Analgesia and Pancreatic Cancer Surgery
Conditions
Pancreatic Neoplasms
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Epidural patient controlled analgesia Type: Procedure
Name: Intravenous patient controlled analgesia Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
Department of Anesthesiology, NTUH, Taipei, Taiwan
Taipei, Taiwan
Status: Recruiting
Contact: Kuang Cheng Chan, M.D. - 886-2-23123456 - jkjchan@gmail.com
Start Date
August 2012
Completion Date
August 2015
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page