Clinical trial NCT03245346: Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery
Official title: Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Pancreas
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2017-08-10
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: During 2 years after surgery
Secondary outcomes:
measure: Disease-free survival (DFS )
timeFrame: During 2 years after surgery
measure: Postoperative pain score and side effects of patient-controlled analgesia
timeFrame: During the first 48 hours after surgery
measure: Incidence of delirium
timeFrame: During the first 1 week after surgery
measure: Incidence of persistent post-surgical pain (PPSP) after surgery
timeFrame: During 2 years after surgery
measure: Length of stay in hospital after surgery and total costs after surgery
timeFrame: During the first 30 days after surgery
measure: Return of bowel function
timeFrame: During the first 30 days after surgery
measure: Start of enteral tube feeding
timeFrame: During the first 30 days after surgery
measure: Removal of Perianastomotic drains
timeFrame: During the first 30 days after surgery
measure: Removal of Urinary drainage
timeFrame: During the first 30 days after surgery
measure: Removal of nasogastric tube
timeFrame: During the first 30 days after surgery
measure: Removal of enteral feeding tube
timeFrame: During the first 30 days after surgery
measure: Blood level of neuroendocrine, stress and inflammatory response
timeFrame: During surgery and the first 24 hours after surgery (post-operative day 1)
measure: Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
timeFrame: During 2 years after surgery
measure: Plasma levels of ropivacaine and sufentanil
timeFrame: During surgery and the first 24 hours after surgery (post-operative day 1)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Changhong Miao
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Qianjin Liu
role: STUDY_DIRECTOR
References:
citation: Zhang H, Qu M, Guo K, Wang Y, Gu J, Wu H, Zhu X, Sun Z, Cata JP, Chen W, Miao C. Intraoperative lidocaine infusion in patients undergoing pancreatectomy for pancreatic cancer: a mechanistic, multicentre randomised clinical trial. Br J Anaesth. 2022 Aug;129(2):244-253. doi: 10.1016/j.bja.2022.03.031. Epub 2022 Jun 11.