Pancreatic Endotherapy for Refractory Chronic Pancreatitis

Pancreatic Endotherapy for Refractory Chronic Pancreatitis

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.

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