- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929915
Analgesia and Pancreatic Cancer Surgery
Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 10002
- Department of Anesthesiology, NTUH, Taipei, Taiwan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Epidural patient controlled analgesia
|
Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for
postoperative pain control
Other Names:
|
SHAM_COMPARATOR: Intravenous patient controlled analgesia
Intravenous patient controlled analgesia for post operative pain control
|
Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative immunoprofile
Time Frame: one week
|
Immunoprofile measurements: CD4+, CD8+, CD19+, NK cells, Dendritic cells, regularoty T cells
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival rate
Time Frame: one year
|
one year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Bupivacaine
- Morphine
Other Study ID Numbers
- 201203094RIC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Neoplasms
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
The First Affiliated Hospital with Nanjing Medical...RecruitingLocally Advanced Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Pancreatic NeoplasmChina
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of OxfordNational Institute for Health Research, United Kingdom; ImunonWithdrawnPancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Stage IV | Pancreatic Cancer Non-resectableUnited Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Pancreatic Carcinoma | Metastatic Pancreatic Carcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic Carcinoma | Pancreatic Neoplasm | Locally Advanced Pancreatic CarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Celgene CorporationCompletedPancreatic Adenocarcinoma | Resectable Pancreatic CarcinomaUnited States
Clinical Trials on Epidural patient controlled analgesia
-
Taipei City HospitalCompletedPain, Postoperative | Epidural Anesthesia | Lumbar Spine Degeneration | Analgesia, Patient-ControlledTaiwan
-
University Hospital OstravaCompletedHip Joint DisordersCzechia
-
Memorial Sloan Kettering Cancer CenterCompletedPostoperative PainUnited States
-
National Taiwan University HospitalUnknown
-
Hospital for Special Surgery, New YorkCompleted
-
Hospital del Río HortegaCompleted
-
Northern State Medical UniversityUniversity of TromsoCompletedCoronary Artery DiseaseRussian Federation
-
Imam Abdulrahman Bin Faisal UniversityUnknownUterine Artery Embolization for Uterine LeiomyomataSaudi Arabia
-
Queen's UniversityCompletedAcute Post-thoracotomy PainCanada
-
Seoul National University HospitalRecruitingPain, Postoperative | Pain ManagementKorea, Republic of