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Clinical Trials/NCT04403074
NCT04403074
Recruiting
N/A

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

Indiana University1 site in 1 country35 target enrollmentOctober 20, 2017

Overview

Phase
N/A
Intervention
Celiac Plexus Neurolysis
Conditions
Chronic Pancreatitis
Sponsor
Indiana University
Enrollment
35
Locations
1
Primary Endpoint
Dosage of pain medication
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2017
End Date
October 20, 2029
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammad Al-Haddad

Associate Professor of Medicine, Associate Clinical Director

Indiana University

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

Arms & Interventions

Chronic Pancreatitis Patients

Patients that have Chronic Pancreatitis and the current treatment with Celiac Plexus Blocks (CPB) are providing minimal relief of pain (CPB provide less than one month of pain relief). These patient will then receive a Celiac Plexus Neurolysis.

Intervention: Celiac Plexus Neurolysis

Outcomes

Primary Outcomes

Dosage of pain medication

Time Frame: Immediately post procedure and weekly up to 24 weeks

Compare dose of pain medication post procedure \& weekly for up to 24 weeks after converting all to morphine equivalents

Use of Pain medication

Time Frame: Immediately post procedure & weekly up to 24 weeks

Use of pain medication (by using morphine equivalents) for each patient will be tracked weekly for up to 24 weeks post CPN to track pain management/relief for the of patients. There should be a lessening in use of pain medication as time progesses.

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

Compare weekly pain intensity score for pain management/relief of patients.

Study Sites (1)

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