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Stents not superior to balloon dilation for dominant strictures in PSC

Short-term stents were not superior to balloon dilatation and correlated with a significantly higher rate of treatment-related severe adverse events among patients with primary sclerosing cholangitis and dominant strictures, according to recently published data.

“Endoscopic treatment of dominant strictures is efficacious in ameliorating symptoms in patients with PSC,” Cyriel Y. Ponsioen, MD, PhD, from the Academic Medical Center in Amsterdam, and colleagues wrote. “Balloon dilatation should be the initial treatment of choice for dominant strictures in PSC. This may be particularly relevant in patients with an intact papilla.”

Ponsioen and colleagues designed their study to compare short-term stenting with balloon dilation and determine the cumulative recurrence-free patency, safety and short-term improvement in cholestatic symptoms and biochemistry.

The researchers randomly assigned 65 patients in parallel groups during endoscopic retrograde cholangiopancreatography with a follow-up of 24 months.

At follow-up, the researchers found a similar cumulative recurrence-free rate of primary dominant strictures between the two groups. Overall median recurrence-free rates were 26 weeks (95% CI, 2.3-50) in the balloon dilation group and 34 weeks (95% CI, 4-64) in the short-term stent group.

Additionally, initial failure rates were similar between the balloon dilation group and short-term stent group (52% vs. 44%).

A total of 77% of patients experienced improvement in overall symptom scores at 3 months, including reduction in serum bilirubin, alkaline phosphatase and alanine aminotransferase.

However, the researchers noted that patients in the short-term stent group had a significantly higher risk for serious adverse events compared with the balloon dilation group (RR = 6.8; 95% CI, 1.7-27.4), predominantly driven by post-endoscopic retrograde cholangiopancreatography pancreatitis (14%).

“Our trial also yielded the first prospective data showing that both balloon dilatation and stenting of [dominant strictures] leads to amelioration of symptoms and significant decrease in cholestasis in the majority of patients at 3 months, strengthening the thus far low level of evidence on which the recent ... recommendations to perform therapeutic [endoscopic retrograde cholangiography] in symptomatic cases are based.” – by Talitha Bennett

Disclosure: Ponsioen reports he received grant support from Takeda; served on advisory boards for Takeda and AbbVie; and received speaker’s fees from Takeda, AbbVie and Dr. Falk Pharma. Please see the full study for the other authors’ relevant financial disclosures.