Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

Pancreatic Cancer Clinical Trial

Official title:

Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025840
• Other study ID #: 2019-99
• Status: Recruiting
• Phase: Phase 4
• Start date: September 11, 2019
• Est. completion date: July 2026

Study information

• Verified date: July 2021
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD, PhD
• Phone: 86 (10) 83572784
• Email: wangdongxin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexamethasone
• Epidural Block
• Overall Survival
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

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.

Drug:
• Dexamethasone
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Cancer Hospital, The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective sleep quality: Numeric Rating Scale	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).	Between 8-10 am on the first, second, and third days after surgery.
Other	Pain severity (at rest and with movement): Numeric Rating Scale	Pain severity is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates no pain and 10 the worst pain).	Between 8-10 am on the first, second, and third days after surgery.
Other	Time to ambulation after surgery.	Time to ambulation after surgery.	Up to 30 days after surgery.
Other	Time to oral intake after surgery.	Time to oral intake after surgery.	Up to 30 days after surgery.
Primary	2-year overall survival	2-year overall survival	Up to 2 years after surgery.
Secondary	Postoperative gastrointestinal complications.	Rate of postoperative gastrointestinal complications.	Up to 30 days after surgery.
Secondary	Overall postoperative complications.	Rate of overall postoperative complications.	Up to 30 days after surgery.
Secondary	Length of stay in hospital after surgery.	Length of stay in hospital after surgery.	Up to 30 days after surgery.
Secondary	All-cause 30-day mortality.	Rate of all-cause 30-day mortality.	Up to 30 days after surgery.
Secondary	Quality of life in 1- and 2-year survivors.	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.	At the end of the first and second year after surgery.
Secondary	Hospital readmission within 2 years after surgery.	Rate of hospital readmission within 2 years after surgery.	Up to 2 years after surgery.
Secondary	2-year progression-free survival	Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.	Up to 2 years after surgery.