How opioid-free, opioid-sparing, and opioid-based anesthesia affect immune markers and cancer cell behavior after colorectal cancer surgery
Official title: Effect of Opioid-Free, Opioid-sparing Versus Opioid-based Anesthesia on Perioperative NETs and Cancer Cell Malignancy in Patients Undergoing Surgery for Colorectal Cancer: A Randomized, Controlled Trial
Run by Fudan University · NCT07264556 · Data updated 2026-11-12
This trial will test whether opioid-free or opioid-sparing anesthesia versus standard opioid-based anesthesia changes immune markers and affects cancer cell behavior in adults having elective colorectal cancer surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 30, 2025 |
| Study ends | December 15, 2025 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07264556 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 years old with ASA physical status I–III who are scheduled for elective colorectal cancer surgery under general anesthesia at the enrolling center.
✕Probably not a fit
Patients with prior colorectal surgery, recent chemotherapy or radiotherapy within 8 weeks, opioid addiction, serious major organ disease, or contraindications to the anesthetic techniques are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–80 with ASA physical status I–III undergoing elective colorectal cancer surgery were randomized to receive opioid-free anesthesia, opioid-sparing anesthesia, or conventional opioid-based anesthesia. Blood samples were collected before surgery and 24 hours after surgery to measure neutrophil extracellular trap markers (including MPO and citrullinated histone H3) as primary endpoints. Secondary endpoints include the effect of postoperative serum on colorectal cancer cell malignancy in laboratory assays, postoperative pain scores, adverse events, and recovery profiles. The opioid-based arm uses remifentanil and sufentanil intraoperatively with postoperative patient-controlled IV analgesia, while the other arms reduce or omit intraoperative and postoperative opioids.
Why it matters
Potential benefit: If successful, changing the anesthesia approach could reduce pro‑tumor immune signals after surgery and potentially lower cancer cell aggressiveness, which might improve long‑term outcomes.
How similar studies have gone: Prior research has suggested opioids can alter immune function and perioperative factors may influence cancer biology, but results are mixed and direct comparisons of opioid-free versus opioid-sparing versus opioid-based approaches remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18-80 years old, * American Society of Anesthesiologists physical status I-III, * elective colorectal cancer surgery under general anesthesia Exclusion Criteria: * previous history of colorectal surgery, * addicted to opioids, * serious major mental or physical illness (heart, pulmonary, hepatic, or renal diseases), * radiotherapy or chemotherapy history within 8 weeks prior to the surgery, * contraindications to anesthetic agents or epidural.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lingling Gao, MD
- Email: LinglingGao@aliyun.com
- Phone: 086-18818211563
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Knife-assisted full-thickness resection for rectal lesions in a multicenter setting
A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.
-
Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model
This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery
Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.
-
Liver transplantation for colorectal cancer with liver metastases
This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.
-
LTZ-232: a first-in-human test in advanced colorectal and other solid tumors
A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.