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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314871
• Other study ID #: CAREC-1
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Minimal Residual Disease
• Neoplasm, Residual

Intervention

Other:
• Epidural analgesia
see Arm/group description

Drug:
• Piritramide
see Arm/group description
• Morphine
see Arm/group description

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	Jihomoravsky Kraj
Czechia	T. Bata Regional Hospital Zlin	Zlin	Jihomoravsky Kraj

Sponsors (3)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	Brno University Hospital, Tomas Bata Hospital, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline number of circulating cancer cells at 3 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.	Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery
Secondary	Pain intensity assessment	Self reported pain intensity. Scale: 0 = no pain, 10 = worst pain imaginable. A score 0-10 will be recorded every four hours.	3 days postoperatively

External Links

•   The Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry Palacky University Olomouc