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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called EUS-guided celiac plexus block to determine its effectiveness in reducing abdominal pain for individuals with chronic pancreatitis, a condition characterized by long-term inflammation of the pancreas. The trial includes two groups: one receives the actual treatment, while the other undergoes a sham (fake) procedure for comparison. It suits individuals who have experienced pancreas-related abdominal pain for at least three months without other known causes. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially find relief from chronic pain.

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 prior data suggests that this technique is safe for alleviating abdominal pain in chronic pancreatitis?

Research has shown that the EUS-guided celiac plexus block (EUS-CPB) is generally safe for relieving pain in some people with chronic pancreatitis. One study found this procedure to be safe, effective, and cost-efficient for managing pain in these patients. Although the level of pain relief varies among individuals, the procedure consistently demonstrates good safety. The available data report no major safety issues, making it a promising option for those considering participation in related trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EUS-guided celiac plexus block for chronic pancreatitis because it offers a targeted approach to pain management. Unlike traditional treatments, which often include pain medications or surgery, this technique directly targets the nerve cluster responsible for transmitting pain signals from the pancreas. By using endoscopic ultrasound guidance, the procedure is minimally invasive and precise, potentially reducing complications and recovery time. This innovative method could provide faster and more effective relief for patients suffering from chronic pancreatitis.

What evidence suggests that this trial's treatments could be effective for chronic pancreatitis?

Research shows that endoscopic ultrasound-guided celiac plexus block (EUS-CPB), a procedure participants in this trial may receive, can help reduce abdominal pain in people with chronic pancreatitis. Studies have found that this treatment provides pain relief for about 51% to 53% of patients, with relief lasting on average for about three months. However, some researchers believe the treatment could be improved for better efficacy. This trial will compare EUS-CPB with a sham procedure to evaluate its effectiveness across different individuals. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19826273/

Efficacy of endoscopic ultrasound-guided celiac plexus ... Conclusions: EUS-guided CPB was 51.46% effective in managing chronic abdominal pain in patients with chronic pancreatitis, but warrants improvement in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1424390325005800?dgcid=rss_sd_all

Endoscopic Ultrasound–Guided Celiac Plexus Block for ... The efficacy of endoscopic ultrasound-guided celiac plexus block (EUS-CPB) for treatment of pain in chronic pancreatitis (CP) is unclear.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40813224/

Endoscopic ultrasound-guided celiac plexus block for ... EUS-CPB provides pain relief in 53% of patients with painful CP and the effect lasts on average for 3 months. A sham-controlled clinical ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08478-y

Effect of endoscopic ultrasound guided celiac plexus block on ... The primary aim of the study is to evaluate the efficacy of EUS-CPB on relief of abdominal pain in patients with chronic pancreatitis in ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/15360288.2025.2479481

A Systematic Review and Meta-Analysis of The Efficacy ... Our meta-analysis focused on evaluating the efficacy of endoscopic ultrasound-guided celiac plexus blocks (EUS-CPB) in managing pain associated with chronic ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11232683/

Endoscopic ultrasound-guided celiac plexus block for ... Conclusions: EUS-guided celiac plexus block appears to be safe, effective, and economical for controlling pain in some patients with chronic pancreatitis.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06178315

NCT06178315 | EUS-guided Celiac Plexus Block vs. Sham ... 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.