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

Primary Purpose

Pancreatitis, Chronic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Per-oral Pancreatoscopy-guided Lithotripsy
Extracorporeal Shock-Wave Lithotripsy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Chronic focused on measuring pancreatic duct stone, extracorporeal shock-wave lithotripsy, pancreatoscopy, quality of life, chronic pancreatitis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Extracorporeal Shock-Wave Lithotripsy

Per-oral Pancreatoscopy-guided Lithotripsy

Arm 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.

Standard ERP will be performed to cannulate the PD, perform pancreatic sphincterotomy, and stricture dilation as necessary. A pancreatoscope (Spyglass Digital System, Boston Scientific, Marlborough, MA) will then be inserted through the duodenoscope into the PD. For PPL, electrical pulses will be delivered through an aqueous medium by EHL or LL with the probe tip in contact with or 1-2mm away from the stone. Settings for EHL (1.9F fiber; Autolith, Northgate Technologies, Elgin, IL) are 10-20 pulses/second with a power of 50-100; and for LL (200, 272, or 365 micrometer fiber, Versa Pulse Power Suite 20-W Holmium laser, New Star, Roseville, CA) ranging from 0.8 - 2.5 Joules with a frequency of 8-15Hz and power of 9-30 W. A maximum of 1 hour of intraductal lithotripsy will be allowed to reduce performance bias.

Outcomes

Primary Outcome Measures

Stone Clearance Rate
The rate of complete clearance of the main pancreatic duct of all stones.

Secondary Outcome Measures

Change In Quality of Life as Measured Using PANQOLI Score
Change in quality of life as measured using the PANQOLI (PANcreatitis Quality of Life Instrument), a chronic pancreatitis-specific quality of life instrument. This instrument has a score range from 0 to 100, which higher scores denoting better quality of life. The questionnaire has 18 items and questions 1, 2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, and 18 are reverse scored while items 7, 8, 9, 10, and 11 are scored at face value. The final score is the sum of the scores from all 18 questions.
Change in Pain Levels as Measured Using the COMPAT Score
Change in pain levels as measured using the comprehensive pain assessment tool, (COMPAT), a chronic pancreatitis-specific pain questionnaire. The questionnaire consists of 23 questions. A score is assessed for question # 14, which consists of 28 questions with scores ranging from 0 to 10, with 10 representing worse pain. A maximum score of 280 is possible for this component of the COMPAT.

Full Information

First Posted
October 2, 2019
Last Updated
April 14, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04115826
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic
Keywords
pancreatic duct stone, extracorporeal shock-wave lithotripsy, pancreatoscopy, quality of life, chronic pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator interpreting final stone clearance pancreatograms will be blinded to the intervention received.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Shock-Wave Lithotripsy
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Per-oral Pancreatoscopy-guided Lithotripsy
Arm Type
Active Comparator
Arm Description
Standard ERP will be performed to cannulate the PD, perform pancreatic sphincterotomy, and stricture dilation as necessary. A pancreatoscope (Spyglass Digital System, Boston Scientific, Marlborough, MA) will then be inserted through the duodenoscope into the PD. For PPL, electrical pulses will be delivered through an aqueous medium by EHL or LL with the probe tip in contact with or 1-2mm away from the stone. Settings for EHL (1.9F fiber; Autolith, Northgate Technologies, Elgin, IL) are 10-20 pulses/second with a power of 50-100; and for LL (200, 272, or 365 micrometer fiber, Versa Pulse Power Suite 20-W Holmium laser, New Star, Roseville, CA) ranging from 0.8 - 2.5 Joules with a frequency of 8-15Hz and power of 9-30 W. A maximum of 1 hour of intraductal lithotripsy will be allowed to reduce performance bias.
Intervention Type
Procedure
Intervention Name(s)
Per-oral Pancreatoscopy-guided Lithotripsy
Intervention Description
Per-oral Pancreatoscopy-guided lithotripsy will be administered for a maximum of 4 sessions (1 hour max per session). Either electrohydraulic lithotripsy or laser lithotripsy will be allowed during the session at the discretion of the endoscopist.
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock-Wave Lithotripsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone Clearance Rate
Description
The rate of complete clearance of the main pancreatic duct of all stones.
Time Frame
Up to 4 hours (four 1-hour sessions)
Secondary Outcome Measure Information:
Title
Change In Quality of Life as Measured Using PANQOLI Score
Description
Change in quality of life as measured using the PANQOLI (PANcreatitis Quality of Life Instrument), a chronic pancreatitis-specific quality of life instrument. This instrument has a score range from 0 to 100, which higher scores denoting better quality of life. The questionnaire has 18 items and questions 1, 2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, and 18 are reverse scored while items 7, 8, 9, 10, and 11 are scored at face value. The final score is the sum of the scores from all 18 questions.
Time Frame
At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up
Title
Change in Pain Levels as Measured Using the COMPAT Score
Description
Change in pain levels as measured using the comprehensive pain assessment tool, (COMPAT), a chronic pancreatitis-specific pain questionnaire. The questionnaire consists of 23 questions. A score is assessed for question # 14, which consists of 28 questions with scores ranging from 0 to 10, with 10 representing worse pain. A maximum score of 280 is possible for this component of the COMPAT.
Time Frame
At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged 18-89 Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP with upstream PD dilation Main PD stones in the head or body that are greater than 50% in size 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 Exclusion Criteria: Subjects who have previously received PPL or ESWL for PD stones within 12 months of enrollment Patients with PD stones isolated in the tail or side branches of the main duct Pancreatic tail stones comprising more than one-third of the stone burden within the main PD, if multiple locations of stones are noted within the main PD Nontraversable ansa loop with upstream stones Inability to place a transpapillary pancreatic duct stent during ERP Patients with prior pancreatic surgery Acquired pancreas divisum Significant cardiopulmonary co-morbidities precluding general anesthesia Patients with coagulation disorders that cannot be corrected to an INR below 2.0 Patients with ongoing alcohol and/or illicit drug use Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj J Shah, MD
Organizational Affiliation
University of Colorado Anschutz Medical Campus, Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available to researchers
IPD Sharing Time Frame
The data will become available at the conclusion of the study once the results are published.
IPD Sharing Access Criteria
Formal proposal required
Citations:
PubMed Identifier
36273991
Citation
Han S, Miley A, Akshintala V, Freeman ML, Kahaleh M, Othman M, Patel S, Papachristou GI, Raijman I, Sankey N, Sayana H, Singh V, Tarnasky P, Trikudanathan G, Shah RJ. Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial. Pancreatology. 2022 Dec;22(8):1120-1125. doi: 10.1016/j.pan.2022.09.245. Epub 2022 Oct 15.
Results Reference
derived

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

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