ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis

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Brief Title

ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis

Official Title

Per-oral Pancreatoscopy-guided Lithotripsy vs. Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis

Brief Summary

      This is a multi-center randomized controlled trial comparing extracorporeal shock-wave
      lithotripsy (ESWL) with per-oral pancreatoscopy-guided lithotripsy (PPL) in the treatment of
      patients with chronic pancreatitis and refractory main pancreatic duct stones. This study
      will be comparing the two treatment options for patients who have stones that fail initial
      endoscopic therapy via endoscopic retrograde pancreatography (ERCP). The study will look at
      the stone clearance rates and patient-centered outcomes including quality of life and pain.
    

Detailed Description

      Patients with chronic pancreatitis frequently develop obstructing pancreatic duct stones
      which can lead to severe pain. Current standard methods to remove these stones include ERCP
      and extracorporeal shock-wave lithotripsy (ESWL) which are limited in removing larger and
      multiple impacted stones. Availability in the USA of ESWL for this indication also may be
      limited even at major referral centers. The introduction of single-operator per-oral
      pancreatoscopy (SpyGlassTM) has enabled direct intraductal visualization to target stones.
      Retrospective studies demonstrate a high success rate but literature is quite limited,
      uncontrolled, and highly selective. Further, many experts and recent European Society
      Guidelines suggest that ESWL is the only primary therapy for larger stones (5mm or larger)
      and that intraductal endoscopy and lithotripsy should only be used for 'salvage' therapy in
      select patients.

      A critical need exists to compare the efficacy of per oral pancreatoscopy-guided lithotripsy
      (PPL) with ESWL to determine which therapy is most efficacious in removing refractory PD
      stones. The investigators believe ERCP with POP has distinct advantages of localizing
      'shocks' to the stones, helping to identify and treat underlying strictures in the duct, and
      lithotripsy of multiple stones can be performed at a single session with a recent
      multi-center international retrospective study showing all stones removed in a single session
      in over 70% of cases. Therefore, this project seeks to change the perceived standard of care
      as it relates to symptomatic pancreatic duct stones in this population, shifting the pendulum
      towards endoscopic and specifically pancreatoscopy-guided therapy.
    


Study Type

Interventional


Primary Outcome

Stone Clearance Rate

Secondary Outcome

 Change In Quality of Life as Measured Using PANQOLI Score

Condition

Pancreatitis, Chronic

Intervention

Per-oral Pancreatoscopy-guided Lithotripsy

Study Arms / Comparison Groups

 Extracorporeal Shock-Wave Lithotripsy
Description:  Stone localization will first be performed by obtaining high-quality plain films of the pancreatic area in left and right oblique positions using a two-dimensional radiologic targeting system.Depending on the stone localization, ESWL will then be performed with the patient in either slight left or right lateral decubitus with shock waves entering the body from the ventral side. The shockwaves will be focused first on the most distally located stone within the main duct and then on other calculi moving from the head towards the body. If a stent has been inserted during preceding ERP then this may also serve as a guide to target main pancreatic duct stones by ESWL. A total of one hour of ESWL at a rate of 60-120 shocks/minute will be delivered in one treatment session.

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

Procedure

Estimated Enrollment

150

Start Date

January 2, 2020

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects with abdominal pain secondary to chronic calcific pancreatitis and main
             pancreatic duct stones found on cross-sectional imaging, EUS, or ERP.

          -  Subjects aged 18-80.

          -  Subjects must have failed at least one prior attempt of standard ERP to remove the PD
             stones.

          -  Main PD stones in the head or body that are greater than 50% of the immediate
             downstream diameter of the pancreatic duct.

          -  Stones ≥5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS.
             If multiple locations of stones are noted within the main PD, pancreatic tail stones
             cannot comprise more than one-third of the stone burden within the main PD.

        Exclusion Criteria:

          -  Subjects who have previously received PPL or ESWL.

          -  Patients with PD stones isolated in the tail or side branches of the main duct.

          -  Inability to place a transpapillary pancreatic duct stent at index ERP.

          -  Patients with prior pancreatic surgery

          -  Pancreas divisum or acquired pancreas divisum requiring minor papilla cannulation

          -  Pregnancy

          -  Significant cardiopulmonary co-morbidities precluding general anesthesia

          -  Patients with implanted cardiac pacemakers or defibrillators

          -  Patients with coagulation disorders that cannot be corrected to an INR below 2.0
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Raj J Shah, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04115826

Organization ID

19-0402


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver


Study Sponsor

Raj J Shah, MD, Principal Investigator, University of Colorado - Anschutz Medical Campus


Verification Date

April 2021