Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
1 other identifier
interventional
540
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 3, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedSeptember 6, 2018
September 1, 2018
4.1 years
September 3, 2018
September 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Defined and calculated as the time from the date of surgery to death related to all reasons
During 2 years after surgery
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
GEA+PCEA
EXPERIMENTALGeneral anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
GA+PCIA
OTHERGeneral anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Interventions
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.
Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Eligibility Criteria
You may qualify if:
- Undergoing elective distal pancreatectomy for pancreatic cancer .
- ASA statusⅠ-Ⅲ.
- years to 80 years （adults）.
- Able to understand, communicate and sign an informed consent form.
You may not qualify if:
- 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 block.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Washington University School of Medicinecollaborator
Study Sites (3)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changhong Miao
Fudan University
- STUDY DIRECTOR
Qianjin Liu
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
Study Record Dates
First Submitted
September 3, 2018
First Posted
September 6, 2018
Study Start
September 1, 2018
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
September 6, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share