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Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy

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ClinicalTrials.gov Identifier: NCT03659292
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Changhong Miao, Fudan University

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.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Other: GEA Other: PCEA Other: GA Other: PCIA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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.
Other: GEA
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 Name: General anesthesia combined with epidural anesthesia

Other: PCEA
Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.
Other Name: Patient-controlled epidural analgesia

GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Other: GA
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
Other Name: General anesthesia

Other: PCIA
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Other Name: Patient-controlled intravenous analgesia




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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)

  3. Incidence of delirium [ Time Frame: During the first 1 week after surgery ]
    Assessed for delirium using the 3D-CAM instrument

  4. 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)

  5. Length of stay in hospital after surgery [ Time Frame: During the first 30 days after surgery ]
  6. Return of bowel function [ Time Frame: During the first 30 days after surgery ]
    Measured by the time of first flatus

  7. Removal of Perianastomotic drains [ Time Frame: During the first 30 days after surgery ]
  8. Removal of Urinary drainage [ Time Frame: During the first 30 days after surgery ]
  9. Removal of nasogastric tube [ Time Frame: During the first 30 days after surgery ]
  10. Blood level of neuroendocrine, stress and inflammatory response [ Time Frame: During surgery and the first 24 hours after surgery ]
    Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)

  11. Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels [ Time Frame: During 2 years after surgery ]
  12. Blood levels of ropivacaine and sufentanil [ Time Frame: During surgery and the first 24 hours after surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Undergoing elective distal pancreatectomy 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 block.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659292


Contacts
Contact: Changhong Miao +86-021-64175590 ext 82420 miaochh@aliyun.com
Contact: Xuqin Zhu +86-021-64175590 ext 82420 zhuxuqin1101@sina.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Changhong Miao    +86-021-64175590 ext 82420    miaochh@aliyun.com   
Contact: Xuqin Zhu    +86-021-64175590 ext 82420    zhuxuqin1101@sina.com   
Fudan University Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Jing Cang    +86-139-1601-0421    cangjing1998@aliyun.com   
Fudan University Huashan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Yingwei Wang    +86-139-1869-0528    wangyingwei@yahoo.com   
Sponsors and Collaborators
Fudan University
Washington University School of Medicine
Investigators
Principal Investigator: Changhong Miao Fudan University
Study Director: Qianjin Liu Washington University School of Medicine

Responsible Party: Changhong Miao, Director of Anesthesiology Department of Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT03659292     History of Changes
Other Study ID Numbers: FDUSCCA-2
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Changhong Miao, Fudan University:
Epidural block
Pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs