Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
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| ClinicalTrials.gov Identifier: NCT02314871 |
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Recruitment Status :
Recruiting
First Posted : December 11, 2014
Last Update Posted : February 23, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colon Cancer Minimal Residual Disease | Other: Epidural analgesia Drug: Piritramide Drug: Morphine | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery |
| Study Start Date : | January 2015 |
| Estimated Primary Completion Date : | May 2018 |
| Estimated Study Completion Date : | September 2018 |
| Arm | Intervention/treatment |
|---|---|
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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
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Other: Epidural analgesia
see Arm/group description
Other Name: Perioperative epidural analgesia |
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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
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Drug: Piritramide
see Arm/group description
Other Name: Postoperative piritramide analgesia |
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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
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Drug: Morphine
see Arm/group description
Other Name: Postoperative morphine analgesia |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314871
| Contact: Emil Berta, MD PhD | 00420608801303 | e.berta@email.cz | |
| Contact: Josef Srovnal, MD PhD | 00420585632111 | srovnalj@upol.cz |
| Czech Republic | |
| Brno University Hospital | Recruiting |
| Brno, Jihomoravsky kraj, Czech Republic, 62500 | |
| Contact: Petr Stourac, MD, PhD +420532233850 stouracp@fnbrno.cz | |
| T. Bata Regional Hospital Zlin | Recruiting |
| Zlin, Jihomoravsky kraj, Czech Republic, 76275 | |
| Contact: Tomas Gabrhelik, MD, PhD +420577552280 Tomas.Gabrhelik@bnzlin.cz | |
| Principal Investigator: | Emil Berta, MD PhD | The Institute of Molecular and Translational Medicine |
Additional Information:
| Responsible Party: | Emil Berta, M.D., Ph.D., Senior Researcher, The Institute of Molecular and Translational Medicine, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT02314871 History of Changes |
| Other Study ID Numbers: |
CAREC-1 |
| First Posted: | December 11, 2014 Key Record Dates |
| Last Update Posted: | February 23, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Emil Berta, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic:
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perioperative analgesia minimal residual disease cancer recurrence epidural morphine |
piritramide colon cancer circulating cancer cells colon cancer surgery |
Additional relevant MeSH terms:
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Pirinitramide Colonic Neoplasms Neoplasm, Residual Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Neoplastic Processes Pathologic Processes Morphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |