Evaluating the success of different biliary drainage procedures
Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures
Theresienkrankenhaus und St. Hedwig-Klinik GmbH · NCT05268731
This study is testing if measuring GGT levels after a biliary drainage procedure can better show how well the treatment worked compared to looking at bilirubin levels, helping doctors make better decisions for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Theresienkrankenhaus und St. Hedwig-Klinik GmbH (other) |
| Locations | 1 site (Schwerin) |
| Trial ID | NCT05268731 on ClinicalTrials.gov |
What this trial studies
This study analyzes the clinical success of percutaneous transhepatic biliary drainage (PTBD) procedures by measuring serum bilirubin and gamma-glutamyl transferase (GGT) levels in patients post-procedure. It involves a systematic review of medical records from patients who underwent technically successful PTBD over a 20-year period. The study aims to determine if GGT levels can serve as a more reliable indicator of success compared to bilirubin levels, potentially influencing patient discharge times and improving comparisons with other drainage methods.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone a technically successful percutaneous transhepatic biliary drainage procedure.
Not a fit: Patients who have not had a technically successful PTBD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment of biliary drainage procedures, enhancing patient outcomes and discharge processes.
How similar studies have performed: While the approach of using GGT as a success indicator is novel, similar studies have shown the importance of alternative biomarkers in assessing treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * technically successful PTBD Exclusion Criteria: * technically not successful PTBD
Where this trial is running
Schwerin
- Helios Kliniken Schwerin — Schwerin, Germany (RECRUITING)
Study contacts
- Principal investigator: Daniel Schmitz, MD — Theresienkrankenhaus Mannheim, University of Heidelberg
- Study coordinator: Dr.med. D Schmitz, MD
- Email: s.daniel_427@gmx.de
- Phone: +49491758674415
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.
Conditions: Extrahepatic Cholestasis, Self Expandable Metallic Stents, Drainage