ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones

Pancreatic duct stones can cause obstruction of the main pancreatic duct leading to abdominal pain, exocrine pancreatic insufficiency, and recurrent acute pancreatitis. By removing pancreatic duct stones, the obstruction can be relieved, and this can improve symptoms. Small stones can be removed with standard endoscopic retrograde cholangiopancreatography (ERCP) and stone removal, but larger stones may require lithotripsy to break up the stone before removal. The two current methods of lithotripsy include extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL).

ESWL is based on concentrating shock wave energy to the stone through an external device. SOPIL is a newer technique based on direct visualization of the stone during ERCP and targeting the stone with a shock wave catheter. There are currently no studies directly comparing ESWL to SOPIL for breaking apart stones in the pancreatic duct, so this study is designed to compare the two techniques.

Objective #1: Obtain pilot data to determine the optimal method of clearing large MPDS Objective #2: Obtain pilot data to assess how effective large MPDS clearance is in improving long term patient centered outcomes Objective #3: Obtain pilot data to measure the cost effectiveness of large MPDS clearance

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pancreatitis; Pancreatic Duct Stone
• Intervention / Treatment: Procedure: ESWL vs SOPIL

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzette Schmidt, RN; Phone Number: 317-278-0691; Email: suschmid@iu.edu
• Study Contact Backup: Name: Vanessa Patrick; Phone Number: 317-278-0692; Email: vpatrick@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• MPDS located in the head, neck, or neck/body junction of the pancreas
• MPDS > 5 mm in size
• Abdominal CT scan, Endoscopic ultrasound, or prior ERCP demonstrating MPDS
• Abdominal pain related to MPDS
• Previously failed ERCP performed with intent to clear MPDS, OR MPDS determined by treating physicians to not be amenable to clearance by standard ERCP techniques

Exclusion Criteria:

• MPDS predominantly located in the body and tail of pancreas
• Any obstructing MPDS > 5 mm located in the body and tail of pancreas
• Known pancreatic head stricture precluding passage of the pancreatoscope with endoscopic stone extraction based on prior imaging or prior ERCP
• Pancreatic head mass
• Impacted MPDS located at the pancreatic duct orifice
• Prior attempts at ESWL or SOPIL for MPDS
• Walled off pancreatic necrosis
• Active alcohol use, defined as any alcohol use within 2 months
• Surgically altered anatomy (see text)
• Gastric outlet obstruction or obstruction precluding passage of the endoscope
• Standard contraindications to ERCP
• Implanted cardiac pacemakers or defibrillators
• Known calcified aneurysms in the path of the shockwave
• Age < 18 years, pregnancy, incarceration, unwillingness/inability to provide informed consent, or anticipated inability to follow protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESWL; Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones	Procedure: ESWL vs SOPIL; To compare the efficacy of single operator pancreatoscopy (SOP) with intracorporeal lithotripsy (SOPIL) to extracorporeal shock wave lithotripsy (ESWL) for the treatment of main pancreatic duct stones (MPDS) in patients with chronic pancreatitis.
Active Comparator: SOPIL; Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones	Procedure: ESWL vs SOPIL; To compare the efficacy of single operator pancreatoscopy (SOP) with intracorporeal lithotripsy (SOPIL) to extracorporeal shock wave lithotripsy (ESWL) for the treatment of main pancreatic duct stones (MPDS) in patients with chronic pancreatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone	This will be described as a proportion of patients with stone clearance. This is defined by the endoscopist's interpretation of the pancreatogram during the time of ERCP and/or subsequent imaging studies. Two blinded endoscopists will review the final pancreatogram to confirm clearance of MPDS	Up to 24 weeks
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones	Combined lithotripsy and ERCP procedures	Up to 24 weeks
Procedural related adverse events	This will be described as a proportion of patients who develop post-procedure pancreatitis, bleeding, infection, perforation, organ injury, symptomatic hematoma, or Steinstrasse resulting in acute stone impaction at the papilla	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores	Change in Izbicki pain scores from baseline at 3 months, 6 months, 9 months, and 12 months. The Izbicki pain scale is a validated pain score for chronic pancreatitis using a visual analog scale, frequency of pain, requirement of pain medication, and pain affecting functional ability. The score ranges from 0 to 100 with higher scores suggesting more pain.	through study completion, an average of 1 year
Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI	Change in the pancreatitis quality of life instrument (PANQOLI) scores from baseline at 3 months, 6 months, 9 months, and 12 months. The PANQOLI score is a validated quality of life score for chronic pancreatitis with specific focus on the domains of physical function, role function, emotional function, and self-worth. The score ranges from 11 to 103, which higher scores suggesting better quality of life.	through study completion, an average of 1 year
Change in narcotic pain medication usage	Change in daily morphine milligram equivalent usage from baseline at 3 months, 6 months, 9 months, and 12 months	through study completion, an average of 1 year
Change in exocrine insufficiency	This will be described as a proportion of patients who experience weight gain, resolution of steatorrhea, or no longer require pancreatic enzyme supplementation after stone clearance at 3 months, 6 months, 9 months, and 12 months	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean cost of care for stone clearance	Costs will be estimated by procedural fees including the cost of ESWL, lithotripsy, ERCP, anesthesia, and fluoroscopy.	up to 24 weeks
Health care utilization	Change in frequency of emergency room visits or hospitalization after treatment	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Jeffery J Easler, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Extracorporeal shock wave lithotripsy; Intraductal lithotripsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 1909140534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No