Clinical trial NCT04403074: Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis
Official title: Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Keywords: Pancreatitis
Indiana
Block
Celiac
Plexus
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As long as patients fall under the inclusion criteria and do not fall under exclusions, every patient can be considered. Patient must be declared safe to undergo procedure on individual basis from an evaluation from head doctor on study.

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.

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

Primary outcomes:
measure: Use of Pain medication
timeFrame: Immediately post procedure & weekly up to 24 weeks
measure: 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.
timeFrame: Immediately post procedure and weekly up to 24 weeks
measure: Dosage of pain medication
timeFrame: Immediately post procedure and weekly up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Mo A, MD
role: PRINCIPAL_INVESTIGATOR
References: