Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial

Fudan University3 sites in 1 country540 target enrollmentSeptember 2018

ConditionsCancer of Pancreas

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer of Pancreas
Sponsor: Fudan University
Enrollment: 540
Locations: 3
Primary Endpoint: Overall survival (OS)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.

Registry

clinicaltrials.gov

Start Date

September 2018

End Date

October 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Changhong Miao

Director of Anesthesiology Department of Fudan University Shanghai Cancer Center

Fudan University

Eligibility Criteria

Inclusion Criteria

•Undergoing elective distal pancreatectomy for pancreatic cancer .
•ASA statusⅠ-Ⅲ.
•18 years to 80 years （adults）.
•Able to understand, communicate and sign an informed consent form.

Exclusion Criteria

•Laparoscopic surgery.
•Preoperative chemotherapy or radiotherapy.
•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.
•All contraindications to epidural block.
•Chronic opiate medication/drug abuse.
•Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: During 2 years after surgery

Defined and calculated as the time from the date of surgery to death related to all reasons

Secondary Outcomes

Disease-free survival (DFS )(During 2 years after surgery)
Postoperative pain score and side effects of patient-controlled analgesia(During the first 48 hours after surgery)
Incidence of delirium(During the first 1 week after surgery)
Incidence of persistent post-surgical pain (PPSP) after surgery(During 2 years after surgery)
Length of stay in hospital after surgery(During the first 30 days after surgery)
Return of bowel function(During the first 30 days after surgery)
Removal of Perianastomotic drains(During the first 30 days after surgery)
Removal of Urinary drainage(During the first 30 days after surgery)
Removal of nasogastric 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)
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels(During 2 years after surgery)
Blood levels of ropivacaine and sufentanil(During surgery and the first 24 hours after surgery)