Clinical trial NCT04232670: Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Official title: Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Duct Stone
Pancreatic Duct Stricture
Pancreatic Duct Dilatation
Keywords: pancreas
pancreatic duct
ductal stone
duct stricture
ERCP
pancreatic duct obstruction
duct calcification
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a single center, pilot, sham-controlled clinical trial of ERCP with pancreatic endotherapy for pain secondary to chronic calcific pancreatitis with main pancreatic duct obstruction. Potential subjects will undergo a comprehensive baseline assessment including Quantitative Sensory Testing, to ensure enrollment criteria are met and baseline covariates are measured. Eligible subjects will complete a 14-day run-in period. If eligibility criteria persist, subjects will be randomized to diagnostic endoscopic ultrasound (EUS) + sham pancreatic endotherapy or diagnostic EUS + ERCP with pancreatic endotherapy as defined in the study protocol. Subjects will be followed by a blinded physician for the next 90 days, at which time the pilot trial outcomes will be measured. Regardless of outcomes, all subjects will be followed longitudinally for 12 months after randomization.

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

Primary outcomes:
measure: Average daily pain: Numeric Rating Scale (NRS)
timeFrame: Day -14 to Day 90
Secondary outcomes:
measure: Change from baseline in pain severity and functional impairment
timeFrame: Baseline to Day 90
measure: Quality of Life: Using the PROMIS 29 instrument
timeFrame: Baseline to Day 90
measure: Opioid Misuse
timeFrame: Baseline to Day 90
measure: Pain Catastrophizing
timeFrame: Baseline to Day 90
measure: Mechanical pain threshold
timeFrame: Baseline to Day 90
measure: Pain tolerance: Quantitative Sensory Testing
timeFrame: Baseline to Day 90
measure: Pain wind up
timeFrame: Baseline to Day 90
measure: Conditioned pain modulation
timeFrame: Baseline to Day 90
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Oregon Health and Science University
name: Gregory Cote, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: