The procedure can be beneficial prior to chemotherapy, but it also has high rates of complications, this new analysis shows.
People with unresectable perihilar cholangiocarcinoma (pCCA) can find relief from symptoms if they undergo a biliary drainage procedure, but new study findings show the procedures is often unsuccessful, with a 90-day mortality rate of more than one-third of patients.
In a new article in the journal Surgery, investigators called for more research to find ways to improve outcomes from the procedure.
Most patients with pCCA have unresectable tumors by the time they receive their diagnosis. In many cases, they seek medical attention because of jaundice associated with tumor-related biliary obstruction. The jaundice and associated liver dysfunction can be relieved through biliary drainage, which the study authors said is typically performed either endoscopically or percutaneously.
Unfortunately, the intervention primarily improves symptoms. The median overall survival (OS) of people with unresectable cases is 6 months. Palliative systemic chemotherapy is an option in patients with bilirubin levels below 50 mcmol/L, and biliary drainage can be used to lower bilirubin levels to make patients eligible for chemotherapy. However, chemotherapy only extends median OS by about 3 months, the authors noted.
Previous research has looked at outcomes of patients undergoing biliary drainage whose tumors were deemed resectable, but the investigators said it is also important to know the difference biliary drainage can make in the more challenging scenario of an unresectable tumor.
“Patients often have complications after initial biliary drainage (eg, cholangitis), and reinterventions are frequently needed because of inadequate biliary drainage,” they said. “The goal of initial biliary drainage is to avoid complications and reinterventions, as well as allow for early initiation of systemic chemotherapy.”
To better understand the success rate of biliary drainage in cases of unresectable pCCA, the investigators retrospectively analyzed 186 patients who underwent initial biliary drainage between 2002 and 2014 at multiple medical centers. Eighty-even percent of these patients underwent endoscopic procedures; the remaining patients had percutaneous drainage procedures.
Most procedures in both categories were unsuccessful. Only 45% of the endoscopic biliary drainage procedures were successful, and just 6 of the 25 patients undergoing percutaneous procedures experienced success.
“The reasons for an unsuccessful initial drainage were: the failure to place a drain or stent in 39 patients (21%), an unplanned reintervention within 14 days in 52 patients (28%), and the bilirubin level > 50 mcmol/L (or not halved) after 14 days of initial drainage in 16 patients (9%),” the study authors wrote.
In both patient cohorts, 12% experienced severe complications, including new-onset cholangitis, acute pancreatitis, and bile duct injury. Thirty-six percent of patients did not survive 90 days following the procedure. The median OS in the cohort was 6.7 months.
The authors noted that most of the patients who died did not appear to have metastatic disease. “Inadequate biliary drainage and complications of biliary drainage, leading to cholangitis and clinical deterioration, appear to be the root cause of 90-day mortality in these patients,” they wrote.
They said it has been difficult to assess the efficacy of biliary drainage procedures because previous studies have used different metrics of success, such as successful stent placement or bilirubin reduction. They said more research is needed to improve outcomes, but they said that will be a difficult task.
“Randomized trials for initial biliary drainage remain challenging as demonstrated by a multicenter study that was closed early because of lack of accrual,” they wrote.
In the meantime, the authors said outcomes might be improved by more widespread adoption of the European Society of Gastrointestinal Endoscopy guidelines, which call for “more liberal use of metal stents and placement of bilateral stents at initial biliary drainage.” They added that another study is currently examining whether initial percutaneous placement of a metal stent that does not cross the ampulla might help avoid contamination and improve outcomes.
Keulen A, Gaspersz M, van Vugt J et al. Success, complication, and mortality rates of initial biliary drainage in patients with unresectable perihilar cholangiocarcinoma. Surgery. Published online August 18, 2022. doi:10.1016/j.surg.2022.06.028