Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT04025840
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.
This study is active but is not currently recruiting participants.
Notify Me45 year–90 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Epidural anesthesia/analgesia
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
Other names: Glucocorticoids
Time frame: Up to 2 years after surgery.
2-year overall survival
Time frame: Up to 30 days after surgery.
Rate of postoperative gastrointestinal complications.
Time frame: Up to 30 days after surgery.
Rate of overall postoperative complications.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Rate of all-cause 30-day mortality.
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.
Time frame: Up to 2 years after surgery.
Rate of hospital readmission within 2 years after surgery.
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.
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).
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).
Time frame: Up to 30 days after surgery.
Time to ambulation after surgery.
Time frame: Up to 30 days after surgery.
Time to oral intake after surgery.
Peking University First Hospital
Other
Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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