Clinical trial · Interventional
Perioperative Epidural Block and Dexamethasone in 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
NCT04025840CI-TRIAL-00092906active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dexamethasone | — | UNRESOLVED | — |
| Epidural Block | — | UNRESOLVED | — |
| Overall Survival | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Epidural block | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
- type
- EXPERIMENTAL
- label
- Epidural block
- description
- Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.
- interventionNames
- Other: Epidural block
- type
- EXPERIMENTAL
- label
- Dexamethasone
- description
- Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (38)
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- BACKGROUNDChen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01. PMID 29545714
- BACKGROUNDKamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30. PMID 26830752
- BACKGROUNDYeo CJ, Cameron JL. Prognostic factors in ductal pancreatic cancer. Langenbecks Arch Surg. 1998 Apr;383(2):129-33. doi: 10.1007/s004230050104. PMID 9641885
- BACKGROUNDWinter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1. doi: 10.1016/j.gassur.2006.08.018.