Status:
UNKNOWN
Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Cancer of Pancreas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this randomized controlled trial is to investigate the effects of epidural anesthesia and analgesia on the overall survival，disease-free survival and recovery in patients undergoing pan...
Eligibility Criteria
Inclusion
- Undergoing elective pancreaticoduodenectomy for pancreatic cancer .
- ASA statusⅠ-Ⅲ.
- 18 years to 80 years （adults）.
- Able to understand, communicate and sign an informed consent form.
Exclusion
- Laparoscopic surgery.
- Preoperative chemotherapy or radiotherapy.
- Pregnancy.
- Allergic to any drugs used during the study.
- Long-term receiving β-blockers.
- Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
- Abnormal coagulation functions (platelet count prior to surgery \<100000/ μL , APTT value is more than the normal value, INR \> 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
- Complicated with severe heart disease (NYHA classification \>3), severe renal insufficiency (serum creatinine \>1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification
- = C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC\>10000/μL) before surgery.
- BMI \> 35.
- All contraindications to epidural anesthesia and analgesia.
- Chronic opiate medication/drug abuse.
- Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
- Refuse to sign an informed consent form.
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2021
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03245346
Start Date
December 19 2017
End Date
December 18 2021
Last Update
December 11 2019
Active Locations (3)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
3
Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040