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Shock wave showdown: which Stone-Busting method wins?

NCT ID NCT04158297

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study compares two procedures for breaking up large stones in the pancreatic duct of people with chronic pancreatitis. One method uses shock waves from outside the body, while the other uses a tiny scope and laser during an ERCP. The goal is to see which technique clears stones better, with fewer side effects, and improves pain over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
procedure
What this could lead to
If successful, this could identify the better method for removing large pancreatic stones, potentially easing pain and reducing the need for repeat procedures.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to everyone. Both procedures carry risks like bleeding, infection, or pancreatitis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Nov 2019

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pancreatitis Pancreatic duct stone

Contacts and locations

Locations

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202, United States

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