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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| benign biliary strictures | All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography (ERCP) | Procedure | Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | at least 12 months after stent removal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Endoscopic Treatments Per Patient | The average number of ERCPs performed per patient required for resolution of benign strictures. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Draganov, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at UF endoscopy center | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23956613 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Benign Biliary Strictures | Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Months Post Stent Placement |
| |||||||||||||
| <12 Months Post Stent Removal |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Benign Biliary Strictures | Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others. | Posted | Number | participants | 6 months |
|
7.5 months
Stent migration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benign Biliary Strictures | Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stent migration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | 9 subjects (39.1% of participants) had stent migration and required additional endoscopy to remove the stent |
Fifty-six percent of our patients had prior therapy for their benign biliary stricture; therefore they were not treatment naive. High prevalence of CP-related strictures which are known to be more difficult to treat.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter V. Draganov | University of Florida | (352) 273-9472 | Peter.Draganov@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| 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 | up to 12 months |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stricture etiology | Number | participants |
|
| number of participants with history of prior stenting | Number | participants |
|
Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
|
|
| Primary | 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. | Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures. | Posted | Number | participants | at least 12 months after stent removal |
|
|
|
| Secondary | Number of Endoscopic Treatments Per Patient | The average number of ERCPs performed per patient required for resolution of benign strictures. | Posted | Mean | Full Range | endoscopic treatments | At time of procedure |
|
|
|
| Secondary | Ease of Stent Removal | The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed). | Posted | Number | participants | at time of procedure |
|
|
|
| Secondary | 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 | Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter. | Posted | Number | participants | up to 12 months |
|
|
|
| 0 |
| 23 |
| 9 |
| 23 |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Title | Measurements |
|---|---|
|
| All others |
|
| Failed |
|
| Title | Measurements |
|---|---|
|
| Complications during stent removal |
|
| upstream stent migration |
|