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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06178315
Other study ID # 2103069
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 7, 2023
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source Orlando Health, Inc.
Contact Charles Melbern Wilcox, MD
Phone 321-841-2431
Email Charles.Wilcox@orlandohealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.


Description:

Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Abdominal pain of at least 3 months duration and a VAS score = 3, with or without the use of narcotic analgesics. - Diagnosis of chronic pancreatitis on EUS examination, with = 5 features on EUS. - No other cause of abdominal pain Exclusion Criteria: - Age < 18 years. - History of prior EUS-CPB. - Use of anticoagulants that cannot be discontinued for the procedure. - Clinically significant allergy to bupivacaine or triamcinolone. - Unable to obtain consent for the procedure from either the patient or LAR. - Intrauterine pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
EUS-guided celiac plexus block
Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
Sham procedure
Celiac plexus will not be performed in this arm.

Locations

Country Name City State
United States Orlando Health Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of adequate pain relief Rate of adequate pain relief in patients with chronic pancreatitis undergoing endoscopic ultrasound-guided celiac plexus block or sham procedure. Adequate pain relief is defined as a 50% reduction in composite pain score from baseline, measured using the Brief Pain Inventory-Short Form, at 1 month post-intervention. 1 month
Secondary Technical success Successful completion of EUS-CPB. Immediately after procedure
Secondary Pain scores measured using Visual Analog Scale. Pain score measured using the Visual Analog Scale. 3 months
Secondary Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form. Pain score measured using the Comprehensive Pain Assessment Tool-Short Form. 3 months
Secondary Quality of life assessment Quality of life score measured using the Pancreatitis Quality of Life Instrument. 3 months
Secondary Opioid analgesic use Opioid analgesic use measured in morphine equivalent dosage. 3 months
Secondary Procedure-related adverse events Any adverse event occurring as a result of endoscopic intervention. 3 months
Secondary Disease-related adverse events Any adverse event occurring as a result of underlying chronic pancreatitis. 3 months
Secondary Hospital admissions for management of chronic pancreatitis. Number of hospital admissions for management of chronic pancreatitis. 3 months
Secondary Length of hospitalization in any patient hospitalized Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis. 3 months
Secondary Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. 3 months
Secondary Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. 3 months
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