Distal Bile Duct Obstruction
Conditions
Keywords
pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice
Brief summary
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
Interventions
DEVICECovered Self-expanding metal biliary stents (C-SEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.
DEVICEUncovered Self-expanding metal biliary stents (U-SEMS)
Used for palliation of inoperable malignant distal bile duct obstructions.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice * 18 years of age or older * serum bilirubin \> 2mg/dL
Exclusion criteria
* prior endoscopic or percutaneous biliary drainage * post-surgical anatomy * primary site of biliary obstruction involving the common hepatic duct or hilum * tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Long-term Stent Failure | One year | Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Adverse Stent-related or Intervention-related Outcomes | One Year | Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from patient population at the Vanderbilt Digestive Disease Center. Between November 8, 2017 until June 14, 2019, only 6 participants were randomized and completed the study.
Pre-assignment details
4 participants screen failed before being randomized to either arm of the study. Only 6 participants was randomized (3 to each arm) and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| U-SEMS Group Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions. | 3 |
| C-SEMS Group Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | C-SEMS Group | Total | U-SEMS Group |
|---|---|---|---|
| Age, Continuous | 73 Years STANDARD_DEVIATION 0 | 73 Years STANDARD_DEVIATION 0 | 73 Years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 2 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Rate of Long-term Stent Failure
Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
Time frame: One year
Population: 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, none needed repeat intervention. Of the 3 participants in the C-SEMS group, 2 needed repeat intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| U-SEMS Group | Rate of Long-term Stent Failure | 0 Participants |
| C-SEMS Group | Rate of Long-term Stent Failure | 2 Participants |
Secondary
Rates of Adverse Stent-related or Intervention-related Outcomes
Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.
Time frame: One Year
Population: 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation. Of the 3 participants in the C-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| U-SEMS Group | Rates of Adverse Stent-related or Intervention-related Outcomes | 0 Participants |
| C-SEMS Group | Rates of Adverse Stent-related or Intervention-related Outcomes | 0 Participants |