Ultrasound and Fluoroscopy Guided Percutaneous Transhepatic Biliary Drainage in Patients With Malignant Bile Duct Obstruction - Impact of Puncture Angle on Total Fluoroscopy Time Reduction
| Registry | NCT04653987 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 130 (Actual) |
| Sponsor | Institut za Rehabilitaciju Sokobanjska Beograd (Other); collaborators: Klinički centar Srbije |
| Conditions | Interventional Radiology |
| Interventions | Percutaneous biliary drainage (Procedure) |
| Dates | start 2016-01-01, primary completion 2020-10-01, completion 2020-11-01, first posted 2020-12-04, last updated 2020-12-04 |
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The purpose of this study is to retrospectively assess the importance of initial bile duct puncture angle on total fluoroscopy time and overall efficacy during ultrasound and fluoroscopy guided percutaneous transhepatic biliary drainage (PTBD) performed for patients with malignant biliary hilar obstruction.
Data used for this study will be collected from medical records of patients who underwent PTBD at the Interventional radiology department. Only patients who received percutaneous biliary drainage performed with right sided intercostal approach will be included in study. The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure was performed under fluoroscopy. The cumulative fluoroscopy time (the total time of the exposure to X rays during intervention) after the US guided puncture was recorded. It will be used as an indirect measure of the complexity of the intervention and as an important parameter of radiation exposure. The patients will be divided into two groups based on the puncture angle: ≤30° group and >30° group. The two groups will be retrospectively analysed for technical success, fluoroscopy time and complications.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Puncture angle : ≤30 (group I) >30 (group II) | Procedure: Percutaneous biliary drainage | The patients will be divided into two groups based on the puncture angle: ≤30° group and >30° group. The two groups will be retrospectively analyzed for technical success, fluoroscopy time and complications. | |
| Technical Parameters of all Interventions | Procedure: Percutaneous biliary drainage | Peripheral bile duct diameter, central bile duct diameter, number of punctures, type of drainage and total fluoroscopy time will be noted. |
Sex: All, ages: 18 Years to 90 Years
Inclusion Criteria: * pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1. Exclusion Criteria: * terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders