C20 C22 C23 C25 C78.7
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Klinik für Gastroenterologie, Hepatologie, Diabetologie und Allgemeine Innere Medizin (Innere Medizin II), SRH Wald-Klinikum Gera