Trial Outcomes & Findings for Non-Complex Biliary Stones DSC vs ERC (NCT NCT03421340)
NCT ID: NCT03421340
Last Updated: 2025-01-17
Results Overview
Prospectively compare DSC vs. ERC
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
30 Days
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
124
|
|
Overall Study
COMPLETED
|
115
|
117
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ERC Arm
n=126 Participants
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.
|
DSC Arm
n=124 Participants
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.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 16.7 • n=126 Participants
|
50.3 years
STANDARD_DEVIATION 18 • n=124 Participants
|
52 years
STANDARD_DEVIATION 17.4 • n=250 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=126 Participants
|
79 Participants
n=124 Participants
|
150 Participants
n=250 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=126 Participants
|
45 Participants
n=124 Participants
|
100 Participants
n=250 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
40 participants
n=126 Participants
|
39 participants
n=124 Participants
|
79 participants
n=250 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=126 Participants
|
1 participants
n=124 Participants
|
1 participants
n=250 Participants
|
|
Region of Enrollment
Thailand
|
27 participants
n=126 Participants
|
26 participants
n=124 Participants
|
53 participants
n=250 Participants
|
|
Region of Enrollment
India
|
59 participants
n=126 Participants
|
58 participants
n=124 Participants
|
117 participants
n=250 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: ITT
Prospectively compare DSC vs. ERC
Outcome measures
| Measure |
ERC Arm
n=126 Participants
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.
|
DSC Arm
n=124 Participants
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.
|
|---|---|---|
|
Number of Participants With Complete Stone Clearance
|
112 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: ITT
To evaluate all SAEs including death, severity, onset, time to resolution.
Outcome measures
| Measure |
ERC Arm
n=126 Participants
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.
|
DSC Arm
n=124 Participants
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.
|
|---|---|---|
|
Rate of Serious Adverse Events
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 hoursTotal Fluoroscopy time
Outcome measures
| Measure |
ERC Arm
n=126 Participants
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.
|
DSC Arm
n=124 Participants
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.
|
|---|---|---|
|
Radiation Exposure
|
133 seconds
Interval 0.0 to 720.0
|
0 seconds
Interval 0.0 to 454.0
|
SECONDARY outcome
Timeframe: 3 hoursDefined as time from duodenoscope in to completion of stone clearance.
Outcome measures
| Measure |
ERC Arm
n=126 Participants
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.
|
DSC Arm
n=124 Participants
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.
|
|---|---|---|
|
Duration of Procedure
|
11.9 minutes
Interval 3.8 to 137.9
|
22.1 minutes
Interval 6.0 to 67.0
|
Adverse Events
ERC Arm
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
DSC Arm
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ERC Arm
n=126 participants at risk
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.
|
DSC Arm
n=124 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
3/126 • Number of events 3 • 30 days
|
4.0%
5/124 • Number of events 5 • 30 days
|
|
Injury, poisoning and procedural complications
Duodenal injury
|
0.00%
0/126 • 30 days
|
0.81%
1/124 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.79%
1/126 • Number of events 1 • 30 days
|
0.81%
1/124 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/126 • Number of events 1 • 30 days
|
0.00%
0/124 • 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.79%
1/126 • Number of events 1 • 30 days
|
0.00%
0/124 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place