Both biopsy techniques are equally feasible
ID
Bron
Verkorte titel
Aandoening
Indeterminate biliary stricture
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sensitivity, specificity and accuracy
Achtergrond van het onderzoek
Single-operator cholangioscopy has shown promising results for detection of cholangiocarcinoma in indeterminate biliary strictures, with higher sensitivity rates for diagnosis through direct stricture visualisation suggested as compared to targeted biopsies. Biopsy protocols and tissue sampling techniques such as bite-on-bite biopsies for diagnosing indeterminate biliary strictures have not yet been systematically investigated. The diagnostic accuracy of tissue sampling by taking multiple biopsies and using the bite-on-bite technique will be investigated
Doel van het onderzoek
Both biopsy techniques are equally feasible
Onderzoeksopzet
If benign pathology on biopsies, 1 year FU
Onderzoeksproduct en/of interventie
Multiple cholangioscopy-guided random biopsies and bite-on-bite(-on-bite) biopses of an indeterminate biliary stricture
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Male or female > 18 years old
- Presence of an indeterminate biliary stricture, defined as:
1. A bile duct stricture or filling defect of indeterminate nature after previous laboratory work-up, abdominal imaging (MRI, CT, endoscopic ultrasound) or ERCP, and/or;
2. Negative or inconclusive cytology or histology after ERCP with brush cytology or intra-ductal biopsies, and/or;
3. Despite benign cytology or histology findings persistent strong suspicion of a malignant aetiology based on clinical symptoms such as abdominal pain, unexpected weight loss, loss of appetite and obstructive jaundice.
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Contraindication for ERCP or SOC (i.e. suspicion of ascending cholangitis or of acute pancreatitis)
- Contraindication for biopsy (i.e. known coagulation disorder)
- No written informed consent
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9649 |
| Ander register | METC EMC : MEC-2018-1639 |