Colorectal NeoplasmsNCT01978717
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
A study testing epidural anesthesia and general anesthesia in people with Colorectal Neoplasms, run by Changhong Miao at 1 site in China.
Trial summary
The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis. Read more about this study
- Who is it for?
- Ages 51 to 65 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- epidural anesthesia and general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Colorectal Cancer(CRC);
- subjected to the Fast-Track processing of surgery;
- between 18 and 75 years old.
Who cannot join
- American Society of Anesthesiologists(ASA) grade > III;
- BMI > 30;
- a history of abdominal surgery, endocrine or immune system dysfunction;
- recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
- previous contraindication to epidural anesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhong Shan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.
- Conditions
- Colorectal Neoplasms
- Being tested
- epidural anesthesia, general anesthesia
- Keywords
- Anesthesia, T-helper, MDSCs, Colorectal cancer, Fast track
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaProcedure or surgery
general anesthesiaProcedure or surgery
Patients received general anesthesia for surgery
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia & epidural anesthesia | Experimental | 26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery Receives: Procedure: epidural anesthesia; Procedure: general anesthesia |
| general anesthesia | Experimental | 27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of peripheral immune cells and cytokines
The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines
Measured: within the first 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhong Miao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changhong Miao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978717
- Sponsor's protocol ID
- NO.2011-197
- Other IDs
- 08431910200
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20.
PubMed 23437162
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01978717
- Acronym / sponsor ID
- NO.2011-197
- Conditions
- Colorectal Neoplasms
- Keywords
- Anesthesia, T-helper, MDSCs, Colorectal cancer, Fast track
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Changhong MiaoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia & epidural anesthesia | Experimental | Procedure: epidural anesthesia, Procedure: general anesthesia26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery |
| general anesthesia | Experimental | Procedure: general anesthesia27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery |
Who may qualify
- Ages
- 51 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with Colorectal Cancer(CRC);
- subjected to the Fast-Track processing of surgery;
- between 18 and 75 years old.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists(ASA) grade > III;
- BMI > 30;
- a history of abdominal surgery, endocrine or immune system dysfunction;
- recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
- previous contraindication to epidural anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural anesthesia | Procedure or surgery | general anesthesia & epidural anesthesia |
| general anesthesiaPatients received general anesthesia for surgery | Procedure or surgery | general anesthesia, general anesthesia & epidural anesthesia |
Primary outcome
The changes of peripheral immune cells and cytokines
Time frame: within the first 5 days after surgery
The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Background: PubMed 23437162Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural anesthesia and general anesthesia in people with Colorectal Neoplasms, run by Changhong Miao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of peripheral immune cells and cytokines (time frame: within the first 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.