COMPLETED

ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Conditions

Chronic Pancreatitis Pancreatic Duct Stone Extracorporeal shock wave lithotripsy Intraductal lithotripsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2019-11-13

Study Completion:2025-09-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04158297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jeffery J Easler, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Indiana University Health Hospital

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Jeffery J Easler, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-13

Study Completion Date2025-09-05

Study Record Updates

Study Start Date2019-11-13

Study Completion Date2025-09-05

Terms related to this study

Keywords Provided by Researchers

Extracorporeal shock wave lithotripsy
Intraductal lithotripsy

Additional Relevant MeSH Terms

Chronic Pancreatitis
Pancreatic Duct Stone