Skip to main content
Clinical Trials/NCT01929915
NCT01929915CompletedNot Applicable

Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial

National Taiwan University Hospital1 site in 1 country135 target enrollmentStarted: July 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
135
Locations
1
Primary Endpoint
Perioperative immunoprofile

Study Overview

Brief Summary

Long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4.

Surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. Release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. Currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is available13. However, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated.

In this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic T-lymphocytes were also investigated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pancreatic cancer expected to receive curative Whipple operation

Exclusion Criteria

  • palliative operation
  • preoperative chemotherapy or radiotherapy
  • patients with metastasis
  • contraindications for epidural catheter placement
  • prior spine surgery

Arms & Interventions

Intravenous patient controlled analgesia

Sham Comparator

Intravenous patient controlled analgesia for post operative pain control

Intervention: Intravenous patient controlled analgesia (Drug)

Epidural patient controlled analgesia

Active Comparator

Epidural patient controlled analgesia

Intervention: Epidural patient controlled analgesia (Procedure)

Outcomes

Primary Outcomes

Perioperative immunoprofile

Time Frame: one week

Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells

Secondary Outcomes

  • survival rate(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials