Comparing two methods for draining bile in patients with bile duct obstruction
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
This study is testing which method works better and is safer for draining bile in patients with a blocked bile duct caused by cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Theresienkrankenhaus und St. Hedwig-Klinik GmbH Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mannheim) |
| Trial ID | NCT03546049 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of ultrasound-guided percutaneous biliary drainage (PTBD) versus endoscopic ultrasound-guided biliary drainage (EUBD) in patients with malignant distal bile duct obstruction. The research aims to improve PTBD techniques by using color Doppler ultrasound for bile duct cannulation and accessing the bile duct from the left side of the liver to reduce complications. The study involves the implantation of a self-expanding metal stent in a single session to enhance clinical outcomes. It is a prospective multicenter study designed to provide insights into the optimal approach for biliary drainage.
Who should consider this trial
Good fit: Ideal candidates include patients with inoperable malignant disease causing extrahepatic bile duct obstruction who have had unsuccessful ERCP procedures.
Not a fit: Patients with operable malignant disease or those who can be treated with chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective biliary drainage methods for patients with bile duct obstruction.
How similar studies have performed: Previous studies have indicated that EUBD is generally favored over PTBD, but this study aims to refine PTBD techniques, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inoperable, malignant disease with extrahepatic bile duct obstruction (infra- hilar) * ERCP was not successful or wasn´t possible due to anatomical reasons (for example status post-gastrectomy) * At least twofold elevated bilirubin level (\> 2mg/dl) * Histologically verified malignant disease * Abdominal ultrasound was performed * Computed tomography or magnetic resonance imaging of the abdomen was performed * A written consent was given Exclusion Criteria: * Relevant blood coagulation disorder (Quick \< 50%, Partial thromboplastin time \> 50 sec., thrombocytes \< 50/nl) * Extrahepatic cholangiocellular carcinoma (Klatskin tumor) Bismuth II-IV or intrahepatic cholangiocellular carcinoma * Operable, malignant disease or disease which can be cured by chemotherapy (for example aggressive Non Hodgkin-lymphoma) * Pregnancy or breastfeeding * Participation in another trial concerning PTBD or EUBD
Where this trial is running
Mannheim
- Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital — Mannheim, Germany (Recruiting)
Study contacts
- Study coordinator: Daniel Schmitz, Dr.med.
- Email: d.schmitz@theresienkrankenhaus.de
- Phone: 00496214245575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.