Pancreatic Endotherapy for Refractory Chronic Pancreatitis

Oregon Health and Science University14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pancreatic Duct Stone Pancreatic Duct Stricture Pancreatic Duct Dilatation

Interventions

EUS + SHAMPROCEDURE

Endoscopic Ultrasound

EUS + Pancreatic EndotherapyPROCEDURE

Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Percent Change in Average Daily Pain Score on the Numeric Rating Scale

The percent change in average daily pain score from the daily diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. The investigators employed the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.

Time frame: Day -14 to Day 90

Data from ClinicalTrials.gov

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