Bile Duct StrictureNCT05320497
Transparent Cap-assisted SpyGlass for Biliary Stricture
A study testing Transparent cap in people with Bile Duct Stricture and Endoscopic Retrograde Cholangiopancreatography, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease
- What is being tested?
- Transparent cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The indications for ERCP.
- Written informed consent
Who cannot join
- Underlying bleeding disorder
- The platelet count less than 50×10^9/L
- Serious cardio-pulmonary, hepatic or renal disease
- Intolerance to ERCP
- Other high-risk conditions or disease (such as massive ascites, etc.)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of Chinese PLA General Hosptial
Beijing, Beijing Municipality, 100039
Yan Liu, MD, +8613911798288, 13911798288@163.com
About this study
Official title: Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture
The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.
Read the detailed description
Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.
- Conditions
- Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease, Biliary Tract Neoplasms
- Being tested
- Transparent cap
- Keywords
- Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy
- Medical subject headings
- Gallbladder Diseases, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparent capDevice
Add a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations
| Study group | Role | What they receive |
|---|---|---|
| Transparent cap-assisted SpyGlass | Experimental | Add a transparent cap to the end of the SpyGlass choledochoscopy Receives: Device: Transparent cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clearness of visual field
The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Measured: Immediately
Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations
Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass
Measured: Immediately
Secondary outcomes (1)
Biopsy accuracy
Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start14 Apr 2022
- Primary completion10 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StrictureStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, MD, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320497
- Sponsor's protocol ID
- Transparent Cap
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture
- ClinicalTrials.gov ID
- NCT05320497
- Acronym / sponsor ID
- Transparent Cap
- Conditions
- Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease, Biliary Tract Neoplasms
- Keywords
- Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 11 Apr 2022 (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.
The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.
Detailed description
Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
| Arm | Type | Receives |
|---|---|---|
| Transparent cap-assisted SpyGlass | Experimental | Device: Transparent capAdd a transparent cap to the end of the SpyGlass choledochoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The indications for ERCP.
- Written informed consent
Key exclusion criteria (6 listed)
- Underlying bleeding disorder
- The platelet count less than 50×10^9/L
- Serious cardio-pulmonary, hepatic or renal disease
- Intolerance to ERCP
- Other high-risk conditions or disease (such as massive ascites, etc.)
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 |
|---|---|---|
| Transparent capAdd a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations | Device | Transparent cap-assisted SpyGlass |
Primary outcome
The clearness of visual field
Time frame: Immediately
The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations
Time frame: Immediately
Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass
1 secondary outcome
Biopsy accuracy
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Yan Liu, MD principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transparent cap in people with Bile Duct Stricture and Endoscopic Retrograde Cholangiopancreatography, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Liu, MD (13911798288, 13911798288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clearness of visual field (time frame: Immediately). The study lists 2 primary outcomes in all. 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 15 Apr 2022.