Clinical trial NCT01929915: Analgesia and Pancreatic Cancer Surgery
Official title: Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Perioperative immunoprofile
timeFrame: one week
Secondary outcomes:
measure: survival rate
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, NTUH, Taipei, Taiwan
Study officials:
affiliation: Department of Anesthesiology, NTUH, Taipei, Taiwan
name: Kuang Cheng Chan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cummings KC 3rd, Xu F, Cummings LC, Cooper GS. A comparison of epidural analgesia and traditional pain management effects on survival and cancer recurrence after colectomy: a population-based study. Anesthesiology. 2012 Apr;116(4):797-806. doi: 10.1097/ALN.0b013e31824674f6.