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

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Brief Title

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

Official Title

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

Brief 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
    



Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Change in pain scores

Condition

Chronic Pancreatitis

Intervention

ESWL vs SOPIL

Study Arms / Comparison Groups

 ESWL
Description:  Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

60

Start Date

November 13, 2019

Completion Date

November 2023

Primary Completion Date

November 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Benjamin L Bick, MD, 317-274-8407, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04158297

Organization ID

1909140534


Responsible Party

Principal Investigator

Study Sponsor

Indiana University


Study Sponsor

Benjamin L Bick, MD, Principal Investigator, Indiana University


Verification Date

February 2021