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

NCT04115826 | Enrolling By Invitation DMC

• 1 other identifier: 19-0402
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis, Chronic

Keywords

pancreatic duct stone; extracorporeal shock-wave lithotripsy; pancreatoscopy; quality of life; chronic pancreatitis

Outcome Measures

Primary Outcomes (1)

• Stone Clearance Rate

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

  Up to 4 hours (four 1-hour sessions)

Secondary Outcomes (2)

• Change In Quality of Life as Measured Using PANQOLI Score

  At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

• Change in Pain Levels as Measured Using the COMPAT Score

  At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

Study Arms (2)

Extracorporeal Shock-Wave Lithotripsy

PLACEBO COMPARATOR

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.

Procedure: Extracorporeal Shock-Wave Lithotripsy

Per-oral Pancreatoscopy-guided Lithotripsy

ACTIVE COMPARATOR

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.

Procedure: Per-oral Pancreatoscopy-guided Lithotripsy

Interventions

Per-oral Pancreatoscopy-guided Lithotripsy PROCEDURE

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.

Per-oral Pancreatoscopy-guided Lithotripsy

Extracorporeal Shock-Wave Lithotripsy PROCEDURE

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.

Extracorporeal Shock-Wave Lithotripsy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 or surgically altered gastroduodenal anatomy, such as Roux-en-Y 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 abuse and/or illicit drug use, except products containing THC
• Pregnancy
• Patients in active treatment for malignancy other than non-melanoma skin cancer or papillary thyroid cancer

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 36273991 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raj J Shah, MD

  University of Colorado Anschutz Medical Campus, Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator interpreting final stone clearance pancreatograms will be blinded to the intervention received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: January 2, 2020
• Primary Completion: March 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available at the conclusion of the study once the results are published.
• Access Criteria: Formal proposal required

Locations

US (1)