Endoscopic drainage of presumed resectable perihilar cholangiocarcinoma using a novel design short fully covered self-expanding metal stent with retrieval string (CHORDA)

Pre-operative biliary drainage is advised to treat obstructive jaundice and optimize the clinical condition of patients with presumed resectable perihilar cholangiocarcinoma who are expected to be eligible for major liver resection. However, stent related complications such as cholangitis (37%) and stent dysfunction (19%) occur frequently. Creating the need for numerous re-inventions, re-admissions, delay of diagnostic work-up and surgery. Biliary drainage could be optimized by the use of a novel design short fully covered self-expanding metal stent (FCSEMS) with a retrieval string, which makes removal possible although the stent does not reach into the duodenum. The feasibility and efficacy of the use of this stent in patients with presumed perihilar cholangiocarcinoma eligible for major liver resection will be studied in this prospective cohort pilot study of 20 patients.

It is hypothesized that endoscopic drainage could be optimized by the use of a novel design short fully covered self-expanding metal stent (FCSEMS) with a retrieval string, which makes removal possible although the stent does not reach into the duodenum. The relatively large diameter (6, 8, or 10mm instead of 2.3 - 3.3mm diameter of plastic stents), presumably leads to less stent occlusion and reduction in re- interventions. Secondly, because the stent does not bridge the papilla, risk of ascending cholangitis might be lower.

- Baseline: laboratory tests, questionnaires
- 7 days: laboratory tests, questionnaires, abdominal ultrasound
- 14 days: laboratory tests
- 28 days: questionnaires
- 90 days: questionnaires
- Every 3 months (as long as Kaffes biliary stent is in situ): consultation and stent exchange

*In patients who will not undergo exploratory laparotomy, the number of drainage-related complications will be measured until 7 days after the decision to cancel exploratory laparotomy or 90 days after inclusion, whichever comes first.

Unilateral endoscopic drainage of the future liver remnant using a removable FCSEMS (Niti-S Kaffes Biliary stent, TaeWoong Medical Co., Ltd., Seoul, Korea).