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NCT Number: NCT04158297

ESWL Versus SOPIL for 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone

    Time frame: Up to 24 weeks

    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

  2. Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones

    Time frame: Up to 24 weeks

    Combined lithotripsy and ERCP procedures

  3. Procedural related adverse events

    Time frame: Up to 24 weeks

    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

Secondary outcomes

  1. Change in pain scores

    Time frame: through study completion, an average of 1 year

    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.

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

    Time frame: through study completion, an average of 1 year

    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.

  3. Change in narcotic pain medication usage

    Time frame: through study completion, an average of 1 year

    Change in daily morphine milligram equivalent usage from baseline at 3 months, 6 months, 9 months, and 12 months

  4. Change in exocrine insufficiency

    Time frame: through study completion, an average of 1 year

    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

Other outcomes

  1. Mean cost of care for stone clearance

    Time frame: up to 24 weeks

    Costs will be estimated by procedural fees including the cost of ESWL, lithotripsy, ERCP, anesthesia, and fluoroscopy.

  2. Health care utilization

    Time frame: through study completion, an average of 1 year

    Change in frequency of emergency room visits or hospitalization after treatment

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2019
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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