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Recruiting NCT04403074

Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis

Observational Chronic Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Celiac Plexus Neurolysis.
Who it may be relevant to
Registry conditions: Chronic Pancreatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository

Overview

Physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.

Detailed description

Chronic pancreatitis is extremely painful and pain management in patients with chronic pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is considered multifactorial. Current treatments for pain control primarily include narcotic \& opioid administration; however, these medications require titration of dosage for optimal pain control and are frequently followed by adverse effects such as constipation, nausea or drug addiction. Currently, the FDA has imposed strict regulations regarding the amount, frequency \& length of time patients may receive these medications. With tightly controlled regulations for prescribing narcotics and opioids for chronic pain management, the epidemic of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus block and celiac plexus neurolysis performed under EUS guidance have been employed for pain control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the celiac plexus or ganglia.

This study will focus on collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management.

Interventions

  • Procedure Celiac Plexus Neurolysis
    When CPBs are not effective (less than one month of relief) then a Celiac Plexus Neurolysis may be completed to manage pain associated with Chronic Pancreatitis.

Primary outcome measures

  • Use of Pain medication [Time frame: Immediately post procedure & weekly up to 24 weeks]
  • Patient's pain intensity score (numeric pain rating scale using the visual analogue scale VAS from 1-10) will be assessed weekly (via phone call follow ups) starting right after CPN and continuing for 24 weeks. [Time frame: Immediately post procedure and weekly up to 24 weeks]
  • Dosage of pain medication [Time frame: Immediately post procedure and weekly up to 24 weeks]

Eligibility criteria

Inclusion criteria

  • 18 years of age or older
  • Referral for the treatment of pain related to chronic pancreatitis

Exclusion criteria

  • Less than 18 years of age
  • Absence of chronic pancreatitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Indiana University Hospital — Indianapolis

Identifiers

NCT: NCT04403074 · 1708591420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗