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Endosonography-guided biliary drainage (EUS-BD) in previously operated patients with malignant bile duct stenosis and frustrating ERC

Endosonography-guided biliary drainage (EUS-BD) in previously operated patients with malignant bile duct stenosis and frustrating ERC - EUS-BD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033178
Enrollment
150
Registered
2023-12-14
Start date
2005-07-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C20 C22 C23 C25 C78.7

Interventions

Group 1: Patients with cholestasis due to malignant biliary stenosis and post-operation with altered anatomy of the upper gastrointestinal tract who underwent EUS-BD after failed ERCP For this purpos
circulatory monitoring and EUS control), a wire was pushed through the puncture (hollow) needle into the bile ducts and through a tumor-related bile duct narrowing in order to lie down Remove the need

Sponsors

Klinik für Gastroenterologie, Hepatologie, Diabetologie und Allgemeine Innere Medizin (Innere Medizin II), o SRH Wald-Klinikum Gera
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with cholestasis secondary to malignant biliary stenosis and post-operation with altered anatomy of the upper GI tract who undergo EUS-BD after failed ERCP - consecutive patients

Exclusion criteria

Exclusion criteria: Patients with successful ERCP - without malignant obstruction of the biliary tract - with tumor lesions other than malignant liver or biliary tract tumors or pancreatic tumors or metastases - without prior surgery on the upper GI tract

Design outcomes

Primary

MeasureTime frame
- technical success rate, means successful stent implantation: Since the stent implantation is carried out interventionally and endosonographically, a successful stent implantation in each individual case must - as is the nature of the matter - also be checked with this method in terms of success control, i.e. intra-interventionally - a simultaneous X-ray fluoroscopy also confirms the correct placement already during the interventional endosonographic procedure. Furthermore, the correct stent placement is checked and documented post-interventionally with a transabdominal sonography follow-up on the first post-intervention day. The number of successful stent placements in relation to the total number of procedures results in the “technical success rate” in the calculation. - clinical success rate presented as laboratory and/or sonographic regression of cholestasis: It is shown with laboratory parameters that can be indicative of cholestasis, especially when elevated (e.g.: bilirubin, alkaline phosphatase; also increased transaminases such as ALAT / ASAT in the serum) and, when decreased, suggest regressed cholestasis. Here too, the cholestasis characteristics (width of the intra- and extrahepatic bile ducts as well as detectable air in the bile ducts as an indicator of successful bile duct drainage) are examined and documented post-interventionally with a transabdominal sonography follow-up on the 1st post-interventional day compared to pre-interventionally. The number of successful stent placements that can be characterized clinically (as explained above) in relation to the total number of procedures results in the “clinical success rate” in the calculation.

Secondary

MeasureTime frame
- Agreement rate between suspected imaging diagnosis and definitive histopathological diagnosis - Complication rate o Endoscopically manageable complication rate - Survival time o Factors influencing survival - Lethality

Countries

Germany

Contacts

Public ContactUwe Will

Klinik für Gastroenterologie, Hepatologie, Diabetologie und Allgemeine Innere Medizin (Innere Medizin II), SRH Wald-Klinikum Gera

uwe.will@srh.de+49-365-8282401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026