Analgesia and Pancreatic Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01929915
First received: July 18, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pancreatic Neoplasms
Procedure: Epidural patient controlled analgesia
Drug: Intravenous patient controlled analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Perioperative immunoprofile [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells


Secondary Outcome Measures:
  • survival rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epidural patient controlled analgesia
Epidural patient controlled analgesia
Procedure: Epidural patient controlled analgesia
Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control
Other Names:
  • Fentanyl
  • marcaine(bupivacaine hydrochloride)
Sham Comparator: Intravenous patient controlled analgesia
Intravenous patient controlled analgesia for post operative pain control
Drug: Intravenous patient controlled analgesia
Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control
Other Name: morphine

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929915

Contacts
Contact: Kuang Cheng Chan, M.D. 886-2-23123456 ext 62158 jkjchan@gmail.com

Locations
Taiwan
Department of Anesthesiology, NTUH, Taipei, Taiwan Recruiting
Taipei, Taiwan, 10002
Contact: Kuang Cheng Chan, M.D.    886-2-23123456 ext 62158    jkjchan@gmail.com   
Principal Investigator: Kuang Cheng Chan, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kuang Cheng Chan, M.D. Department of Anesthesiology, NTUH, Taipei, Taiwan
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01929915     History of Changes
Other Study ID Numbers: 201203094RIC
Study First Received: July 18, 2013
Last Updated: May 27, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 26, 2014