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Completed

NCT Number: NCT02335151

CTC Pancreatic Adenocarcinoma

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)

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Key information

Conditions

Adenocarcinoma Carcinoma Circulating Tumor Cells Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Cells, Circulating Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kantonsspital St. Gallen, Sankt Gallen, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Apply desflurane as anesthetic

Other names: Suprane

Primary outcomes

  1. 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.

Secondary outcomes

  1. Kinetics of CTC after surgery up to day 7

    Time frame: 1 year

    CTC will be counted and kinetics of CTC will be determined.

  2. Month to Tumor recurrence

    Time frame: 1 year

    Tumor recurrence will be monitored.

  3. Number of surviving patients

    Time frame: 1 year

    One year after surgery the number of patients still being alive will be determined.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Cantonal Hospital of St. Gallen
  • Kantonsspital Winterthur KSW
  • Triemli Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2015
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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