Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies
Recruitment status was Recruiting
Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the abdominal pain associated with pancreatic malignancy and other conditions, and is usually undertaken at a late stage in the disease process, when analgesic options have been largely exhausted or have led to significant and often unacceptable side effects. Until recently, CPN was most commonly performed under radiographic guidance; however, in the last 10 years, CPN has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case series have demonstrated the efficacy and safety of this technique when used to treat the pain associated with pancreatic malignancy and/or chronic pancreatitis. However, the efficacy of EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be described. The goal of this study is to assess the efficacy of EUS-guided CPN in the management of pain in patients with abdominal non-pancreatic malignancies. Our hypothesis is that EUS-guided CPN will provide adequate pain relief in these patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies|
- Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI) [ Time Frame: 1 month ] [ Designated as safety issue: No ]The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure
- Difference in mean pain scores before and at 1 day after the procedure, 7 days after the procedure, 14 days after the procedure, and at 2 months after the procedure, as determined by the Brief Pain Inventory (BPI). [ Time Frame: 2 months ] [ Designated as safety issue: No ]The BPI will be filled out just prior to the procedure and after the procedure at the above intervals (up to 2 months) to assess the difference in the mean pain scores after the procedure.
- Difference in the mean 'level of interference of pain with daily life' score, as determined by the Brief Pain Inventory (BPI). This score will be determined before and after the procedure, determined at the same intervals as mean pain scores. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed [ Time Frame: 2 months ] [ Designated as safety issue: No ]Names, doses, and quantity of pain medications will be reported and converted to an equianalgesic dose (mg/day) of orally administered morphine. The difference in equianalgesic doses (mg/day) will be determined at the same intervals as mean pain scores.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Procedure: EUS-guided Celiac Plexus Neurolysis
All patients will receive anesthesia. The linear echo-endoscope will be advanced into the proximal stomach. It will be noted whether the tumor is seen in the celiac axis, if there is flow in the celiac artery, and if the celiac ganglia are seen. The celiac ganglia will be injected directly with 10cc of 0.25% bupivicaine followed by 10cc of 98% dehydrated alcohol. If the celiac ganglia cannot be identified, the posterior and anterior aspects of celiac artery take-off will be injected in a similar manner (twice the volume). Flow in the celiac axis will be confirmed. All injections will be performed with a standard EUS injection needle made especially for CPN . Prior to injection, aspiration will be performed through the needle to ensure that no blood is aspirated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166529
|Contact: Raj N Keswani, MD||(312)-email@example.com|
|Contact: David M Shapiro, MD||(312)-firstname.lastname@example.org|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Raj N Keswani, MD 312-695-8174 email@example.com|
|Principal Investigator: Raj N Keswani, MD|
|Sub-Investigator: Mary F Mulcahy, MD|
|Sub-Investigator: David M Shapiro, MD|
|Principal Investigator:||Raj N Keswani, MD||Northwestern University|