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Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage

NCT03546049 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-08-29

No results posted yet for this study

Summary

Prospective multi-site study of ultrasound-guided percutaneous biliary drainage and endoscopic ultrasound-guided biliary drainage with implantation of a self-expanding metal stent in patients with malignant, distal bile duct obstruction (PUMa-study)

Conditions

  • Bile Duct Obstruction, Extrahepatic

Interventions

PROCEDURE

US-guided percutaneous biliary drainage

Device: metal stent. The self-expandable metal stent is implanted percutaneously by a transhepatic access route. The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed). Length: 6-10 cm. Diameter: 8-10 mm.

PROCEDURE

EUS-guided biliary drainage

Device: metal stent. The transluminal (transgastric, transduodenal or transenteric) implanted self-expandable metal stent is released via echoendoscope. The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed) or mixed covered (one half covered, one half non-covered). The mixed covered stent is used for the transhepatic access. Length: 6-10 cm. Diameter: 8-10 mm.

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Theresienkrankenhaus und St. Hedwig-Klinik GmbH

    lead OTHER

Principal Investigators

  • Anja Sander, Dr.M.Sc. · Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2024-09-01
Completion
2024-12-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546049 on ClinicalTrials.gov