Cancer of Pancreas
Conditions
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 pancreatic cancer surgery. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.
Interventions
DRUGGEA
Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
DRUGPCEA
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
DRUGGA
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
DRUGPCIA
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Sponsors
Washington University School of Medicine
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Undergoing elective pancreaticoduodenectomy for pancreatic cancer . 2. ASA statusⅠ-Ⅲ. 3. 18 years to 80 years （adults）. 4. Able to understand, communicate and sign an informed consent form.
Exclusion criteria
1. Laparoscopic surgery. 2. Preoperative chemotherapy or radiotherapy. 3. Pregnancy. 4. Allergic to any drugs used during the study. 5. Long-term receiving β-blockers. 6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery. 7. 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). 8. 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. 9. BMI \> 35. 10. All contraindications to epidural anesthesia and analgesia. 11. Chronic opiate medication/drug abuse. 12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study. 13. Refuse to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | During 2 years after surgery | Defined and calculated as the time from the date of surgery to death related to all reasons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score and side effects of patient-controlled analgesia | During the first 48 hours after surgery | Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain) |
| Incidence of delirium | During the first 1 week after surgery | Assessed for delirium using the 3D-CAM instrument |
| Incidence of persistent post-surgical pain (PPSP) after surgery | During 2 years after surgery | Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain) |
| Length of stay in hospital after surgery and total costs after surgery | During the first 30 days after surgery | — |
| Return of bowel function | During the first 30 days after surgery | Measured by the time of first flatus |
| Start of enteral tube feeding | During the first 30 days after surgery | Measured by the time of first enteral tube feeding after surgery |
| Disease-free survival (DFS ) | During 2 years after surgery | Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death |
| Removal of Urinary drainage | During the first 30 days after surgery | — |
| Removal of nasogastric tube | During the first 30 days after surgery | — |
| Removal of enteral feeding tube | During the first 30 days after surgery | — |
| Blood level of neuroendocrine, stress and inflammatory response | During surgery and the first 24 hours after surgery (post-operative day 1) | Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio) |
| Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels | During 2 years after surgery | — |
| Plasma levels of ropivacaine and sufentanil | During surgery and the first 24 hours after surgery (post-operative day 1) | — |
| Removal of Perianastomotic drains | During the first 30 days after surgery | — |
Countries
China
Contacts
Primary ContactChanghong Miao
Backup ContactXuqin Zhu
Outcome results
None listed