Project on EUS- BD
Research type
Research Study
Full title
Proof of Concept Study: Safety and Feasibility Study of Lumen-Apposing Stents (LAMS) in EUS-Guided Biliary Drainage
IRAS ID
237130
Contact name
Suresh Vasan Venkatachalapathy
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
ISRCTN Number
ISRCTN13196704
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Summary of Research
Obstructive Jaundice due to cancerous blockage of the bile duct is often difficult to treat and patients suffer from itching, sleeplessness, infections and are unable to receive alternative treatments such as chemotherapy. Delay in treatment of cancer often has adverse outcomes. Hence, facilitating drainage of the bile duct and relieving jaundice is an important step in the management of patients with malignant obstruction.Endoscopic retrograde cholangio-pancreatography (ERCP-Endoscopy procedure) with insertion of metal stent (pipe) is the conventional way to treat the bile duct blockage. However, it is only successful in 80% of the time. Hence, one in five patients require alternative mode of drainage. An alternative mode is to do a drain the bile duct through the liver (approaching from the side of the lower chest) under X-ray guidance (Percutaneous trans-hepatic cholangiogram (PTC). This procedure is generally successful in draining bile, but is associated with pain, serious adverse events in 3 out of 10 patients and 1 in 5 die as a consequence.
EUS-BD is an endoscopic procedure where the bile duct is identified under endoscopic ultrasound (EUS) guidance through the small bowel and a stent deployed in between the bile duct and small bowel. A new lumen apposing metal stent is now available for use and it is likely to have less adverse events compared to PTC. Hence we propose a prospective observational study to assess the safety and success of this new method.
Summary of Results
Background and Aims: Biliary drainage with ERCP is successful in only 80% to 90% of cases of extrahepatic cholangiocarcinoma and pancreatic cancer. We present the results of a multicenter prospective study assessing the safety, feasibility, and quality of life of patients after EUS-guided biliary drainage (EUS-BD) with lumenapposing metal stents after failed ERCP.
Methods: All consecutive adults with a dilated common bile duct (CBD) 14 mm secondary to inoperable malignant distal CBD stricture and failed ERCP biliary drainage were screened and recruited from 3 tertiary UK centers.
Technical success of EUS-BD using lumen-apposing metal stents was the primary endpoint. Improvement in serum bilirubin level, 30-day mortality, procedure-related adverse events, and quality of life were secondary endpoints.
Improvement in quality of life was measured using a validated questionnaire (EORTC QLQ-BIL21).
Results: Twenty patients were included in the analysis. EUS-BD was technically successful in all patients and the clinical success rate was 95% (19 of 20) at day 7 (>50% reduction in bilirubin level) and 92.3% (12 of 13) at day 30 (bilirubin <50 mmol/L). There were significant improvements in overall quality of life score (49 vs 42, P Z .03) at day 30. All-cause 30-day mortality was 20% and the moderate adverse event rate was 10% (1 cholangitis and 1 stent migration).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0255
Date of REC Opinion
9 Oct 2018
REC opinion
Further Information Favourable Opinion