Biliary Stricture, Biliary Tract Diseases, Cholangiocarcinoma, Cholangiopancreatography, Endoscopic Retrograde
Conditions
Brief summary
The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years * Diagnosis of indeterminate biliary stricture * Scheduled clinically indicated ERCP procedure
Exclusion criteria
• Adults \<18 years, Children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Characteristics | 1 year after ERCP procedure | Accuracy, Sensitivity, Specificity for the detection of malignancy with each sampling technique. Accuracy was calculated as \[(true positives + true negatives)/ (true positives + true negatives + false positives + false negatives)\] x100 and reported as a percentage. Sensitivity was calculated as \[true positive/(true positive + false negative)\] x100 and reported as a percentage. Specificity was calculated as \[true negatives/(true negatives +false positives)\] x100 and reported as a percentage. |
| Number of Adverse Events | Within 30 days of ERCP procedure | Adverse events after biliary sampling |
| Positive and Negative Predictive Value | 1 year after ERCP procedure | Positive Predictive Value calculated as number of true positives divided by the sum of true positives and false positives, expressed as a percentage. Negative predictive value calculated as the number of true negatives divided by the sum of true negatives and false negatives, expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | through study completion, an average of 2 years | Number of ERCPs, Radiological studies etc needed before accurate diagnosis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVinay Chandrasekhara, MD
Mayo Clinic
Participant flow
Recruitment details
Adult patients ≥ 18 years of age undergoing ERCP for a biliary stricture were enrolled in the study at the time of ERCP between October 2020 and February 2022.
Pre-assignment details
Patients meeting eligibility criteria were included in a single cohort.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 16.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 318 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Malignant strictures | 93 Patients with malignant stricture |
| Primary Sclerosing Cholangitis | 130 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 306 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 327 |
| other Total, other adverse events | 0 / 327 |
| serious Total, serious adverse events | 0 / 327 |
Outcome results
None listed