Celiac Plexus Block for Chronic Pancreatitis RCT
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|ClinicalTrials.gov Identifier: NCT02399800|
Recruitment Status : Terminated (Low enrollment)
First Posted : March 26, 2015
Last Update Posted : February 14, 2018
Rationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which results in debilitating abdominal pain, decreased productivity and increased health care costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic cancer has significant efficacy, the benefit of CPB for chronic pancreatitis pain is controversial and has not been studied in a rigorous manner.
Objective: To assess whether EUS guided celiac plexus block decreases suffering, hospitalization, and opiate requirements related to chronic pancreatitis pain.
Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic pancreatitis.
Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will be eligible.
Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic ultrasound with celiac plexus block
Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior to the block. The ability to work and conduct normal activities, opiate medication requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to the block.
Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo response in patients with pain related to chronic pancreatitis we anticipate that 83 patients will need to participate to demonstrate a difference. We aim to enroll 90 patients in this study.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Chronic Pancreatitis||Procedure: Celiac Block with triamcinolone and bupivicaine Procedure: No Celiac Block Drug: Intra Plexus Triamcinolone and Bupivicaine Injection||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 12, 2018|
|Actual Study Completion Date :||February 12, 2018|
Experimental: EUS with Celiac Block
Celiac Block with triamcinolone and bupivicaine Intra Plexus Triamcinolone and Bupivicaine Injection
Procedure: Celiac Block with triamcinolone and bupivicaine
Endosonography of the pancreas performed following by analgesic injection
Drug: Intra Plexus Triamcinolone and Bupivicaine Injection
Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief
Other Name: kenalog
Active Comparator: EUS without Celiac Block
Patients will undergo EUS but no celiac block will be performed
Procedure: No Celiac Block
EUS but no celiac block performed
- Long Term CHANGE in Pain Scores [ Time Frame: 24 weeks ]Primary outcomes will be the CHANGE pain score (as assessed by the visual-analogue-scale and M-ANNHEIM score assessed between time 0 and 24 weeks post procedure in those who undergo EUS without block (control) compared to those who undergo EUS with block
- Hospital re-admission [ Time Frame: 24 weeks ]differences in number of hospital re-admissions for pancreatic pain assessed at 24 weeks between those who underwent the block and did not undergo the celiac block
- CHANGE Pain medication requirements [ Time Frame: 24 weeks ]CHANGE in pain medication requirement 24 weeks following celiac block in those who underwent EUS guided celiac block compared to those who did not
- Procedure Complications [ Time Frame: 2 weeks ]Post procedure complications include infection (defined as fever or increased WBC without an alternative cause), diarrhea (defined as 3 loose stools per day), or pancreatitis (defined as increased pain and lipase >3 X the upper limit of normal). Will be assessed 2 weeks after the procedure and compared between those who EUS with block compared to EUS without block
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): NCT02399800
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James Buxbaum, MD||Los Angels County Hospital|