Pancreatic Endotherapy for Refractory Chronic Pancreatitis (PERCePT)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Pancreatic Duct Dilatation; Pancreatic Duct Stone; Pancreatic Duct Stricture

Treatments: Procedure: EUS + SHAM; Procedure: EUS + Pancreatic Endotherapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04232670

Pro00087299

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

EUS + SHAM

Sham Comparator group

Description:

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).

Treatment:

Procedure: EUS + SHAM

EUS + Pancreatic Endotherapy

Experimental group

Description:

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.

Treatment:

Procedure: EUS + Pancreatic Endotherapy