Biliary Stones
Conditions
Keywords
ERCP, DSC, Spy Glass, Biliary Stones, Choledocholithiasis, Non-Complex, Stones
Brief summary
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).
Detailed description
The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).
Interventions
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain) 3. Abnormal LFTs 4. Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. If stones not seen on imaging (US, CT) the bile duct diameter should be ≤12 mm\* \* Given the poor sensitivity (approximately 20%) for biliary stones of CT and US, the diameter of the dilated CBD is used as a surrogate for largest stone diameter 5. Availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging 1. If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable. 2. If the probability of stones is either intermediate or low per investigator assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm presence of stones. 6. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion criteria
1. Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated 2. Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures 3. Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible 4. Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla 5. Patients with prior biliary sphincterotomy 6. Patients with Primary Sclerosing Cholangitis (PSC) 7. Acute pancreatitis, defined as abdominal pain and serum concentration of pancreatic enzymes \[lipase (required), amylase (optional)\] three or more times the upper limit of normal 8. Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures 9. Coagulopathy or ongoing need for anti-coagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Stone Clearance | 30 Days | Prospectively compare DSC vs. ERC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events | 30 Days | To evaluate all SAEs including death, severity, onset, time to resolution. |
| Radiation Exposure | 3 hours | Total Fluoroscopy time |
| Duration of Procedure | 3 hours | Defined as time from duodenoscope in to completion of stone clearance. |
Countries
India, Italy, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ERC Arm After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Endoscopic Retrograde Cholangioscopy (ERC) treatment.
ERC: Standard of care stone removal with fluoroscopy. | 126 |
| DSC Arm After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC).
DSC: Stone removal without fluoroscopy using the SpyGlass device. | 124 |
| Total | 250 |
Baseline characteristics
| Characteristic | DSC Arm | Total | ERC Arm |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 18 | 52 years STANDARD_DEVIATION 17.4 | 53.6 years STANDARD_DEVIATION 16.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment India | 58 participants | 117 participants | 59 participants |
| Region of Enrollment Italy | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Thailand | 26 participants | 53 participants | 27 participants |
| Region of Enrollment United States | 39 participants | 79 participants | 40 participants |
| Sex: Female, Male Female | 79 Participants | 150 Participants | 71 Participants |
| Sex: Female, Male Male | 45 Participants | 100 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 126 | 1 / 124 |
| other Total, other adverse events | 0 / 126 | 0 / 124 |
| serious Total, serious adverse events | 5 / 126 | 7 / 124 |
Outcome results
Primary
Number of Participants With Complete Stone Clearance
Prospectively compare DSC vs. ERC
Time frame: 30 Days
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ERC Arm | Number of Participants With Complete Stone Clearance | 112 Participants |
| DSC Arm | Number of Participants With Complete Stone Clearance | 108 Participants |
p-value: 0.029exact
Secondary
Duration of Procedure
Defined as time from duodenoscope in to completion of stone clearance.
Time frame: 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERC Arm | Duration of Procedure | 11.9 minutes |
| DSC Arm | Duration of Procedure | 22.1 minutes |
95% CI: [-11.6, -7.5]
Secondary
Radiation Exposure
Total Fluoroscopy time
Time frame: 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERC Arm | Radiation Exposure | 133 seconds |
| DSC Arm | Radiation Exposure | 0 seconds |
95% CI: [120, 143]
Secondary
Rate of Serious Adverse Events
To evaluate all SAEs including death, severity, onset, time to resolution.
Time frame: 30 Days
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ERC Arm | Rate of Serious Adverse Events | 5 Participants |
| DSC Arm | Rate of Serious Adverse Events | 7 Participants |
95% CI: [-8, 4.1]