Biliary StrictureNCT01439620
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
A study testing MGH Optical Frequency Domain Imaging (OFDI) in people with Biliary Stricture, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- MGH Optical Frequency Domain Imaging (OFDI)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 20 Jul 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥18 and up to 75 years old
- Patients able to give informed consent
- Patients with bile duct measuring ≥4 mm in diameter
- Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
- Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure
Who cannot join
- Patients with pancreatitis
- Pregnant women
- Patients on oral anticoagulant (warfarin) therapy
- Patients with known history of hemostatic disorder
- Patients found to have a biliary fistula on diagnostic ERCP
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).
Read the detailed description
The study will be conducted in approximately 20 patients with known or suspected common bile duct or common hepatic duct stricture scheduled for endoscopic retrograde cholangiopancreatography (ERCP) with duodenoscope-assisted cholangiopancreatoscopy (DACP) and biopsy.
Following initial fluoroscopic evaluation, the study experimental procedure will begin. The catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla and into the common bile duct. The extra-biliary portion of the catheter will be visible by the duodenoscope at all times. The intrabiliary portion of the catheter will be visible by fluoroscopy, and will be positioned across the biliary stricture. Rotational cross-sectional images of the bile duct will be obtained using the OFDI imaging catheter while pulling back the internal optical components over a pre-determined length. OFDI imaging will be conducted approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by fluoroscopy.
- Conditions
- Biliary Stricture
- Being tested
- MGH Optical Frequency Domain Imaging (OFDI)
- Keywords
- Biliary Stricture, OCT, Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGH Optical Frequency Domain Imaging (OFDI)Device
Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
| Study group | Role | What they receive |
|---|---|---|
| OFDI imaging | Experimental | Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system. Receives: Device: MGH Optical Frequency Domain Imaging (OFDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Imaging the Bile Duct With the OFDI Probe
The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.
Measured: day 1, during diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startFeb 2009
- Primary completion20 Jul 2009
- Study completion20 Jul 2010
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.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD PhD, Principal investigator, Massachusetts General HospitalDavid Forcione, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439620
- Sponsor's protocol ID
- 2008-P-000794
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2011
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
- ClinicalTrials.gov ID
- NCT01439620
- Acronym / sponsor ID
- 2008-P-000794
- Conditions
- Biliary Stricture
- Keywords
- Biliary Stricture, OCT, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- 20 Jul 2009 (actual)
- Study completion
- 20 Jul 2010 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 19 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).
Detailed description
The study will be conducted in approximately 20 patients with known or suspected common bile duct or common hepatic duct stricture scheduled for endoscopic retrograde cholangiopancreatography (ERCP) with duodenoscope-assisted cholangiopancreatoscopy (DACP) and biopsy.
Following initial fluoroscopic evaluation, the study experimental procedure will begin. The catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla and into the common bile duct. The extra-biliary portion of the catheter will be visible by the duodenoscope at all times. The intrabiliary portion of the catheter will be visible by fluoroscopy, and will be positioned across the biliary stricture. Rotational cross-sectional images of the bile duct will be obtained using the OFDI imaging catheter while pulling back the internal optical components over a pre-determined length. OFDI imaging will be conducted approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by fluoroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFDI imaging | Experimental | Device: MGH Optical Frequency Domain Imaging (OFDI)Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age ≥18 and up to 75 years old
- Patients able to give informed consent
- Patients with bile duct measuring ≥4 mm in diameter
- Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
- Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure
Key exclusion criteria (5 listed)
- Patients with pancreatitis
- Pregnant women
- Patients on oral anticoagulant (warfarin) therapy
- Patients with known history of hemostatic disorder
- Patients found to have a biliary fistula on diagnostic ERCP
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 |
|---|---|---|
| MGH Optical Frequency Domain Imaging (OFDI)Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System | Device | OFDI imaging |
Primary outcome
Feasibility of Imaging the Bile Duct With the OFDI Probe
Time frame: day 1, during diagnostic procedure
The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Guillermo Tearney, MD PhD principal investigator
Massachusetts General Hospital
David Forcione, MD principal investigator
Massachusetts General 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 MGH Optical Frequency Domain Imaging (OFDI) in people with Biliary Stricture, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 5 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 10 Apr 2019. 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 United States. 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 19 Sep 2018). 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?
Feasibility of Imaging the Bile Duct With the OFDI Probe (time frame: day 1, during diagnostic procedure). 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 10 Apr 2019.