NCT04403074

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
41mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Oct 2017Oct 2029

Study Start

First participant enrolled

October 20, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

12 years

First QC Date

October 10, 2018

Last Update Submit

February 16, 2026

Conditions

Keywords

PancreatitisIndianaBlockCeliacPlexus

Outcome Measures

Primary Outcomes (3)

  • Use of Pain medication

    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.

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

    Immediately post procedure and weekly up to 24 weeks

  • Dosage of pain medication

    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

Study Arms (1)

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.

Procedure: Celiac Plexus Neurolysis

Interventions

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.

Chronic Pancreatitis Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatitisBites and StingsCeliac Disease

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and InjuriesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mo A, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Al-Haddad

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Associate Clinical Director

Study Record Dates

First Submitted

October 10, 2018

First Posted

May 27, 2020

Study Start

October 20, 2017

Primary Completion (Estimated)

October 20, 2029

Study Completion (Estimated)

October 20, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations