ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

NCT04158297 | Completed DMC

• 1 other identifier: 1909140534
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pancreatitis; Pancreatic Duct Stone

Keywords

Extracorporeal shock wave lithotripsy; Intraductal lithotripsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in pain scores

  through study completion, an average of 1 year

• Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI

  through study completion, an average of 1 year

• Change in narcotic pain medication usage

  through study completion, an average of 1 year

• Change in exocrine insufficiency

  through study completion, an average of 1 year

Other Outcomes (2)

• Mean cost of care for stone clearance

  up to 24 weeks

• Health care utilization

  through study completion, an average of 1 year

Study Arms (2)

ESWL

ACTIVE COMPARATOR

Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones

Procedure: ESWL vs SOPIL

SOPIL

ACTIVE COMPARATOR

Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Procedure: ESWL vs SOPIL

Interventions

ESWL vs SOPIL PROCEDURE

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.

ESWL; SOPIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffery J Easler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 13, 2019
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)