor removal
Time frame: Day 0 to Day 7
CTC will be counted and peak of CTC will be determined.
3 secondary outcomes
Kinetics of CTC after surgery up to day 7
Time frame: 1 year
Month to Tumor recurrence
Time frame: 1 year
Number of surviving patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Beck Schimmer, Prof. MD principal investigator
University of Zurich
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane in people with Adenocarcinoma and Circulating Tumor Cells, run by University of Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak of CTC in the postoperative phase after curative tumor removal (time frame: Day 0 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.