- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245346
Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery
December 9, 2019 updated by: Changhong Miao, Fudan University
Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
540
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Changhong Miao
- Phone Number: +86-021-64175590
- Email: miaochh@aliyun.com
Study Contact Backup
- Name: Xuqin Zhu
- Phone Number: +86-021-64175590
- Email: zhuxuqin1101@sina.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Xuqin Zhu
- Phone Number: +86-021-64175590
- Email: zhuxuqin1101@sina.com
-
Contact:
- Changhao Miao
- Phone Number: +86-021-64175590
- Email: miaochh@aliyun.com
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Zhongshan Hospital
-
Contact:
- Jing Cang
- Phone Number: +86-139-1601-0421
- Email: cangjing1998@aliyun.com
-
Shanghai, Shanghai, China, 200040
- Not yet recruiting
- Fudan University Huashan Hospital
-
Contact:
- Yingwei Wang
- Phone Number: +86-139-1869-0528
- Email: wangyingwei@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Undergoing elective pancreaticoduodenectomy 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 anesthesia and analgesia.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
|
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.
Other Names:
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
Other Names:
|
Other: GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) 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.
Other Names:
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During 2 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival (DFS )
Time Frame: 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
|
During 2 years after surgery
|
Postoperative pain score and side effects of patient-controlled analgesia
Time Frame: During the first 48 hours after surgery
|
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
|
During the first 48 hours after surgery
|
Incidence of delirium
Time Frame: During the first 1 week after surgery
|
Assessed for delirium using the 3D-CAM instrument
|
During the first 1 week after surgery
|
Incidence of persistent post-surgical pain (PPSP) after surgery
Time Frame: During 2 years after surgery
|
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
|
During 2 years after surgery
|
Length of stay in hospital after surgery and total costs after surgery
Time Frame: During the first 30 days after surgery
|
During the first 30 days after surgery
|
|
Return of bowel function
Time Frame: During the first 30 days after surgery
|
Measured by the time of first flatus
|
During the first 30 days after surgery
|
Start of enteral tube feeding
Time Frame: During the first 30 days after surgery
|
Measured by the time of first enteral tube feeding after surgery
|
During the first 30 days after surgery
|
Removal of Perianastomotic drains
Time Frame: During the first 30 days after surgery
|
During the first 30 days after surgery
|
|
Removal of Urinary drainage
Time Frame: During the first 30 days after surgery
|
During the first 30 days after surgery
|
|
Removal of nasogastric tube
Time Frame: During the first 30 days after surgery
|
During the first 30 days after surgery
|
|
Removal of enteral feeding tube
Time Frame: During the first 30 days after surgery
|
During the first 30 days after surgery
|
|
Blood level of neuroendocrine, stress and inflammatory response
Time Frame: 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)
|
During surgery and the first 24 hours after surgery (post-operative day 1)
|
Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Time Frame: During 2 years after surgery
|
During 2 years after surgery
|
|
Plasma levels of ropivacaine and sufentanil
Time Frame: During surgery and the first 24 hours after surgery (post-operative day 1)
|
During surgery and the first 24 hours after surgery (post-operative day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Changhong Miao, Fudan University
- Study Director: Qianjin Liu, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2017
Primary Completion (Anticipated)
December 18, 2021
Study Completion (Anticipated)
December 18, 2021
Study Registration Dates
First Submitted
August 2, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 10, 2017
Study Record Updates
Last Update Posted (Actual)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDUSCCA-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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