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Analgesia and Pancreatic Cancer Surgery

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Epidural patient controlled analgesia
Intravenous patient controlled analgesia
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, NTUH, Taipei, Taiwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Epidural patient controlled analgesia

Intravenous patient controlled analgesia

Arm Description

Epidural patient controlled analgesia

Intravenous patient controlled analgesia for post operative pain control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

survival rate

Full Information

First Posted
July 18, 2013
Last Updated
May 6, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01929915
Brief Title
Analgesia and Pancreatic Cancer Surgery
Official Title
Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural patient controlled analgesia
Arm Type
Active Comparator
Arm Description
Epidural patient controlled analgesia
Arm Title
Intravenous patient controlled analgesia
Arm Type
Sham Comparator
Arm Description
Intravenous patient controlled analgesia for post operative pain control
Intervention Type
Procedure
Intervention Name(s)
Epidural patient controlled analgesia
Other Intervention Name(s)
Fentanyl, marcaine(bupivacaine hydrochloride)
Intervention Description
Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control
Intervention Type
Drug
Intervention Name(s)
Intravenous patient controlled analgesia
Other Intervention Name(s)
morphine
Intervention Description
Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control
Primary Outcome Measure Information:
Title
Perioperative immunoprofile
Description
Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells
Time Frame
one week
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang Cheng Chan, M.D.
Organizational Affiliation
Department of Anesthesiology, NTUH, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, NTUH, Taipei, Taiwan
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22273991
Citation
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.
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Analgesia and Pancreatic Cancer Surgery

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