Back to resultsEffects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
Primary Purpose
Cancer of Pancreas
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GEA
PCEA
GA
PCIA
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Pancreas focused on measuring Epidural block, Pancreatic cancer
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.
- 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.
Sites / Locations
- Fudan University Shanghai Cancer Center
- Fudan University Zhongshan Hospital
- Fudan University Huashan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
GEA+PCEA
GA+PCIA
Arm Description
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Outcomes
Primary Outcome Measures
Overall survival (OS)
Defined and calculated as the time from the date of surgery to death related to all reasons
Secondary Outcome Measures
Disease-free survival (DFS )
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
Postoperative pain score and side effects of patient-controlled analgesia
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Incidence of delirium
Assessed for delirium using the 3D-CAM instrument
Incidence of persistent post-surgical pain (PPSP) 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
Return of bowel function
Measured by the time of first flatus
Removal of Perianastomotic drains
Removal of Urinary drainage
Removal of nasogastric tube
Blood level of neuroendocrine, stress and inflammatory response
Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Blood levels of ropivacaine and sufentanil
Full Information
NCT ID
NCT03659292
First Posted
September 3, 2018
Last Updated
September 3, 2018
Sponsor
Fudan University
Collaborators
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03659292
Brief Title
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
Official Title
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas
Keywords
Epidural block, Pancreatic cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GEA+PCEA
Arm Type
Experimental
Arm Description
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
Arm Title
GA+PCIA
Arm Type
Other
Arm Description
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Intervention Type
Other
Intervention Name(s)
GEA
Other Intervention Name(s)
General anesthesia combined with epidural anesthesia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PCEA
Other Intervention Name(s)
Patient-controlled epidural analgesia
Intervention Description
Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.
Intervention Type
Other
Intervention Name(s)
GA
Other Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
Intervention Type
Other
Intervention Name(s)
PCIA
Other Intervention Name(s)
Patient-controlled intravenous analgesia
Intervention Description
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Defined and calculated as the time from the date of surgery to death related to all reasons
Time Frame
During 2 years after surgery
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS )
Description
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
Time Frame
During 2 years after surgery
Title
Postoperative pain score and side effects of patient-controlled analgesia
Description
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Time Frame
During the first 48 hours after surgery
Title
Incidence of delirium
Description
Assessed for delirium using the 3D-CAM instrument
Time Frame
During the first 1 week after surgery
Title
Incidence of persistent post-surgical pain (PPSP) after surgery
Description
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Time Frame
During 2 years after surgery
Title
Length of stay in hospital after surgery
Time Frame
During the first 30 days after surgery
Title
Return of bowel function
Description
Measured by the time of first flatus
Time Frame
During the first 30 days after surgery
Title
Removal of Perianastomotic drains
Time Frame
During the first 30 days after surgery
Title
Removal of Urinary drainage
Time Frame
During the first 30 days after surgery
Title
Removal of nasogastric tube
Time Frame
During the first 30 days after surgery
Title
Blood level of neuroendocrine, stress and inflammatory response
Description
Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
Time Frame
During surgery and the first 24 hours after surgery
Title
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Time Frame
During 2 years after surgery
Title
Blood levels of ropivacaine and sufentanil
Time Frame
During surgery and the first 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changhong Miao
Phone
+86-021-64175590
Ext
82420
Email
miaochh@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuqin Zhu
Phone
+86-021-64175590
Ext
82420
Email
zhuxuqin1101@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changhong Miao
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qianjin Liu
Organizational Affiliation
Washington University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changhong Miao
Phone
+86-021-64175590
Ext
82420
Email
miaochh@aliyun.com
First Name & Middle Initial & Last Name & Degree
Xuqin Zhu
Phone
+86-021-64175590
Ext
82420
Email
zhuxuqin1101@sina.com
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Cang
Phone
+86-139-1601-0421
Email
cangjing1998@aliyun.com
Facility Name
Fudan University Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingwei Wang
Phone
+86-139-1869-0528
Email
wangyingwei@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
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