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Analgesia and Pancreatic Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: July 18, 2013
Last updated: July 14, 2015
Last verified: July 2015

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

Secondary Outcome Measures:
  • survival rate [ Time Frame: one year ]

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


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  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 identifier: NCT01929915

Contact: Kuang Cheng Chan, M.D. 886-2-23123456 ext 62158

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

Responsible Party: National Taiwan University Hospital Identifier: NCT01929915     History of Changes
Other Study ID Numbers: 201203094RIC
Study First Received: July 18, 2013
Last Updated: July 14, 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local processed this record on May 23, 2017