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NCT04158297 · ClinicalTrials.gov registry record · NA
ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
A NA study of Chronic Pancreatitis and Pancreatic Duct Stone, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04158297 is a NA study of Chronic Pancreatitis and Pancreatic Duct Stone that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 688-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04158297, a NA study of Chronic Pancreatitis and Pancreatic Duct Stone, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE ESWL vs SOPIL
Study Locations (1)
Indiana
- Indiana University Health Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2025-09-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04158297
The ClinicalTrials.gov registry entry for NCT04158297 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 688-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (96% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Pancreatitis appearing as the primary indexed condition, and to 1 intervention - of which ESWL vs SOPIL is the first listed.
NCT04158297 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT04158297 about?
NCT04158297 is a clinical study titled "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 wit...
What is the current status of trial NCT04158297?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-11-13. Estimated completion is 2025-09-05.
What conditions does trial NCT04158297 study?
This clinical trial studies the following conditions: Chronic Pancreatitis, Pancreatic Duct Stone.
What interventions are being tested in trial NCT04158297?
The interventions under investigation include: ESWL vs SOPIL (PROCEDURE).
Who is sponsoring clinical trial NCT04158297?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158297 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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