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NCT Number: NCT06178315

EUS-guided Celiac Plexus Block vs. Sham 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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EUS-guided celiac plexus block

Procedure

Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.

Sham Procedure

Procedure

Celiac plexus will not be performed in this arm.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Technical success

    Time frame: Immediately after procedure

    Successful completion of EUS-CPB.

  2. Pain scores measured using Visual Analog Scale.

    Time frame: 3 months

    Pain score measured using the Visual Analog Scale.

  3. Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.

    Time frame: 3 months

    Pain score measured using the Comprehensive Pain Assessment Tool-Short Form.

  4. Quality of life assessment

    Time frame: 3 months

    Quality of life score measured using the Pancreatitis Quality of Life Instrument.

  5. Opioid analgesic use

    Time frame: 3 months

    Opioid analgesic use measured in morphine equivalent dosage.

  6. Procedure-related adverse events

    Time frame: 3 months

    Any adverse event occurring as a result of endoscopic intervention.

  7. Disease-related adverse events

    Time frame: 3 months

    Any adverse event occurring as a result of underlying chronic pancreatitis.

  8. Hospital admissions for management of chronic pancreatitis.

    Time frame: 3 months

    Number of hospital admissions for management of chronic pancreatitis.

  9. Length of hospitalization in any patient hospitalized

    Time frame: 3 months

    Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis.

  10. Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.

    Time frame: 3 months

    Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.

  11. Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.

    Time frame: 3 months

    Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara J Broome

CONTACT

[email protected]

321-841-7031

Charles Melbern Wilcox, MD

CONTACT

[email protected]

321-841-2431

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis

Acronym: EPOCH

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 21, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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