TESLA RCT
The Dutch TESLA trial randomises people whose bile ducts are blocked high in the liver by an unremovable tumour, including gallbladder cancer, to a stent placed through the skin and left above the duodenum or to the usual endoscopic drainage, counting major complications over 90 days.
Overview
TESLA (NCT06671418) is a randomised trial at Erasmus MC for patients with unresectable malignant hilar biliary obstruction from non-resectable cholangiocarcinoma, gallbladder cancer or liver metastases. Patients are randomised to primary percutaneous stenting with a metal stent placed above the ampulla, avoiding the duodenal reflux and cholangitis of transpapillary stents, or to endoscopic biliary drainage. The primary endpoint is major complications within 90 days of randomisation; 148 patients are planned, the trial opened in August 2023 by invitation and lists primary completion in November 2027. Gallbladder cancer invading the hilum is a common cause of this presentation, and the trial addresses the unresolved percutaneous versus endoscopic question after the INTERCPT trial closed for slow accrual.
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