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NCT Number: NCT02314871

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brno University Hospital, Brno, South Moravian, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Epidural analgesia

Other

see Arm/group description

Other names: Perioperative epidural analgesia

Piritramide

Drug

see Arm/group description

Other names: Postoperative piritramide analgesia

Morphine

Drug

see Arm/group description

Other names: Postoperative morphine analgesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • Brno University Hospital
  • Tomas Bata Hospital, Czech Republic

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2014
Registry last updated
Mar 13, 2019

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

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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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