N/A
N=14
Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Pancreatic Duct Stone · Pancreatic Duct Stricture · Pancreatic Duct Dilatation
Bottom Line
View on ClinicalTrials.gov: NCT04232670 ↗Enrolled (actual)
14
Serious AEs
71.4%
Results posted
Sep 2025
Primary outcome: Primary: Percent Change in Average Daily Pain Score on the Numeric Rating Scale — -36.6; -53.7 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EUS + SHAM (Procedure); EUS + Pancreatic Endotherapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Average Daily Pain Score on the Numeric Rating Scale |
-36.6; -53.7 | — |
Summary
The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Main pancreatic duct obstruction, defined by the presence of one or both of the following features:
- Main pancreatic duct calcification with upstream main duct dilation ≥6mm.
- Main pancreatic duct stricture, defined by the presence of main pancreatic duct narrowing with upstream main duct dilation ≥6mm.
- Baseline average abdominal pain score ≥4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale
- Ability to provide written, informed consent
Exclusion Criteria
- Symptoms attributable to a pancreatic pseudocyst or walled off necrosis
- Clinical suspicion of pancreatobiliary malignancy*
- Low probability of follow-up to complete study objectives
- Pregnancy or incarceration
- Medical comorbidities that contraindicate the performance of ERCP
- Previous pancreatic endotherapy
- Current Opioid Misuse Measure score ≥9
- Does not have access to a mobile phone * Pancreatobiliary malignancy
Data sourced from ClinicalTrials.gov (NCT04232670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.