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Trial record 32 of 3586 for:    colon cancer AND Colonic Diseases

Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery

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ClinicalTrials.gov Identifier: NCT02314871
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Brno University Hospital
Tomas Bata Hospital, Czech Republic
Information provided by (Responsible Party):
Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Change from baseline number of circulating cancer cells at 3 weeks after surgery [ Time Frame: Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery ]
Number of circulating cancer cells will be measured in venous blood samples. The quantitative real-time polymerase chain reaction using carcinoembryonic antigen and cytokeratine 20 as markers for circulating cancer cells will be used for minimal residual disease detection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02314871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Pain intensity assessment [ Time Frame: 3 days postoperatively ]
Self reported pain intensity. Scale: 0 = no pain, 10 = worst pain imaginable. A score 0-10 will be recorded every four hours.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
Official Title  ICMJE Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
Brief Summary The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.
Detailed Description

Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.

The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Cancer
  • Minimal Residual Disease
Intervention  ICMJE
  • Other: Epidural analgesia
    see Arm/group description
    Other Name: Perioperative epidural analgesia
  • Drug: Piritramide
    see Arm/group description
    Other Name: Postoperative piritramide analgesia
  • Drug: Morphine
    see Arm/group description
    Other Name: Postoperative morphine analgesia
Study Arms  ICMJE
  • Active Comparator: Epidural
    Patients will receive perioperative epidural analgesia. Drugs: bupivacaine 1.25 mg/ml and sufentanil 0.5 mcg/ml Form and frequency: continuous infusion Dosage: 4 - 14 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required
    Intervention: Other: Epidural analgesia
  • Active Comparator: Piritramide
    Patients will receive postoperative analgesia with piritramide. Drugs: piritramide 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required
    Intervention: Drug: Piritramide
  • Active Comparator: Morphine
    Patients will receive postoperative analgesia with morphine. Drugs: morphine 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required
    Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing open radical surgery for colon cancer (without known extension beyond colon)
  • Age over 18 years
  • Written informed consent

Exclusion Criteria:

  • Allergy or intolerance of morphine, piritramide, marcaine, sufentanil or volatile anesthetics
  • History of colon cancer resection
  • Other cancer present (apart from those in complete long-term remission for minimum 6 months)
  • Chronic opioid medication and/or opioid administration 7 days or less prior to surgery
  • Any contraindication to thoracic epidural anesthesia/analgesia
  • Systemic therapy with immunosuppressive drugs or corticoids (apart from topical and inhalational)
  • Any surgery within the last 30 days (apart from minor day-case procedures)  - Chronic or acute infectious disease, particularly hepatitis, AIDS, tuberculosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02314871
Other Study ID Numbers  ICMJE CAREC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic
Study Sponsor  ICMJE The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators  ICMJE
  • Brno University Hospital
  • Tomas Bata Hospital, Czech Republic
Investigators  ICMJE
Principal Investigator: Emil Berta, MD PhD The Institute of Molecular and Translational Medicine
PRS Account The Institute of Molecular and Translational Medicine, Czech Republic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP