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Epidural Versus Patient-controlled Analgesia for Reduction in Long-term Mortality Following Colorectal Cancer Surgery (EPICOL)

This study is currently recruiting participants.
Verified September 2016 by Anil Gupta, Örebro University, Sweden
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318161
First Posted: March 18, 2011
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Hospital, Linkoeping
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
  Purpose
Colorectal cancer is one of the most common cancers in the industrialized world (12% of all cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost half of these cases result in death. Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail.

Condition Intervention Phase
Colorectal Cancer Pain Other Complications Drug: Ropivacaine + opioid epidurally Drug: Morphine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural or Patient-controlled Analgesia for Colorectal Cancer Surgery. Long-term Outcomes.

Resource links provided by NLM:


Further study details as provided by Anil Gupta, Örebro University, Sweden:

Primary Outcome Measures:
  • Long-term (up to 5 yrs) all-cause mortality [ Time Frame: 7 years from start of enrollment ]
    Cancer specific as well as all-cause mortality would be recorded.


Secondary Outcome Measures:
  • Cancer recurrence detected by MRI; perioperative complications [ Time Frame: 7 years following start of enrollment ]
    All complications during the perioperative period including cancer recurrence detected by MRI examination once each year would be recorded.


Other Outcome Measures:
  • Inflammation [ Time Frame: 0-5 days ]
    Perioperative cytokine concentration in blood assessed between randomised groups as well as surgical technique after 100 recruited patients

  • Postoperative pain and early recovery [ Time Frame: 0 - 7 days postoperatively ]
    Aspects of early postoperative recovery until discharge would be measured after 200 recruited patients between randomised groups as well as surgical techniques


Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural anesthesia and analgesia Drug: Ropivacaine + opioid epidurally
Epidural analgesia with local anesthetic + opioid
Active Comparator: Patient controlled analgesia Drug: Morphine
Morphine via PCA pump

Detailed Description:

An application was sent to the Regional Ethics Committee at the Linköping University Hospital and the study was approved recently. Informed consent will be obtained from 300 patients (ASA status 1-3) in the age group 40-80 years who are undergoing elective surgery for colorectal cancer. The exact type of cancer, its staging, degree of spread to proximal or distant sites and the pathologic type of cancer will be recorded. Patients on chronic narcotic analgesic medication, those with known immunologic diseases, those with known allergy to LA and those where epidural catheter placement is contraindicated will be excluded. This study will be a multi-centre study in Central Sweden. Patients will be randomized to one of two groups according to a computer-generated random number: Group E - Epidural anaesthesia (EDA) or Group P - Patient-controlled analgesia (PCA).

Anaesthesia and surgery will be standardized, other than for group randomization. Surgical management of patients in the hospitals will also be standardized. Postoperative parameters will include pain intensity, rescue analgesic (morphine) consumption, surgical complications (e.g., re-operation, surgical site infection, or bleeding), other perioperative complications (e.g., deep vein thrombosis, cardiac complications, or chest infections), cancer recurrence diagnosed by CT or MRI (done yearly over 5 years) and mortality, both cancer-related and all-cause mortality. In addition, blood will be taken preoperatively for analysis of the following inflammatory and immunological markers:

VEGF will be determined in peritoneal fluid and in serum during surgery. HIF-1A will be determined by immunohistochemistry and microRNA measurements in normal and neoplastic colonic mucosa.

In addition, the microRNA mi21 will be analyzed in by quantitative reverse transcriptase-PCR in colon adenocarcinomas and adjacent non-cancerous tissues.

The CTC in whole blood (in 5-7.5 ml) will be measured with the CellSearch System, according to the manufacturer´s instructions, and the Cell Tracks Analyzer II (Cristofanilli M et al. N Engl J Med 2004:351:781-91).

Inflammatory mediator assay-ELISA Patient serum or EDTA/Heparin plasma will be assessed for cytokine levels by a Luminex multiplex assay (Human Inflammation 12-Plex kit; GM.CSF, IFN-g, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, TNF-a and VEGF from R&D system) and PGE2 levels will be measured by an ELISA kit from Cayman Chemicals Company. In addition, markers of systemic inflammatory response, including CRP, white blood cell count, differential count and total platelet count, will also be measured before and after surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status 1-3
  • Age group 40-80 years old
  • Undergoing elective surgery for colorectal cancer

Exclusion Criteria:

  • All contraindications to epidural analgesia
  • Chronic opiate medication/drug abuse
  • Allergy to morphine
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01318161


Locations
Sweden
University Hospital Recruiting
Linköping, Sweden, 581 85
Contact: Christina Eintrei, MD, PhD    +46 0101031835    christina.eintrei@lio.se   
University Hospital Recruiting
Örebro, Sweden, 701 85
Contact: Anil Gupta, MD, FRCA, PhD    +46 19 6020256    anil.gupta@orebroll.se   
Sponsors and Collaborators
Örebro University, Sweden
University Hospital, Linkoeping
  More Information

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01318161     History of Changes
Other Study ID Numbers: 2010/415-31
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Anil Gupta, Örebro University, Sweden:
Epidural analgesia
Patient controlled analgesia
Colorectal cancer
Morbidity
Mortality

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Morphine
Analgesics, Opioid
Ropivacaine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics