Analgesia and Pancreatic Cancer Surgery

NCT01929915 | Completed DMC

• 1 other identifier: 201203094RIC
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Perioperative immunoprofile

  Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells

  one week

Secondary Outcomes (1)

• survival rate

  one year

Study Arms (2)

Epidural patient controlled analgesia

ACTIVE COMPARATOR

Epidural patient controlled analgesia

Procedure: Epidural patient controlled analgesia

Intravenous patient controlled analgesia

SHAM COMPARATOR

Intravenous patient controlled analgesia for post operative pain control

Drug: Intravenous patient controlled analgesia

Interventions

Epidural patient controlled analgesia PROCEDURE

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

Also known as: Fentanyl, marcaine(bupivacaine hydrochloride)

Epidural patient controlled analgesia

Intravenous patient controlled analgesia DRUG

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

Also known as: morphine

Intravenous patient controlled analgesia

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatic cancer expected to receive curative Whipple operation

You may not qualify if:

• palliative operation
• preoperative chemotherapy or radiotherapy
• patients with metastasis
• contraindications for epidural catheter placement
• prior spine surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan

Taipei, 10002, Taiwan

Location

Related 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.

  PMID: 22273991 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fentanyl; Analgesia, Patient-Controlled; Morphine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kuang Cheng Chan, M.D.

  Department of Anesthesiology, NTUH, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: August 28, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 11, 2022

Record last verified: 2022-04

Locations

TW (1)