Chronic PancreatitisNCT04158297
ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
A study testing ESWL vs SOPIL in people with Chronic Pancreatitis and Pancreatic Duct Stone, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Duct Stone
- What is being tested?
- ESWL vs SOPIL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Hospital
Indianapolis, Indiana, 46202
About this study
Official title: 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
- Conditions
- Chronic Pancreatitis, Pancreatic Duct Stone
- Being tested
- ESWL vs SOPIL
- Keywords
- Extracorporeal shock wave lithotripsy, Intraductal lithotripsy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL vs SOPILProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ESWL | Active comparator | Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones Receives: Procedure: ESWL vs SOPIL |
| SOPIL | Active comparator | Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones Receives: Procedure: ESWL vs SOPIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 24 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start13 Nov 2019
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Easler, Indiana University
- Investigators
- Jeffery J Easler, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158297
- Sponsor's protocol ID
- 1909140534
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
- ClinicalTrials.gov ID
- NCT04158297
- Acronym / sponsor ID
- 1909140534
- Conditions
- Chronic Pancreatitis, Pancreatic Duct Stone
- Keywords
- Extracorporeal shock wave lithotripsy, Intraductal lithotripsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL | Active comparator | Procedure: ESWL vs SOPILExtracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones |
| SOPIL | Active comparator | Procedure: ESWL vs SOPILSingle Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWL vs SOPILTo 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. | Procedure or surgery | ESWL, SOPIL |
Primary outcome
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
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
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
4 secondary outcomes
Change in pain scores
Time frame: through study completion, an average of 1 year
Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI
Time frame: through study completion, an average of 1 year
Change in narcotic pain medication usage
Time frame: through study completion, an average of 1 year
Change in exocrine insufficiency
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery J Easler, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWL vs SOPIL in people with Chronic Pancreatitis and Pancreatic Duct Stone, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.