Analgesia and Pancreatic Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT01929915|
Recruitment Status : Unknown
Verified July 2015 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : August 28, 2013
Last Update Posted : July 16, 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 or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Procedure: Epidural patient controlled analgesia Drug: Intravenous patient controlled analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
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
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
- Perioperative immunoprofile [ Time Frame: one week ]Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells
- survival rate [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929915
|Contact: Kuang Cheng Chan, M.D.||886-2-23123456 ext email@example.com|
|Department of Anesthesiology, NTUH, Taipei, Taiwan||Recruiting|
|Taipei, Taiwan, 10002|
|Contact: Kuang Cheng Chan, M.D. 886-2-23123456 ext 62158 firstname.lastname@example.org|
|Principal Investigator: Kuang Cheng Chan, M.D.|
|Principal Investigator:||Kuang Cheng Chan, M.D.||Department of Anesthesiology, NTUH, Taipei, Taiwan|