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Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04025840
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Surgery Epidural Block Dexamethasone Overall Survival Other: Epidural block Drug: Dexamethasone Phase 4

Detailed Description:

Pancreatic cancer is the fourth leading cause of cancer-related death in the world, and is estimated to become the second one in 2030. For patients with resectable pancreatic cancer, radical surgery is the first-line therapy. However, the clinical outcomes remain poor even after radical resection, as the incidence of postoperative morbidity is up to 50% and the 5-year survival rate remains below 30%.

For patients undergoing major intraabdominal surgery, epidural block may provide advantages by blocking the afferent nociceptive stimuli, providing better pain relief, decreasing opioid consumption, and alleviating stress response. These effects may be helpful in preserving immune function. Some retrospective studies showed that epidural block is associated with delayed cancer recurrence/metastasis and improved survival after cancer surgery.

Low-dose dexamethasone is frequently used to prevent postoperative nausea and vomiting. Recent evidences from retrospective studies suggest that perioperative dexamethasone may also affect long-term outcome after cancer surgery. For example, in patients undergoing lung cancer surgery, intraoperative dexamethasone is associated with improved recurrence-free and overall survival. Similar results are also reported in patients after pancreatic cancer surgery.

The investigators hypothesize that perioperative epidural block and dexamethasone may improve survival in patients after radical pancreatic surgery. The purpose of this study is to investigate whether perioperative epidural block and/or dexamethasone can improve 2-year survival in patients after pancreatic cancer surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2×2 factorial trial
Masking: Single (Outcomes Assessor)
Masking Description: For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.
Primary Purpose: Supportive Care
Official Title: Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2026


Arm Intervention/treatment
No Intervention: Control
Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
Experimental: Epidural block
Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.
Other: Epidural block
Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
Other Name: Epidural anesthesia/analgesia

Experimental: Dexamethasone
Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
Drug: Dexamethasone
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
Other Name: Glucocorticoids

Experimental: Epidural block+Dexamethasone
Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.
Other: Epidural block
Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
Other Name: Epidural anesthesia/analgesia

Drug: Dexamethasone
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
Other Name: Glucocorticoids




Primary Outcome Measures :
  1. 2-year overall survival [ Time Frame: Up to 2 years after surgery. ]
    2-year overall survival


Secondary Outcome Measures :
  1. Postoperative gastrointestinal complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of postoperative gastrointestinal complications.

  2. Overall postoperative complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of overall postoperative complications.

  3. Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.

  4. All-cause 30-day mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of all-cause 30-day mortality.

  5. Quality of life in 1- and 2-year survivors. [ Time Frame: At the end of the first and second year after surgery. ]
    Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ)-PAN26. It is a 26-item questionnaire that evaluates 9 symptoms and 5 emotional difficulties related to pancreatic cancer. Each item is scaled 0-100. High scores indicate worse symptoms and poorer quality of life.

  6. Hospital readmission within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Rate of hospital readmission within 2 years after surgery.

  7. 2-year progression-free survival [ Time Frame: Up to 2 years after surgery. ]
    Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.


Other Outcome Measures:
  1. Subjective sleep quality: Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Subjective sleep quality is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates the best sleep and 10 the worst sleep).

  2. Pain severity (at rest and with movement): Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Pain severity is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates no pain and 10 the worst pain).

  3. Time to ambulation after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to ambulation after surgery.

  4. Time to oral intake after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to oral intake after surgery.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥45 and <90 years;
  2. Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery;
  3. Agreed to receive epidural block and postoperative patient-controlled analgesia;
  4. Agreed to participate in the study and provided written informed consent.

Exclusion Criteria:

  1. Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy;
  2. Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis;
  3. Complicated with primary malignant tumor in other organ(s), either previously or at present;
  4. Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery;
  5. Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases;
  6. Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine >442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V;
  7. Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain;
  8. Other conditions that are considered unsuitable for study participation;
  9. Refused to participate in the study.

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): NCT04025840


Contacts
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Contact: Dong-Xin Wang, MD, PhD 86 (10) 83572784 wangdongxin@hotmail.com
Contact: Zhen-Zhen Xu, MD 86 (10) 83572460 zjxvzhenzhen@126.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    86 (10) 83572784    wangdongxin@hotmail.com   
Contact: Zhen-Zhen Xu, MD    86 (10) 83572460    zjxvzhenzhen@126.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

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Responsible Party: Dong-Xin Wang, Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04025840    
Other Study ID Numbers: 2019-99
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Pancreatic cancer
Radical resection
Epidural block
Dexamethasone
Overall survival
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Dexamethasone
Dexamethasone acetate
Anesthetics
Ropivacaine
Glucocorticoids
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents