N/A N=5 Randomized Single-blind Treatment

CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

Chronic Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT02054910 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Change in Pain Response Over a 6 Month Period of Time Using the VAS Score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Celiac Plexus Block (Procedure); Sham (Procedure)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Response Over a 6 Month Period of Time Using the VAS Score	—	—
SECONDARY Mean Quality of Life Score Between Each Group at 6 Months	—	—
SECONDARY Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline	—	—
SECONDARY Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.	—	—
SECONDARY Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure	—	—
SECONDARY % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.	—	—

Summary

This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

Eligibility Criteria

Inclusion Criteria

All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

Exclusion Criteria

Age 1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
Unable to consent
Non-English speaking patients.
Previously undergone CPB
Pregnancy and Breast feeding
Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
Previous pancreatic surgery
Previous pseudocyst drainage
Other documented causes of abdominal pain.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02054910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.