Biliary Stricture, Biopsy Wound, Oncology
Conditions
Brief summary
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture
Detailed description
Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy
Interventions
PROCEDUREbiliary biopsy
biliary biopsy through a percutaneous approach during a percutaneous biliary drainage
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biliary strictures without histology available
Exclusion criteria
* Pregnant patients * Children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PTBD | 7 days | Efficacy of PTBD : bilirubinemia after PTFB at Day 7 |
| accuracy for percutaneous biliary biopsy (PTFB) | from baseline up to 1 month | Accuracy of PTFB : percentage of true positive and true negative results by pathologists |
| incidence of PTFB-related adverse events | up to 1 month after procedure | Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification |
Outcome results
None listed