Celiac Plexus Block for Chronic Pancreatitis

(EPOCH Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Orlando Health, Inc.

Must not be taking: Anticoagulants

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

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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 am 18 years old or older.

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.

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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Orlando Health Orlando, FL

Who Is Running the Clinical Trial?

Orlando Health, Inc. Lead Sponsor

References

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

Effectiveness and safety of serial endoscopic ultrasound-guided celiac plexus block for chronic pancreatitis. [2020] Endoscopic ultrasound - guided celiac plexus block (EUS-CPB) is an established treatment for pain in patients with chronic pancreatitis (CP), but the effectiveness and safety of repeated procedures are unknown. Our objective is to report our experience of repeated EUS-CPB procedures within a single patient.

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] The efficacy of 1-injection versus a 2-injections method of EUS-guided celiac plexus block (EUS-CPB) in patients with chronic pancreatitis is not known.

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] In our previous randomized trial, we suggested a possible role for endoscopic ultrasound (EUS) guided celiac plexus block in the treatment of abdominal pain associated with chronic pancreatitis. The purpose of this study was to evaluate our prospective experience with EUS-guided celiac plexus block for controlling pain attributed to chronic pancreatitis, including follow-up on response rates and complications.

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] Endoscopic ultrasound (EUS)-guided celiac plexus block (CPB) and celiac plexus neurolysis (CPN) have become important interventions in the management of pain due to chronic pancreatitis and pancreatic cancer. However, only a few well-structured studies have been performed to evaluate their efficacy. Given limited data, their use remains controversial. Herein, we evaluate the efficacy of EUS-guided CPB and CPN in alleviating chronic abdominal pain due to chronic pancreatitis and pancreatic cancer respectively.

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] Coeliac plexus block (CPB) is a management option for pain control in chronic pancreatitis. CPB is conventionally performed by percutaneous technique with fluoroscopic guidance (PCFG). Endoscopic ultrasound (EUS) is increasingly used for CPB as it offers a better visualization of the plexus. There are limited data comparing the two modalities.

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

Endoscopic Ultrasound-Guided Celiac Plexus Interventions. [2021] Abdominal pain related to pancreatic disease is often extremely disabling. Endoscopic ultrasound (EUS)-guided celiac plexus block (CPB) is used to control pain associated with chronic pancreatitis. EUS-guided celiac plexus neurolysis (CPN) is typically used to reduce pain associated with pancreatic cancer and can be considered early at the time of diagnosis of inoperable disease. EUS-guided celiac plexus interventions have been shown to be significantly effective in pancreatic pain relief, which is achieved in approximately 70-80% of patients with pancreatic cancer and in 50-60% of those with chronic pancreatitis. Serious complications from CPB and CPN are rare. Most frequent adverse events are diarrhoea, orthostatic hypotension, and a transient increase in abdominal pain. In this article, the Portuguese Group for Ultrasound in Gastroenterology (GRUPUGE) presents an updated perspective of the potential role of EUS-guided celiac plexus interventions, addressing the selection criteria and technical issues of different techniques and analysing recent data on their safety and efficacy.