Benign Biliary Strictures
Conditions
Brief 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.
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.
Interventions
PROCEDUREEndoscopic Retrograde Cholangiopancreatography (ERCP)
Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years or older 2. Subject has benign biliary stricture 3. Subject must be able to give informed consent
Exclusion criteria
1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP) 2. The subject is unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Term Success Rate in the Resolution of Biliary Strictures | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Endoscopic Treatments Per Patient | At time of procedure | The average number of ERCPs performed per patient required for resolution of benign strictures. |
| Ease of Stent Removal | at time of procedure | The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed). |
| Frequency and Severity of Adverse Events (Including Stent Migration) | up to 12 months | Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Benign Biliary Strictures Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| <12 Months Post Stent Removal | Lost to Follow-up | 4 |
| <12 Months Post Stent Removal | persistent stricture after stenting | 1 |
Baseline characteristics
| Characteristic | Benign Biliary Strictures |
|---|---|
| Age, Customized | 60 years |
| number of participants with history of prior stenting number with no history of stenting | 10 participants |
| number of participants with history of prior stenting number with prior stenting | 13 participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
| Stricture etiology Chronic pancreatitis (CP) | 14 participants |
| Stricture etiology Gallstone related | 1 participants |
| Stricture etiology Idiopathic | 4 participants |
| Stricture etiology Orthotopic liver transplantation (OLT) | 4 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
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.
Time frame: at least 12 months after stent removal
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benign Biliary Strictures | Long-term Success Rate in Resolution of Biliary Strictures | Overall | 15 participants |
| Benign Biliary Strictures | Long-term Success Rate in Resolution of Biliary Strictures | Chronic pancreatitis (CP) | 8 participants |
| Benign Biliary Strictures | Long-term Success Rate in Resolution of Biliary Strictures | Orthotopic liver transplantation (OLT) | 3 participants |
| Benign Biliary Strictures | Long-term Success Rate in Resolution of Biliary Strictures | All others | 4 participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benign Biliary Strictures | Short Term Success Rate in the Resolution of Biliary Strictures | Overall | 22 participants |
| Benign Biliary Strictures | Short Term Success Rate in the Resolution of Biliary Strictures | Chronic pancreatitis (CP) | 14 participants |
| Benign Biliary Strictures | Short Term Success Rate in the Resolution of Biliary Strictures | Orthotopic liver transplantation (OLT) | 3 participants |
| Benign Biliary Strictures | Short Term Success Rate in the Resolution of Biliary Strictures | All others | 5 participants |
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).
Time frame: at time of procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benign Biliary Strictures | Ease of Stent Removal | With ease | 21 participants |
| Benign Biliary Strictures | Ease of Stent Removal | Mild difficulty | 0 participants |
| Benign Biliary Strictures | Ease of Stent Removal | Significant difficulty | 2 participants |
| Benign Biliary Strictures | Ease of Stent Removal | Failed | 0 participants |
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
Time frame: up to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benign Biliary Strictures | Frequency and Severity of Adverse Events (Including Stent Migration) | Downstream Stent Migration | 5 participants |
| Benign Biliary Strictures | Frequency and Severity of Adverse Events (Including Stent Migration) | Postprocedure pain due to expansion force of SEMS | 1 participants |
| Benign Biliary Strictures | Frequency and Severity of Adverse Events (Including Stent Migration) | Complications during stent placement | 0 participants |
| Benign Biliary Strictures | Frequency and Severity of Adverse Events (Including Stent Migration) | Complications during stent removal | 0 participants |
| Benign Biliary Strictures | Frequency and Severity of Adverse Events (Including Stent Migration) | upstream stent migration | 4 participants |
Secondary
Number of Endoscopic Treatments Per Patient
The average number of ERCPs performed per patient required for resolution of benign strictures.
Time frame: At time of procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Benign Biliary Strictures | Number of Endoscopic Treatments Per Patient | 2.4 endoscopic treatments |