Analgesia and Pancreatic Cancer Surgery

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Procedure: Epidural patient controlled analgesia; Drug: Intravenous patient controlled analgesia

• Registration Number: NCT01929915
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-28
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural patient controlled analgesia	Epidural patient controlled analgesia	Epidural patient controlled analgesia
Intravenous patient controlled analgesia	Intravenous patient controlled analgesia	Intravenous patient controlled analgesia for post operative pain control

Primary Outcome Measures

Name	Time	Method
Perioperative immunoprofile	one week	Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells

Secondary Outcome Measures

Name	Time	Method
survival rate	one year

Trial Locations

Locations (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan; 🇨🇳 Taipei, Taiwan