Temporary placement of a fully covered self-expanding metal stent (FCSEMS) may be an effective first-line treatment for chronic pancreatitis (CP)-associated symptomatic benign biliary strictures (BBSs), according to study results published in Gastrointestinal Endoscopy.
CP is a progressive disease associated with impaired serious outcomes including biliary strictures occurring in 3% to 46% of patients. Endoscopic therapy is frequently used as a first-line therapy for CP-related BBSs, MPS insertion and temporary FCSEMS placement being the 2 endoscopic options. However, endoscopic therapy is found to be associated with reduced compliance, high costs, and high burden of treatment. FCSEMS may be a more desirable long-term treatment for CP-associated BBSs due to fewer interventions and reduced morbidity rates. The objective of this study was to assess long-term outcomes in CP-associated BBSs following the placement and removal of FCSEMS.
In this open-label, multinational, nonrandomized prospective study, researchers examined 118 patients with CP and BBS aged 18 and older who were treated with FCSEMS with scheduled removal at 10 to 12 months. All patients were followed for 5 years after FCSEMS indwell to determine treatment efficacy. The primary end point for this follow-up study was stricture resolution defined as being stent-free from the time of initial removal without signs of biliary obstruction. The secondary end point was time to stricture recurrence in patients with initial stricture resolution following FCSEMS indwell, which was assessed by symptoms of biliary obstruction and changes in liver function tests.
Kaplan-Meier estimates were calculated for the cumulative probability of freedom from recurrent stent placement for up to 5 years following FCSEMS indwell. Analyses were performed on patients who received an FCSEMS and followed with the intention to remove the FCSEMS endoscopically after 10 to 12 months of indwell.
Results revealed that overall, 79.7% of patients experienced stricture resolution at either stent removal or at the time of observation of complete distal migration. Increased FCSEMS indwell duration was associated with a reduced risk for recurrent stent placement (hazard ratio [HR], 0.66; 95% CI, 0.54-0.82; P <.001) in patients who had endoscopic stent removal.
Results from Kaplan-Meier analyses revealed that 61.6% (95% CI, 52.5%-70.7%) of patients were stent-free at 75 months following FCSEMS placement, and that of the patients who had stricture resolution at endoscopic FCSEMS removal or observation of complete distal migration (n=94), 77.4% (95% CI, 68.4%-86.4%) remained stent-free. Serious adverse events occurred in 22.9% of patients, all of which were resolved using repeated endoscopy or medical therapy. Results from multivariate analyses revealed that predictors of stricture recurrence were severe CP (HR, 2.4; 95% CI, 1.0-5.6; P =.046) and longer stricture length (HR, 1.2; 95% CI, 1.0-1.4; P =.022).
This study had 2 main limitations. First, there was no control group available for comparison, and second, cessation or continuation of alcohol consumption and/or smoking during follow-up was not documented.
The study researchers concluded that endoscopic biliary drainage with temporary FCSEMS placement be considered a first-line therapy for CP-associated BBS, and that surgery should still be considered in patients who fail stricture resolution following 1 year indwell.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Lakhtakia S, Reddy N, Dolak W, et al. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis [published online September 5, 2019]. Gastrointest Endosc. doi: 10.1016/j.gie.2019.08.037