Analgesia and Pancreatic Cancer Surgery

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929915
• Other study ID #: 201203094RIC
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Procedure:
• Epidural patient controlled analgesia
Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control

Drug:
• Intravenous patient controlled analgesia
Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, NTUH, Taipei, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative immunoprofile	Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells	one week
Secondary	survival rate		one year