CholangiocarcinomaEYE/SPYNCT07620080
EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
A study testing EYEMAX® cholangioscopy system and SPYGLASS™ DS system in people with Cholangiocarcinoma and Biliary Stricture, run by David KARSENTI.
Trial summary
Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cholangiocarcinoma, Biliary Stricture
- What is being tested?
- EYEMAX® cholangioscopy system and SPYGLASS™ DS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients aged 18 to 84 years
- 2. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
- 3. Absence of a mass easily accessible to EUS-guided fine needle aspiration
- 4. ASA physical status 1-3
- 5. No participation in another clinical trial
- 6. Written informed consent obtained
- 7. Patient affiliated with a social security system or equivalent
Who cannot join
- 1. Lithiasic biliary obstruction
- 2. Patients younger than 18 years
- 3. ASA 4 or ASA 5 patients
- 4. Pregnant or breastfeeding women
- 5. Coagulation disorders preventing biopsy procedures
- 6. Surgical anatomy preventing papillary access
Show all 13Show fewer
- 7. Patients unable to provide informed consent
- 8. Upper gastrointestinal obstruction
- 9. Intolerance to endoscopy
- 10. Severe cardiopulmonary disease
- 11. Acute pancreatitis or severe cholangitis
- 12. Severe contrast agent allergy
- 13. Patients under legal protection measures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
MORENO MAIRA, PhD contact
About this study
Official title: Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.
The EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.
The primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Being tested
- EYEMAX® cholangioscopy system, SPYGLASS™ DS system
- Keywords
- Cholangioscopy, ERCP, EYEMAX, SpyGlass DS, Biliary biopsy, Cholangiocarcinoma diagnosis
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEMAX® cholangioscopy systemDevice
Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
SPYGLASS™ DS systemDevice
Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
| Study group | Role | What they receive |
|---|---|---|
| Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech). | Experimental | Not described Receives: Device: EYEMAX® cholangioscopy system |
| Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific). | Active comparator | Not described Receives: Device: SPYGLASS™ DS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
The positive diagnostic yield will be assessed for the first four biopsies obtained under cholangioscopy in patients with adenocarcinomatous biliary strictures. This rate will be defined as the ratio between the number of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies and the total number of confirmed adenocarcinomatous biliary strictures.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
This rate will be defined as the proportion of positive pathological diagnoses obtained from all eight cholangioscopy-guided biopsies among all confirmed adenocarcinomatous biliary strictures.
Measured: Through study completion, an average of 1 year
Histological cellularity classification of cholangioscopy-guided biopsy specimens
Biopsy specimen cellularity will be assessed by expert gastrointestinal pathologists and classified into four predefined categories: acellular, low abundance, satisfactory abundance, or rich abundance.
Measured: Through study completion, an average of 1 year
False negative rate of cholangioscopy-guided biopsies
The false negative rate will be defined as the proportion of patients with negative biopsy results despite a final diagnosis of adenocarcinomatous biliary stricture confirmed during follow-up.
Measured: Through study completion, an average of 1 year
Negative predictive value of cholangioscopy-guided biopsies
Negative predictive value will be calculated as the proportion of patients with negative biopsy results who do not have adenocarcinomatous biliary strictures at final diagnosis.
Measured: Through study completion, an average of 1 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
Technical failure will be defined as the inability to access the biliary stricture with the cholangioscope or the inability to obtain biopsy material using the dedicated biopsy forceps.
Measured: Periprocedural
Diagnostic yield of additional biliary sampling techniques
The diagnostic yield of additional biliary sampling techniques, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling, will be evaluated as the proportion of positive pathological diagnoses obtained using each technique.
Measured: Through study completion, an average of 1 year
Number of participants with procedure-related adverse events
Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death.
Measured: Up to Day 30
Mean duration of cholangioscopy-guided biopsy procedures
The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David KARSENTI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David KARSENTI, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620080
- Sponsor's protocol ID
- SFED-160
- Acronym
- EYE/SPY
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
- ClinicalTrials.gov ID
- NCT07620080
- Acronym / sponsor ID
- EYE/SPY / SFED-160
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Keywords
- Cholangioscopy, ERCP, EYEMAX, SpyGlass DS, Biliary biopsy, Cholangiocarcinoma diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- David KARSENTIUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.
The EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.
The primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech). | Experimental | Device: EYEMAX® cholangioscopy system |
| Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific). | Active comparator | Device: SPYGLASS™ DS system |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Adult patients aged 18 to 84 years
- 2. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
- 3. Absence of a mass easily accessible to EUS-guided fine needle aspiration
- 4. ASA physical status 1-3
- 5. No participation in another clinical trial
Key exclusion criteria (13 listed)
- 1. Lithiasic biliary obstruction
- 2. Patients younger than 18 years
- 3. ASA 4 or ASA 5 patients
- 4. Pregnant or breastfeeding women
- 5. Coagulation disorders preventing biopsy procedures
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 |
|---|---|---|
| EYEMAX® cholangioscopy systemCholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice. | Device | Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech). |
| SPYGLASS™ DS systemCholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice. | Device | Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific). |
Primary outcome
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
Time frame: Through study completion, an average of 1 year
The positive diagnostic yield will be assessed for the first four biopsies obtained under cholangioscopy in patients with adenocarcinomatous biliary strictures. This rate will be defined as the ratio between the number of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies and the total number of confirmed adenocarcinomatous biliary strictures.
8 secondary outcomes
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
Time frame: Through study completion, an average of 1 year
Histological cellularity classification of cholangioscopy-guided biopsy specimens
Time frame: Through study completion, an average of 1 year
False negative rate of cholangioscopy-guided biopsies
Time frame: Through study completion, an average of 1 year
Negative predictive value of cholangioscopy-guided biopsies
Time frame: Through study completion, an average of 1 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
Time frame: Periprocedural
Diagnostic yield of additional biliary sampling techniques
Time frame: Through study completion, an average of 1 year
Number of participants with procedure-related adverse events
Time frame: Up to Day 30
Mean duration of cholangioscopy-guided biopsy procedures
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
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.
MORENO MAIRA, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing EYEMAX® cholangioscopy system and SPYGLASS™ DS system in people with Cholangiocarcinoma and Biliary Stricture, run by David KARSENTI.
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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David KARSENTI, MD (+33 1 43 96 78 50, karsenti.paris@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.