Celiac Plexus Block for Chronic Pancreatitis

(EPOCH Trial)

Overseen By Barbara J Broome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orlando Health, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Prior EUS-CPB, Allergy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 month

94 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants (blood thinners) that cannot be stopped for the procedure.

What data supports the effectiveness of the treatment EUS-guided celiac plexus block for chronic pancreatitis?

Research suggests that EUS-guided celiac plexus block can help manage abdominal pain in chronic pancreatitis, with some studies indicating it may be effective for pain relief. However, the effectiveness and safety of repeated procedures and comparisons with other techniques are still being evaluated. ^{1 2 3 4 5}

Is the celiac plexus block generally safe for humans?

Celiac plexus block, often guided by endoscopic ultrasound (EUS), is generally considered safe for managing pain in conditions like chronic pancreatitis and pancreatic cancer. Serious complications are rare, but some people may experience diarrhea, a drop in blood pressure when standing up (orthostatic hypotension), or a temporary increase in abdominal pain. ^{1 2 3 4 6}

How is the EUS-guided celiac plexus block treatment different from other treatments for chronic pancreatitis?

The EUS-guided celiac plexus block is unique because it uses endoscopic ultrasound to precisely target and block nerves in the abdomen that transmit pain signals, offering pain relief for chronic pancreatitis. This method is less invasive than surgery and can be repeated if necessary, but its effectiveness and safety for repeated use are still being studied. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with chronic pancreatitis, experiencing abdominal pain for at least three months. They must have a confirmed diagnosis of chronic pancreatitis via EUS and no other causes for their pain. It's not open to those under 18, anyone who has had this procedure before, pregnant individuals, patients on certain blood thinners or with allergies to specific anesthetics.

Inclusion Criteria

I have had abdominal pain for 3 months or more, with a pain level of 3 or higher.

My chronic pancreatitis diagnosis was confirmed with an EUS showing 5 or more features.

My abdominal pain has no other identified cause.

Exclusion Criteria

I have had a previous EUS-CPB procedure.

I am on blood thinners that can't be stopped for a procedure.

Intrauterine pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EUS-guided celiac plexus block or sham procedure to assess pain relief

1 month

1 visit (in-person)

Follow-up

Participants are monitored for pain relief, quality of life, and adverse events

3 months

Treatment Details

Interventions

• EUS-guided celiac plexus block
• Sham procedure

Trial Overview The study is testing the effectiveness of an EUS-guided celiac plexus block (EUS-CPB) in reducing abdominal pain against a sham (fake) procedure. Participants are randomly assigned to receive either the real treatment or a placebo-like intervention without therapeutic effect.

Participant Groups

Group I: Endoscopic ultrasound-guided celiac plexus block Active Control 1 Intervention

EUS-guided celiac plexus block will be performed.

Group II: Sham Placebo Group 1 Intervention

Celiac plexus block will not be performed.

EUS-guided celiac plexus block is already approved in United States, European Union, Japan for the following indications:

Approved in United States as EUS-CPB for:

• Chronic pancreatitis pain management

Approved in European Union as EUS-CPB for:

• Chronic pancreatitis pain management

Approved in Japan as EUS-CPB for:

• Chronic pancreatitis pain management
• Pancreatic cancer pain management

Who Is Running the Clinical Trial?

Orlando Health, Inc.

Lead Sponsor

Trials

32

Recruited

15,100+

Findings from Research

In a study of 248 patients with chronic pancreatitis who underwent multiple endoscopic ultrasound-guided celiac plexus blocks (EUS-CPB), the procedure was found to be safe, with no major adverse events reported despite some minor complications.

The effectiveness of subsequent EUS-CPB procedures was linked to the response from the first procedure, indicating that patients who experienced pain relief initially were more likely to benefit from additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of serial endoscopic ultrasound-guided celiac plexus block for chronic pancreatitis. Sey, MS., Schmaltz, L., Al-Haddad, MA., et al.[2020]

In a study of 50 patients with chronic pancreatitis, both 1-injection and 2-injection methods of EUS-guided celiac plexus block provided similar pain relief, with no significant difference in duration or onset of relief.

Both injection methods were found to be safe, indicating that either approach can be effectively used for pain management in chronic pancreatitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of 1 versus 2 injections during EUS-guided celiac plexus block for chronic pancreatitis pain. LeBlanc, JK., DeWitt, J., Johnson, C., et al.[2016]

EUS-guided celiac plexus block significantly reduced pain in 55% of the 90 patients with chronic pancreatitis, with mean pain scores dropping from 8 to 2 after the procedure, indicating its efficacy in pain management.

The procedure was found to be safe, with only three patients experiencing temporary diarrhea, and it is also more cost-effective compared to CT-guided techniques, making it a viable option for certain patients with chronic abdominal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided celiac plexus block for managing abdominal pain associated with chronic pancreatitis: a prospective single center experience. Gress, F., Schmitt, C., Sherman, S., et al.[2013]

EUS-guided celiac plexus block (CPB) effectively alleviated chronic abdominal pain in 51.46% of patients with chronic pancreatitis, based on a review of 6 studies involving 221 patients.

EUS-guided celiac plexus neurolysis (CPN) showed a higher efficacy, relieving pain in 72.54% of patients with pancreatic cancer, from 5 studies with 119 patients, making it a viable option for those who can tolerate narcotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of endoscopic ultrasound-guided celiac plexus block and celiac plexus neurolysis for managing abdominal pain associated with chronic pancreatitis and pancreatic cancer. Kaufman, M., Singh, G., Das, S., et al.[2022]

In a study of 56 patients with chronic pancreatitis, EUS-guided coeliac plexus block (EUS-CPB) resulted in significant pain relief for 70% of patients, compared to only 30% for those receiving the conventional percutaneous technique (PCFG-CPB).

The findings suggest that EUS-CPB is a more effective method for managing abdominal pain in chronic pancreatitis, highlighting its potential as a preferred treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: a randomized trial comparing fluoroscopy guided percutaneous technique vs. endoscopic ultrasound guided technique of coeliac plexus block for treatment of pain in chronic pancreatitis. Santosh, D., Lakhtakia, S., Gupta, R., et al.[2013]

EUS-guided celiac plexus block (CPB) and neurolysis (CPN) are effective interventions for managing abdominal pain related to pancreatic diseases, providing pain relief in about 70-80% of patients with pancreatic cancer and 50-60% of those with chronic pancreatitis.

Serious complications from these procedures are rare, with the most common side effects being diarrhea, orthostatic hypotension, and temporary increases in abdominal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Celiac Plexus Interventions. Moutinho-Ribeiro, P., Costa-Moreira, P., Caldeira, A., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of serial endoscopic ultrasound-guided celiac plexus block for chronic pancreatitis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of 1 versus 2 injections during EUS-guided celiac plexus block for chronic pancreatitis pain. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided celiac plexus block for managing abdominal pain associated with chronic pancreatitis: a prospective single center experience. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of endoscopic ultrasound-guided celiac plexus block and celiac plexus neurolysis for managing abdominal pain associated with chronic pancreatitis and pancreatic cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical trial: a randomized trial comparing fluoroscopy guided percutaneous technique vs. endoscopic ultrasound guided technique of coeliac plexus block for treatment of pain in chronic pancreatitis. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Celiac Plexus Interventions. [2021]