Health TrialsbyHealthPanel

EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis

ConditionChronic Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrlando Health, Inc.

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EUS-guided celiac plexus block

    Procedure/Surgery

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

  • Sham procedure

    Procedure/Surgery

    Celiac plexus will not be performed in this arm.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Endoscopic ultrasound-guided celiac plexus blockActive comparator 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month

Secondary outcomes

1

Technical success

Successful completion of EUS-CPB.

Time frame
Immediately after procedure
2

Pain scores measured using Visual Analog Scale.

Pain score measured using the Visual Analog Scale.

Time frame
3 months
3

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

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

Time frame
3 months
4

Quality of life assessment

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orlando Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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