Primary percutaneous stenting above the ampulla for palliative biliary drainage of malignant hilar biliary obstruction.

Background: Unfortunately, most patients with a malignant perihilar obstruction are ineligible for surgery due to distant metastasis or locally advanced disease. A malignant hilar biliary obstruction (MHBO) can be caused by perihilar cholangiocarcinoma (pCCA), intrahepatic cholangiocarcinoma (iCCA), or gallbladder cancer (GBC). The key to successful palliative treatment is adequate biliary drainage to improve the patients wellbeing and to allow for palliative systemic therapy. Discussion remains whether an endoscopic or percutaneous biliary drainage approach is better.
Both endoscopic biliary drainage (EBD) and percutaneous drainage are mostly performed with stents or drains that not only cross the malignant obstruction but also the ampulla. This approach can cause bacterial colonization of the bile ducts and recurrent cholangitis often requiring multiple biliary re-interventions. As a result of these complications, 90-day mortality was 35% after initial palliative drainage in 186 patients with (suspected) unresectable pCCA in the Netherlands. In the Netherlands, only 7% of patients with pCCA become eligible for palliative systemic chemotherapy after drainage. Our hypothesis is that percutaneous placement of uncovered self expandable metal stents (SEMS) that do not cross the ampulla avoids disruption of the ampulla and thereby colonization of the bile ducts. To avoid bacterial colonization of the bile ducts with skin bacteria, no drain is left after primary percutaneous stenting (PPS).
Materials and Methods: Study design: A multicenter randomized controlled trial.
Study population: Patients with unresectable MHBO on imaging with histopathological confirmation and/or high clinical suspicion (as determined by the multidisciplinary hepatobiliary team) who did not undergo previous endoscopic or percutaneous drainage procedures and who have no signs of cholangitis.
Intervention arm: PPS bridging the malignant hilar obstruction with self-expandable metal stents without crossing the ampulla and without leaving an external drain after stent placement.
Standard arm: Endoscopic biliary drainage with bilateral plastic stents. No stent will be placed in one of the hemi livers when atrophic. When optimal drainage is reached, the plastic stents will be removed endoscopically and bilateral SEMS will be placed in a scheduled reintervention.
Results: Main study endpoints: