Common Bile Duct Stricture
Conditions
Keywords
stenosis, bile duct, chronic pancreatitis, postoperative, post-liver transplant
Brief summary
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
Detailed description
Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).
Interventions
DEVICEFully covered Metallic Stent
Covered Wallflex Biliary (TM)
DEVICEPlastic Stent
Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing ERCPs, until the stricture has been obliterated using clinical and fluoroscopic criteria.
Sponsors
American Society for Gastrointestinal Endoscopy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bismuth Type I benign bile duct stricture * Objective signs/symptoms related to the stricture
Exclusion criteria
* Suspected malignant etiology for the stricture * Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (\< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy * Bismuth Type II-IV stricture * Proximal common hepatic duct diameter \< 6 mm * Intact gallbladder, except in cases where a stent can be deployed \> 1cm below the cystic duct insertion * Age \< 18 years, pregnancy, incarceration, inability to provide informed consent * Karnofsky score ≤ 40 * Inability to pass a guidewire proximal to the stricture * Stricture \> 8cm in length * Life expectancy \< 1 year * Concomitant nonanastomotic biliary strictures or biliary casts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Clinical Success | Post-stent removal (up to one year after enrollment) | Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fully Covered Metallic Stent Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM) | 57 |
| Plastic Stent Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria. | 55 |
| Total | 112 |
Baseline characteristics
| Characteristic | Fully Covered Metallic Stent | Plastic Stent | Total |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.4 | 56.7 years STANDARD_DEVIATION 11 | 55.9 years STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 57 | 8 / 55 |
| serious Total, serious adverse events | 14 / 57 | 9 / 55 |
Outcome results
Primary
Early Clinical Success
Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.
Time frame: Post-stent removal (up to one year after enrollment)
Population: The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fully Covered Metallic Stent | Early Clinical Success | 50 Participants |
| Plastic Stent | Early Clinical Success | 41 Participants |