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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00968175 |
Purpose
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.
| Condition | Intervention |
|---|---|
|
Pain Pancreatic Cancer |
Procedure: Ultrasound guided celiac plexus neurolysis (CPN) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
| Official Title: | EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Randomized, Single-Blinded Controlled Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1: CPN + analgesic therapy
Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy
|
Procedure: Ultrasound guided celiac plexus neurolysis (CPN)
Initial procedure and rescue procedure if applicable
Other Name: EUS-CPN
|
|
No Intervention: Analgesic therapy alone
Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management
|
The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.
The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shyam Varadarajulu, MD | 205-996-4059 | svaradar@uabmc.edu |
| Contact: Joey Richardson, RN | 205-975-0450 | jhr7526@uab.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Shyam Varadarajulu, MD 205-996-4059 svaradar@uabmc.edu | |
| Contact: Joey Richardson, RN 205-975-0450 jhr7526@uab.edu | |
| Principal Investigator: Shyam Varadarajulu, MD | |
| Principal Investigator: | Shyam Varadarajulu, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | Shyam Varadarajulu , M.D., UAB |
| ClinicalTrials.gov Identifier: | NCT00968175 History of Changes |
| Other Study ID Numbers: | F090528002 |
| Study First Received: | August 26, 2009 |
| Last Updated: | April 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Ultrasound guided celiac plexus neurolysis CPN Pancreatic Cancer Pain Management |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |