EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EUS-guided celiac plexus block, Sham procedure.
- Who it may be relevant to
- Registry conditions: Chronic Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
Overview
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.
Detailed 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.
Interventions
- 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. - Procedure Sham procedure
Celiac plexus will not be performed in this arm.
Primary outcome measures
- Rate of adequate pain relief [Time frame: 1 month]
Secondary outcome measures (11)
- Technical success [Time frame: Immediately after procedure]
- Pain scores measured using Visual Analog Scale. [Time frame: 3 months]
- Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form. [Time frame: 3 months]
- Quality of life assessment [Time frame: 3 months]
- Opioid analgesic use [Time frame: 3 months]
- Procedure-related adverse events [Time frame: 3 months]
- Disease-related adverse events [Time frame: 3 months]
- Hospital admissions for management of chronic pancreatitis. [Time frame: 3 months]
- Length of hospitalization in any patient hospitalized [Time frame: 3 months]
- Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. [Time frame: 3 months]
- Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Orlando Health — Orlando
Publications
- Wilcox CM, Bang JY, Buxbaum J, Gardner TB, Hawes R, Kedia P, Mardini SH, Muniraj T, Navaneethan U, Oza VM, Tarnasky P, Thakkar S, Waxman I, Varadarajulu S; US Pancreatic Disease Study Group. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial 1. Trials. 2024 Oct PMID 39396987
Identifiers
NCT: NCT06178315 · 2103069