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NCT02399800 · ClinicalTrials.gov registry record · NA
Celiac Plexus Block for Chronic Pancreatitis RCT
A NA study, sponsored by University of Southern California.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02399800 is a NA study that was terminated before completion, run by University of Southern California. The registered enrollment target is 1 participants.
The verdict
NCT02399800, a NA study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Celiac Block with triamcinolone and bupivicaine
- PROCEDURE No Celiac Block
- DRUG Intra Plexus Triamcinolone and Bupivicaine Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-02-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02399800
The ClinicalTrials.gov registry entry for NCT02399800 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Celiac Block with triamcinolone and bupivicaine is the first listed.
NCT02399800 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02399800 about?
NCT02399800 is a clinical study titled "Celiac Plexus Block for Chronic Pancreatitis RCT". 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 panc...
What is the current status of trial NCT02399800?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2014-12. Estimated completion is 2018-02-12.
What interventions are being tested in trial NCT02399800?
The interventions under investigation include: Celiac Block with triamcinolone and bupivicaine (PROCEDURE), No Celiac Block (PROCEDURE), Intra Plexus Triamcinolone and Bupivicaine Injection (DRUG).
Who is sponsoring clinical trial NCT02399800?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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