Pancreatic Endotherapy for Refractory Chronic Pancreatitis (PERCePT)
Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
About this trial
This is an interventional treatment trial for Pancreatic Duct Stone focused on measuring pancreas, pancreatic duct, ductal stone, duct stricture, ERCP, pancreatic duct obstruction, duct calcification
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
Sites / Locations
- Oregon Health & Science UniversityRecruiting
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
EUS + SHAM
EUS + Pancreatic Endotherapy
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). 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. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.