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Analgesia and Pancreatic Cancer Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01929915
Enrollment
135
Registered
2013-08-28
Start date
2013-07-31
Completion date
2015-04-30
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

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.

Interventions

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

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative immunoprofileone weekImmunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells

Secondary

MeasureTime frame
survival rateone year

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026