Choledocholithiasis, Pancreatic Duct Stone
Conditions
Keywords
Laser lithotripsy, choledocholithiasis, pancreaticolithiasis
Brief summary
The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are: Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones. Participants will: Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device. Answer a call 30 days after the procedure to document symptoms and/or any side effects.
Detailed description
This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones. Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or difficult choledocholithiasis or pancreaticolithiasis. Part two of the study will be a non-inferiority study to determine if SOC-LL is non-inferior for stone clearance, among other secondary outcomes, compared to electrohydraulic lithotripsy via single-operator cholangioscopy (SOC-EHL). Patients who meet the inclusion criteria will undergo ERCP procedures and will either undergo SOC-LL or SOC-EHL to treat their large and/or difficult choledocholithiasis or pancreaticolithiasis. Stone clearance and other procedural or safety measures will be assessed after the procedure. The patient will be monitored after the procedure for adverse events and the administration of medications or admission to the hospital will be determined by the proceduralist. Roughly 30 days after the procedure the patient will be called to assess for any adverse effects as well as to determine symptom resolution.
Interventions
DEVICELaser lithotripsy with low-wattage holmium laser
Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.
Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
EHL vs. Laser lithotripsy for choledocholithiasis or pancreaticolithiasis. Single-blind RCT.
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 19-85 years * Signed written informed consent. * Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria: * Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS). * Presence of an impacted stone that cannot be dislodged with a standard balloon or basket. * Stone located proximal to a benign biliary or pancreatic duct stricture. * Documented failure of stone extraction during a prior ERCP attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction).
Exclusion criteria
* Pregnancy: Repeated ERCP would be delayed until after delivery if possible * Clinically significant, uncorrectable coagulopathy (defined as INR \> 1.5 or platelet count \< 50,000/μL). * Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care. * Known or highly suspected malignant biliary or pancreatic stricture associated with the stone. * Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated. * Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia. * Known life expectancy of less than 6 months. * Inability or unwillingness to comply with study procedures or follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete stone clearance | Immediately after the procedure | Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall complete stone clearance rate | Immediately after the final procedure | This describes the rate of complete stone clearance at the end of the final procedure required to completely clear stones, regardless of the number of procedures required to do so. |
| Number of procedures | Immediately after the final procedure | Describes the number of ERCP procedures required to achieve complete stone clearance. |
| Total procedure time | Immediately after the final procedure | Total duration of index ERCP procedure. Will also document total procedural time for all necessary ERCPs to achieve stone clearance. |
| Total lithotripsy time | Immediately after the final procedure | Duration of the activation time for either the laser lithotripsy or the electrohydraulic lithotripsy devices during the study duration. |
| Rate of rescue mechanical lithotripsy | Immediately after the final procedure | Describes the percentage/rate of time that the patient requires rescue mechanical lithotripsy after failure of the primary modality (SOC-LL or SOC-EHL). |
| Length of post-procedure hospital stay | Immediately after the final procedure | Describes the amount of time in days the patient spent in the hospital after any and all required procedures to achieve complete stone clearance. |
Countries
United States
Contacts
CONTACTNeal A Mehta, MD
CONTACTAmanda Lin, DSc, CCRC
PRINCIPAL_INVESTIGATORNeal A Mehta, MD
Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy
Outcome results
None listed