Anesthesia and Immunological and Oxidative Stress in Relation to Abdominal Cancer Surgery

NCT03974984 | Withdrawn

• 1 other identifier: SJ-704
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is a frequent type of cancer accounting for 600,000 deaths annually. Surgical resection remains the best treatment for long-term survival. However, studies suggest that events in the perioperative period can induce metastasis formation and tumor growth. Tumor cells are released into the blood stream during surgery and the surgical stress may create a favorable environment for dissemination of tumor cells into distant tissue. This is done by a cascade of pro-cancerous catecholamines, prostaglandins and cytokines combined with an impaired anti-cancerous cell mediated immune response. Until recently, focus on the anesthetic management of cancer patients has been limited. Relatively small alterations in the perioperative anesthetic management may play a tremendous role in tumor progression. Optimizing anesthesia to reduce the surgical stress response could improve recurrence rates and long-term outcomes for cancer patients by inhibiting perioperative metastasis formation. Regional anesthesia and amide local anesthetics are suspected to calm the immunologic storm of prostaglandins, catecholamines and cytokines when used in the perioperative phase. Furthermore, volatile inhalational anesthesia is thought to modulate the immune system in a pro-cancerous way, while propofol may have opposite effects. Many of these recent studies are statistically underpowered and susceptible to bias, and experts in cancer treatment and anesthesia have emphasized the need for further research within this specific field. In this study the investigators aim to characterize differences in the immunologic response to surgery between inhalational, total intravenous and epidural anesthesia. This will be done by analyzing blood samples obtained in the perioperative period in patients undergoing different modes of anesthesia. The Investigators will furthermore describe the quality of recovery for patients anesthetized with the different methods

Conditions

Anesthesia; Colon Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Changes in neutrophil to lymphocyte ratio from preoperatively to day 1 postoperatively

  Changes in neutrophil to lymphocyte ratio from day 0 to day 1. The ratio will be estimated using absolute numbers from differential counts pre and postoperatively. A high neutrophil to lymfocyte ratio is related to poor outcome after cancer surgery

  From preoperatively to day 1 postoperatively

Secondary Outcomes (1)

• Changes in quality of recovery-15 score from preoperatively to day 1 postoperatively.

  Difference from preoperatively to day 1 postoperatively

Study Arms (2)

The "Hvidovre population":

We will include patients undergoing laparoscopic hemicolectomy for cancer scheduled for anesthesia with total intravenous anesthesia combined with epidural anesthesia and perioperative NSAID on Hvidovre Hospital.

Procedure: Colon Resection; Procedure: Epidural anesthesia; Drug: NSAID

The "Zealand University Hospital population"

The immunological and oxidative stress in relation to abdominal surgery (IMOX) study is ongoing at Zealand University Hospital, Roskilde. It is a prospective explorative study cohort that consists of 60 patients undergoing laparoscopic colorectal cancer surgery. The population has been anesthetized according to the standard operating procedure with either total intravenous anesthesia with propofol and remifentanil or volatile anesthesia with sevoflurane combined with a fast acting opioid (remifentanil or sufentanil). Patients anaesthetized with other techniques including epidural or other regional blocks will be excluded from the analysis.

Procedure: Colon Resection

Interventions

Colon Resection PROCEDURE

All patients undergo laparoscopic colon cancer resection.

The "Hvidovre population":; The "Zealand University Hospital population"

Epidural anesthesia PROCEDURE

Epidural inserted preoperatively and kept for 1 day postoperatively

The "Hvidovre population":

NSAID DRUG

NSAID administered according to standard operating procedure postoperatively

The "Hvidovre population":

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include patients undergoing laparoscopic hemicolectomy for cancer scheduled for anesthesia with total intravenous anesthesia combined with epidural anesthesia on Hvidovre Hospital

You may qualify if:

• Patients over 18 years
• Patients diagnosed with colorectal cancer (UICC stadium I-III) and scheduled for laparoscopic hemicolectomy.
• ASA class I-III (Classification of the American Society of Anesthesiology)
• Patients scheduled for anesthesia with propofol, remifentanil and epidural anesthesia.
• Signed informed consent

You may not qualify if:

• Known immune-defects
• Patients undergoing neoadjuvant chemo or radiotherapy
• History of previous cancer
• Patients in immunomodulatory treatment within last 6 months
• Daily oral or intravenous steroid-use
• Patients that have undergone major surgery within one month before planned colon resection.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Hvidovre University hospital

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (24)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard blood samples analyzed immediately after sampling. These include Hgb, Leucocytes including a differential count, thrombocytes, ALAT, LDH, Alkaline phosphatase, bilirubin, INR, albumin, Na, K, Creatinine, CRP and Glucose.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Anesthesia, Epidural; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: June 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

DK (1)