, and colleagues reported in .
Patients with severe disease at baseline were more than twice as likely to develop a postprocedural stricture (odds ratio, 2.4). Longer baseline stricture length was less predictive, but it was still significantly associated with increased risk (OR, 1.2), according to Dr. Lakhtakia of the Asian Institute of Gastroenterology, Hyderabad, India, and coauthors.
The results indicate that indwelling biliary stenting is a reasonable and beneficial procedure for many of these patients, wrote Dr. Lakhtakia and coauthors.
“The major message to be taken from this study is that in patients with chronic [symptomatic] pancreatitis ... associated with benign biliary strictures, the single placement of a fully covered self-expanding metal stent for an intended indwell of 10-12 months allows more than 60% to remain free of symptoms up to 5 years later without additional intervention.”
The prospective nonrandomized study comprised 118 patients with chronic symptomatic pancreatitis and benign biliary strictures. All received a stent with removal scheduled for 10-12 months later. Patients were followed for 5 years. The primary endpoints were stricture resolution and freedom from recurrence at the end of follow-up.
Patients were a mean of 52 years old; most (83%) were male. At baseline, the mean total bilirubin was 1.4 mg/dL, and the mean alkaline phosphate level was 338.7 IU/L. Mean stricture length was 23.7 mm, but varied from 7.2 to 40 mm. Severe disease was present in 70%.
Among the cohort, five cases (4.2%) were considered treatment failures, with four lost to follow-up and one treated surgically for chronic pancreatitis progression. Another five experienced a spontaneous complete distal stent migration. The rest of the cohort (108) had their scheduled stent removal. At that time, 95 of the 118 experienced successful stent removal, without serious adverse events or the need for immediate replacement.
At 5 years, patients were reassessed, with the primary follow-up endpoint of stricture resolution. Secondary endpoints were time to stricture recurrence and/or changes in liver function tests. Overall, 79.7% (94) of the overall cohort showed stricture resolution at 5 years.
Among the 108 who had a successful removal, a longer time of stent indwell was associated with a decreased chance of recurrent placement. Among those with the longer indwell (median, 344 days), the risk reduction was 34% (OR, 0.66). Of the 94 patients with stricture resolution at stent removal, 77.4% remained stent free at 5 years.
At the end of follow-up, 56 patients had symptomatic data available. Most (53) had not experienced symptoms of biliary obstruction and/or cholestasis. The other three had been symptom free at 48 months but had incomplete or missing 5-year data.
By 5 years, 19 patients needed a new stent. Of these, 13 had symptoms of biliary obstruction.
About 23% of stented patients had a stent-related serious adverse event. These included cholangitis (9.3%), abdominal pain (5%), pancreatitis (3.4%), cholecystitis (2%), and cholestasis (1.7%).
About 80% of the 19 patients who had a stricture recurrence experienced a serious adverse event in the month before recurrent stent placement. The most common were cholangitis, cholestasis, abdominal pain, and cholelithiasis.
In a univariate analysis, recurrence risk was significantly associated with severe baseline disease and longer stricture length. The associations remained significant in the multivariate model.
“Strikingly, patients with initial stricture resolution at [stent] removal ... were very likely to have long-term stricture resolution” the authors noted.
Dr. Lakhtakia had no financial disclosures.
SOURCE: Lakhtakia S et al. Gastrointest Endosc. 2019. .