Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 998 for:    colon cancer AND resection

The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved

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.
 
ClinicalTrials.gov Identifier: NCT03193710
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Guizhi Du, West China Hospital

Brief Summary:
The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Survival Rate General Anesthetics Toxicity Lymphocyte Destruction Molecular Mechanism of Pharmacological Action Drug: Propofol Drug: Sevoflurane Drug: Remifentanil

Detailed Description:
With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Total intravenous anesthesia group
The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.
Drug: Propofol
Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.
Other Name: Diprivan

Drug: Remifentanil
Remifentanil will be used for analgesia in both groups.
Other Name: YiChang HumanWell Pharmaceutical Co.,LTD. China

Inhalational anesthesia group
The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.
Drug: Sevoflurane
Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.
Other Name: Abbvie

Drug: Remifentanil
Remifentanil will be used for analgesia in both groups.
Other Name: YiChang HumanWell Pharmaceutical Co.,LTD. China




Primary Outcome Measures :
  1. Change from baseline lymphocytes within postoperative 5 years [ Time Frame: up to 5 years ]
    Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells

  2. Cancer free survival [ Time Frame: 5 years or as available ]
    Patients who remain alive without known colonal or rectal tumor recurrence


Secondary Outcome Measures :
  1. Cancer recurrence rate [ Time Frame: up to 5 years ]
    Patients who remain alive with known colonal or rectal tumor recurrence

  2. Cancer metastasis rate [ Time Frame: up to 5 years ]
    Patients who remain alive with known colonal or rectal tumor metastasis

  3. Re-operation [ Time Frame: up to 5 years ]
    Patients who have a surgery under general anesthesia

  4. Anesthesia scheme for re-operation [ Time Frame: up to 5 years ]
    Total intravenous anesthesia, inhalational anesthesia or combined anesthesia

  5. Radiotherapy rate for any cancer [ Time Frame: up to 5 years ]
    Patients have radiotherapy for any cancer

  6. Chemotherapy rate for any cancer [ Time Frame: up to 5 years ]
    Patients have chemotherapy for any cancer

  7. Circulating tumor cells [ Time Frame: up to 5 years ]
    Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing circulating tumor cells

  8. Concentration of cytokines [ Time Frame: up to 5 years ]
    Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing IL, TNF-α, IFN-γ and GCSF

  9. Colorectal cancer antibodies [ Time Frame: up to 5 years ]
    Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CEA, CA199, GP87 and TPA.


Other Outcome Measures:
  1. Re-operation during hospitalization [ Time Frame: From end of colorectal cancer resection surgery to discharge, up to one month ]
    Patients receive a reoperation for any reason during hospitalization

  2. Days of hospitalization [ Time Frame: From end of colorectal cancer resection surgery to discharge, up to one month ]
    The duration of patients stay in hospital


Biospecimen Retention:   Samples Without DNA
Blood of the enrolled patients will be sampled at different time-points for examination of lymphocytes.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia
Criteria

Inclusion Criteria:

  • All the patients diagnosed with colonal or rectal cancer
  • Aged 18-65
  • ASA I-III
  • Assigned to receive resection surgery under general anesthesia, with an expected duration of 2 hours or more
  • Agree to participate and give signed written informed consent.

Exclusion Criteria:

  • Severe organic heart, liver and kidney diseases
  • Diabetes or hemopoietic disorders
  • Allergy to general anesthetics
  • Family historical malignant hyperthermia
  • Cognition dysfunction
  • End-stage cancer or with over 2 cancer metastasis, pathological results were benign tumor or TNM stage was over T1- 3N0 - 2M0
  • Other primary malignant tumor
  • Immune deficiency or dysfunction or autoimmune disease or long-term usage of corticoids or immunosuppressants
  • Receiving general anesthesia within the last 3 months before the resection surgery
  • Perioperative transfusion

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): NCT03193710


Contacts
Layout table for location contacts
Contact: Guizhi Du, MD, PhD +8618980602213 du_guizhi@yahoo.com
Contact: Jin Liu, MD, PhD +86 18980601549 scujinliu@foxmail.com

Locations
Layout table for location information
China, Sichuan
West China Hospital of Sichuan University, Department of Anesthesiology Recruiting
Chengdu, Sichuan, China, 610041
Contact: Guizhi Du, MD, PhD    +86-189-8060-2213    du_guizhi@yahoo.com   
Principal Investigator: Guizhi Du, MD, PhD         
Sub-Investigator: Yan Qiu, MD         
Sponsors and Collaborators
Guizhi Du
Investigators
Layout table for investigator information
Study Chair: Jin Liu, MD, PhD Department of Anesthesiology, West China Hospital

Publications:

Layout table for additonal information
Responsible Party: Guizhi Du, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03193710     History of Changes
Other Study ID Numbers: WestChinaHospital
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the study outcomes
Keywords provided by Guizhi Du, West China Hospital:
Intravenous anesthesia
Inhalational anesthesia
Colorectal cancer resection
Lymphocytes
Metastasis
Survival
Molecular mechanism
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Remifentanil
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation