Epidural block and dexamethasone for pancreatic cancer surgery
Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial
This study tests if using an epidural block and dexamethasone during surgery for pancreatic cancer can help patients live longer and recover better compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 45 Years to 90 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04025840 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of perioperative epidural block and dexamethasone on long-term survival in patients undergoing radical surgery for resectable pancreatic cancer. The study aims to determine if these interventions can improve postoperative outcomes by enhancing pain relief, reducing opioid use, and potentially preserving immune function. Participants will be randomly assigned to receive either the interventions or standard care, and their survival rates will be monitored over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 90 with clinically diagnosed resectable pancreatic cancer scheduled for radical surgery.
Not a fit: Patients with unresectable pancreatic cancer or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve overall survival rates for patients undergoing surgery for pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential benefits in cancer surgery outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥45 and \<90 years; 2. Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery; 3. Agreed to receive epidural block and postoperative patient-controlled analgesia; 4. Agreed to participate in the study and provided written informed consent. Exclusion Criteria: 1. Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy; 2. Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis; 3. Complicated with primary malignant tumor in other organ(s), either previously or at present; 4. Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery; 5. Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases; 6. Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine \>442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V； 7. Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain; 8. Other conditions that are considered unsuitable for study participation; 9. Refused to participate in the study.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: 86 (10) 83572784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.