Chronic PancreatitisEPOCHNCT06178315
EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
A study testing EUS-guided celiac plexus block in people with Chronic Pancreatitis, run by Orlando Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- EUS-guided celiac plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Charles Melbern Wilcox, MD, 321-841-2431, charles.wilcox@orlandohealth.com
Barbara J Broome, 321-841-7031, barbara.broome@orlandohealth.com
About this study
Official title: Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- EUS-guided celiac plexus block, Sham procedure
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided celiac plexus blockProcedure or surgery
Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
Sham procedureProcedure or surgery
Celiac plexus will not be performed in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ultrasound-guided celiac plexus block | Active comparator | EUS-guided celiac plexus block will be performed. Receives: Procedure: EUS-guided celiac plexus block |
| Sham | Sham comparator | Celiac plexus block will not be performed. Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (11)
Technical success
Successful completion of EUS-CPB.
Measured: Immediately after procedure
Pain scores measured using Visual Analog Scale.
Pain score measured using the Visual Analog Scale.
Measured: 3 months
Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.
Pain score measured using the Comprehensive Pain Assessment Tool-Short Form.
Measured: 3 months
Quality of life assessment
Quality of life score measured using the Pancreatitis Quality of Life Instrument.
Measured: 3 months
Opioid analgesic use
Opioid analgesic use measured in morphine equivalent dosage.
Measured: 3 months
Procedure-related adverse events
Any adverse event occurring as a result of endoscopic intervention.
Measured: 3 months
Disease-related adverse events
Any adverse event occurring as a result of underlying chronic pancreatitis.
Measured: 3 months
Hospital admissions for management of chronic pancreatitis.
Number of hospital admissions for management of chronic pancreatitis.
Measured: 3 months
Length of hospitalization in any patient hospitalized
Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start7 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178315
- Sponsor's protocol ID
- 2103069
- Acronym
- EPOCH
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 14;25(1):676. doi: 10.1186/s13063-024-08478-y.
PubMed 39396987
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT06178315
- Acronym / sponsor ID
- EPOCH / 2103069
- Conditions
- Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ultrasound-guided celiac plexus block | Active comparator | Procedure: EUS-guided celiac plexus blockEUS-guided celiac plexus block will be performed. |
| Sham | Sham comparator | Procedure: Sham procedureCeliac plexus block will not be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided celiac plexus blockUnder EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus. | Procedure or surgery | Endoscopic ultrasound-guided celiac plexus block |
| Sham procedureCeliac plexus will not be performed in this arm. | Procedure or surgery | Sham |
Primary outcome
Rate of adequate pain relief
Time frame: 1 month
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 39396987Wilcox 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 14;25(1):676. doi: 10.1186/s13063-024-08478-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided celiac plexus block in people with Chronic Pancreatitis, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Melbern Wilcox, MD (321-841-2431, Charles.Wilcox@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adequate pain relief (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.