MPS and FCSEMS Feature Similar Efficacy, Safety Over 2 Years in Chronic Pancreatitis Benign Biliary Strictures

Multiple plastic stents (MPS), when used as endotherapy for benign biliary strictures (BBS) associated with chronic pancreatitis (CP), feature similar safety and efficacy profiles as a single, fully covered self-expanding metal stent (FCSEMS). However, the use of a FCSEMS may be associated with a lower need for endoscopic retrograde cholangiopancreatography (ERCP) procedures over 2 years following initial stenting, according to a study in Gastroenterology.

This open-label, multicenter study randomized 164 patients with CP-associated BBS (median age, 52 years) to either MPS (n=84) or FCSEMS (n=80). At baseline, the median duration since initial CP diagnosis was 1.9 years. Approximately 43.9% of patients presented with a prior single plastic stent indwelling.

During the 12-month treatment period, patients in the MPS arm had 3 or 4 side-by-side MPS stenting procedures. In the FCSEMS group, patients received a single 8 mm or 10 mm diameter FCSEMS. The investigators compared the 2 groups in terms of the resolution of biliary strictures at 24 months following initial stent(s) placement. This primary clinical outcome was defined as the absence of re-stenting following the stenting period, as well as a 2-year serum alkaline phosphatase level not exceeding approximately twice the level at the stenting period’s end.

The baseline technical success rates were 97.6% and 98.6% for MPS and FCSEMS groups, respectively (P =.99). A total of 11 patients crossed over from the MPS to the FCSEMS arm, and 10 patients from the FCSEMS group crossed over to MPS.

At 2 years, the stricture resolution status was 77.1% for MPS vs 75.8% for FCSEMS (P =.008). The mean number of required ERCPs during the study was significantly lower in the FCSEMS arm (intention-to-treat, 2.6±1.3 vs 3.9±1.3; P <.001). Additionally, a significantly fewer number of stents were placed in the FCSEMS group during the study period (as-treated, 1.3±0.6 vs 7.0±4.4; P <.001).

There was no difference between the MPS and FCSEMS groups in regard to the proportion of patients who experienced a serious adverse event (SAE) during the study (19.0% vs 23.8%, respectively; P =.568). The most common SAEs were cholangitis/fever/jaundice, abdominal pain, cholecystitis, and post-ERCP pancreatitis. The researchers observed no incidences of stent- or procedure-related deaths in either group.

A limitation of the study included the crossover of 13% of the cohort during follow up, which the investigators noted may have altered the balance of baseline risk across treatment groups.

These findings provide more insight into the different management strategies for CP-associated strictures, which remains of clinical importance, considering these “strictures may be more resistant to treatment because of the chronic nature of the insult and to the fibrotic nature of the strictures in calcifying CP,” the researchers wrote.

Disclosure: This clinical trial was supported by Boston Scientific. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Ramchandani M, Lakhtakia S, Costamagna G, et al. Fully covered self-expanding metal stent versus multiple plastic stents to treat benign biliary strictures secondary to chronic pancreatitis: a multicenter randomized trial. Published online March 16, 2021. Gastroenterol. doi: 10.1053/j.gastro.2021.03.015