Biliary StonesNCT03421340
Non-Complex Biliary Stones DSC vs ERC
A study testing DSC and ERC in people with Biliary Stones, run by Boston Scientific Corporation at 8 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stones
- What is being tested?
- DSC and ERC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 21 Sep 2018to 8 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain)
- Abnormal LFTs
- 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
- 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
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- If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable.
- 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.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Who cannot join
- Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated
- Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures
- Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible
- Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla
- Patients with prior biliary sphincterotomy
- Patients with Primary Sclerosing Cholangitis (PSC)
Show all 9Show fewer
- 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
- Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures
- Coagulopathy or ongoing need for anti-coagulation
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
University of Colorado Hospital, Denver
Aurora, Colorado, 80045
Ertan Digestive Disease Center - University of Texas Health Science Center
Houston, Texas, 77030
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Stanford University Medical Center
Stanford, California, 94305
India2 sites
Asian Institute of Gastroenterology
Hyderabad, Somajiguda, 500082
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, 700054
Thailand1 site
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
About this study
Official title: Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
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).
Read the 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).
- Conditions
- Biliary Stones
- Being tested
- DSC, ERC
- Keywords
- ERCP, DSC, Spy Glass, Biliary Stones, Choledocholithiasis, Non-Complex, Stones
- Medical subject headings
- Cholecystolithiasis, Choledocholithiasis, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSCDevice
Also called Direct Solitary Cholangioscopy
Stone removal without fluoroscopy using the SpyGlass device.
ERCDevice
Also called Endoscopic Retrograde Cholangiography
Standard of care stone removal with fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| ERC Arm | Other | 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. Receives: Device: ERC |
| DSC Arm | Other | 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). Receives: Device: DSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Stone Clearance
Prospectively compare DSC vs. ERC
Measured: 30 Days
Secondary outcomes (3)
Rate of Serious Adverse Events
To evaluate all SAEs including death, severity, onset, time to resolution.
Measured: 30 Days
Radiation Exposure
Total Fluoroscopy time
Measured: 3 hours
Duration of Procedure
Defined as time from duodenoscope in to completion of stone clearance.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start21 Sep 2018
- Primary completion18 Sep 2023
- Study completion8 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biliary StonesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Subhash Banerjee, MD, Principal investigator, Stanford UniversityNirav Thosani, MD, Principal investigator, Univeristy of Texas Health SciencesRaj J Shah, MD, Principal investigator, University of Colorado, DenverMohan Ramchandani, MD, Principal investigator, Asian Institure of GastroenterologyGuido Costamagna, MD, Principal investigator, Fundazione Policlinico UniversitarioRungsun Rerknimitr, MD, Principal investigator, King Chulalongkorn Memorial HospitalJanak N Shah, MD, Principal investigator, Ochsner Health SystemMahesh Goenka, MD, Principal investigator, Apollo Gleneagles Hospitals, Kolkata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421340
- Sponsor's protocol ID
- E7131
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2018
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Banerjee S, Goenka MK, Ramchandani M, Shah RJ, Lakhtakia S, Ridtitid W, Shah JN, Thosani N, Wagh MS, Costamagna G, Peetermans JA, Rousseau MJ, Rerknimitr R. Fluoroscopy-free direct solitary cholangioscopy versus endoscopic retrograde cholangiography for clearance of noncomplex biliary stones: a noninferiority randomized controlled trial. Gastrointest Endosc. 2026 Aug;104(2):255-263. doi: 10.1016/j.gie.2025.12.283. Epub 2026 Jan 16.
PubMed 41548725Ridtitid W, Rerknimitr R, Ramchandani M, Lakhtakia S, Shah RJ, Shah JN, Thosani N, Goenka MK, Costamagna G, Wagh MS, Perri V, Peetermans J, Goswamy PG, Liu Z, Yin S, Banerjee S. Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience. DEN Open. 2023 Jun 1;4(1):e241. doi: 10.1002/deo2.241. eCollection 2024 Apr.
PubMed 37273518
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
- ClinicalTrials.gov ID
- NCT03421340
- Acronym / sponsor ID
- E7131
- Conditions
- Biliary Stones
- Keywords
- ERCP, DSC, Spy Glass, Biliary Stones, Choledocholithiasis, Non-Complex, Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 8 Oct 2023 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERC Arm | Other | Device: ERCAfter 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. |
| DSC Arm | Other | Device: DSCAfter 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain)
- Abnormal LFTs
- 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*
- 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
Key exclusion criteria (9 listed)
- Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated
- Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures
- Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible
- Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla
- Patients with prior biliary sphincterotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSCAlso: Direct Solitary CholangioscopyStone removal without fluoroscopy using the SpyGlass device. | Device | DSC Arm |
| ERCAlso: Endoscopic Retrograde CholangiographyStandard of care stone removal with fluoroscopy. | Device | ERC Arm |
Primary outcome
Number of Participants With Complete Stone Clearance
Time frame: 30 Days
Prospectively compare DSC vs. ERC
3 secondary outcomes
Rate of Serious Adverse Events
Time frame: 30 Days
Radiation Exposure
Time frame: 3 hours
Duration of Procedure
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41548725Banerjee S, Goenka MK, Ramchandani M, Shah RJ, Lakhtakia S, Ridtitid W, Shah JN, Thosani N, Wagh MS, Costamagna G, Peetermans JA, Rousseau MJ, Rerknimitr R. Fluoroscopy-free direct solitary cholangioscopy versus endoscopic retrograde cholangiography for clearance of noncomplex biliary stones: a noninferiority randomized controlled trial. Gastrointest Endosc. 2026 Aug;104(2):255-263. doi: 10.1016/j.gie.2025.12.283. Epub 2026 Jan 16.
- Derived from this study: PubMed 37273518Ridtitid W, Rerknimitr R, Ramchandani M, Lakhtakia S, Shah RJ, Shah JN, Thosani N, Goenka MK, Costamagna G, Wagh MS, Perri V, Peetermans J, Goswamy PG, Liu Z, Yin S, Banerjee S. Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience. DEN Open. 2023 Jun 1;4(1):e241. doi: 10.1002/deo2.241. eCollection 2024 Apr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhash Banerjee, MD principal investigator
Stanford University
Nirav Thosani, MD principal investigator
Univeristy of Texas Health Sciences
Raj J Shah, MD principal investigator
University of Colorado, Denver
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSC and ERC in people with Biliary Stones, run by Boston Scientific Corporation at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, India, Italy, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Stone Clearance (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.