Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study

Perihilar cholangiocarcinoma (pCCA) is a rare tumour originating in the bile
ducts at the liver hilum. These patients present with jaundice due to biliary
obstruction and 25% are eligible for a curative-intent major liver resection.
Preoperative biliary drainage is required to resolve the biliary obstruction,
because without drainage the liver cannot regenerate after a major liver
resection, resulting in postoperative liver failure and mortality.

Dutch and international guidelines recommend an endoscopic approach for biliary
drainage. An endoscopic stent in the bile duct crosses not only the tumor, but
also the ampulla, which is a sphincter that keeps enteral contents out of the
biliary tree. A stent that crosses the ampulla causes bacterial colonization of
the previously sterile intrahepatic bile ducts. Recurring cholangitis often
develops, requiring multiple reinterventions, hospital admissions, clinical
deterioration, and even death in many patients. In a Dutch multicenter RCT (the
DRAINAGE trial), this approach was compared with percutaneous biliary drainage.
Unfortunately, percutaneous drainage was not better, probably because the
percutaneous drain also crosses the ampulla.

The potential solution to this clinical problem is primary percutaneous
stenting. Fenestrated self-expandable metal stents (SEMS) are used that do not
cross the ampulla, avoiding bacterial colonization of the bile ducts. Moreover,
no external percutaneous biliary drain is used, avoiding bacterial colonization
of the bile ducts with skin bacteria. In the TESLA trial (MEC-2019-0789), we
have used this approach in 35 patients who were ineligible for resection.
Compared to a historical cohort with endoscopic drainage, we found a
substantial decrease in 90-day mortality from 35% to 7% and a cost saving of
about 8,000 euro per patient in the first 90-days. Primary percutaneous
stenting has never been investigated in resectable pCCA.

To analyse complications due to primary percutaneous stenting in patients with
resectable pCCA.

We aim to perform a proof-of-concept pilot study at Erasmus MC, including 12
patients. The expected inclusion period is less than 2 years, based on
historical annual volume and accrual proportion of eligible patients in the
TESLA trial for unresectable pCCA.

Primary percutaneous stenting with fenestrated self-expandable metal stents
(SEMS) without crossing the ampulla and without leaving an external drain after
stent placement.

Primary percutaneous stenting is an alternative approach to the standard of
care, which is endoscopic biliary drainage. Complications due to the
transhepatic biliary drainage, i.e. bleeding, infection and bile leakage are
uncommon (<5%).
We hypothesize that PPS in patients with resectable pCCA minimizes
post-drainage cholangitis and mortality, requires fewer reinterventions, and
increases the rate of patients receiving a curative-intent resection.
In this study, patients will undergo an invasive procedure with hospital
discharge the next day. This corresponds to the standard of care. Follow-up is
planned after 14 days (+/- 4 days), according to standard of care.