- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04403074
Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis (CPN)
Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohammad Al-Haddad
- Phone Number: 3179440980
- Email: moalhadd@iu.edu
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Hospital
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Contact:
- Mohammad Al-Haddad
- Phone Number: 3179440980
- Email: moalhadd@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
|
Compare weekly pain intensity score for pain management/relief of patients.
|
Immediately post procedure and weekly up to 24 weeks
|
|
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
|
Immediately post procedure and weekly up to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mo A, MD, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Pancreatic Diseases
- Chemically-Induced Disorders
- Malabsorption Syndromes
- Poisoning
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Pancreatitis
- Pancreatitis, Chronic
- Bites and Stings
- Celiac Disease
Other Study ID Numbers
- 1708591420
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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