Benign Biliary StricturesNCT01238900
Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures
An observational study of Benign Biliary Strictures, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Biliary Strictures
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2015
- Phase
- Observational
- 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
Study population: Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.
Who may be able to join
- Subject is 18 years or older
- Subject has benign biliary stricture
- Subject must be able to give informed consent
Who cannot join
- Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- The subject is unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands at UF endoscopy center
Gainesville, Florida, 32608
About this study
Official title: Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.
Read the detailed description
In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.
- Conditions
- Benign Biliary Strictures
- Being tested
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde Cholangiopancreatography (ERCP)Procedure or surgery
Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct
| Study group | Role | What they receive |
|---|---|---|
| benign biliary strictures | All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Term Success Rate in the Resolution of Biliary Strictures
Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.
Measured: 6 months
Long-term Success Rate in Resolution of Biliary Strictures
Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.
Measured: at least 12 months after stent removal
Secondary outcomes (3)
Number of Endoscopic Treatments Per Patient
The average number of ERCPs performed per patient required for resolution of benign strictures.
Measured: At time of procedure
Ease of Stent Removal
The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).
Measured: at time of procedure
Frequency and Severity of Adverse Events (Including Stent Migration)
Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2015
- Study completionMay 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Benign Biliary StricturesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238900
- Sponsor's protocol ID
- Benign Biliary Strictures
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2010
- Last updated
- 2 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.
PubMed 23956613
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
- ClinicalTrials.gov ID
- NCT01238900
- Acronym / sponsor ID
- Benign Biliary Strictures
- Conditions
- Benign Biliary Strictures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 2 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.
Detailed description
In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| benign biliary strictures | – | Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.
Key inclusion criteria (3 listed)
- Subject is 18 years or older
- Subject has benign biliary stricture
- Subject must be able to give informed consent
Key exclusion criteria (2 listed)
- Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- The subject is unable to give informed consent
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 |
|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography (ERCP)Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct | Procedure or surgery | benign biliary strictures |
Primary outcome
Short Term Success Rate in the Resolution of Biliary Strictures
Time frame: 6 months
Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.
Long-term Success Rate in Resolution of Biliary Strictures
Time frame: at least 12 months after stent removal
Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.
3 secondary outcomes
Number of Endoscopic Treatments Per Patient
Time frame: At time of procedure
Ease of Stent Removal
Time frame: at time of procedure
Frequency and Severity of Adverse Events (Including Stent Migration)
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23956613Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.
Related trials for Benign Biliary Strictures
Recruiting
Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
Chronic Pancreatitis, Benign Biliary Stricture
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.
Peter Draganov, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Biliary Strictures, run by University of Florida 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 3 inclusion and 2 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 2 Oct 2015. 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 2 Oct 2015). 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?
Short Term Success Rate in the Resolution of Biliary Strictures (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT01238900, which also lists 1 linked publication.
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 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.