Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial

Trial ID: NCT04025840

Interventional - Phase 4 - Active, not recruiting

Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.

Conditions

• Pancreatic Cancer
• Surgery
• Epidural Block
• Dexamethasone
• Overall Survival

Interventions

• Epidural block
• Dexamethasone

Eligibility

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.

Sponsor

Peking University First Hospital, Peking University Cancer Hospital & Institute, The Second Affiliated Hospital of Chongqing Medical University

Source: ClinicalTrials.gov

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