Clinical trial NCT04025840: Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery
Official title: Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pancreatic Cancer
Surgery
Epidural Block
Dexamethasone
Overall Survival
Keywords: Pancreatic cancer
Radical resection
Epidural block
Dexamethasone
Overall survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: The Second Affiliated Hospital of Chongqing Medical University
First posted: 2019-07-19
Enrollment: 260
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2×2 factorial trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: 2-year overall survival
timeFrame: Up to 2 years after surgery.
Secondary outcomes:
measure: Postoperative gastrointestinal complications.
timeFrame: Up to 30 days after surgery.
measure: Overall postoperative complications.
timeFrame: Up to 30 days after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: All-cause 30-day mortality.
timeFrame: Up to 30 days after surgery.
measure: Quality of life in 1- and 2-year survivors.
timeFrame: At the end of the first and second year after surgery.
measure: Hospital readmission within 2 years after surgery.
timeFrame: Up to 2 years after surgery.
measure: 2-year progression-free survival
timeFrame: Up to 2 years after surgery.
Other outcomes:
measure: Subjective sleep quality: Numeric Rating Scale
timeFrame: Between 8-10 am on the first, second, and third days after surgery.
measure: Pain severity (at rest and with movement): Numeric Rating Scale
timeFrame: Between 8-10 am on the first, second, and third days after surgery.
measure: Time to ambulation after surgery.
timeFrame: Up to 30 days after surgery.
measure: Time to oral intake after surgery.
timeFrame: Up to 30 days after surgery.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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