Bioresorbable stents safe and effective for benign biliary strictures

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Giovanni Mauri, Milan, Italy, reported the results of the study on the treatment of benign biliary strictures with a novel bioresorbable biliary stent, EllaDV (Ellacs) at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria).

Mauri told Interventional News: “Bioresorbable biliary stents are important because they offer an additional treatment option for patients in whom standard treatments (bilioplasty or sustained dilation) have failed, potentially sparing a surgical re-operation. Degradation of the stent occurs by hydrolysis in about six months and the radial strength is reduced by 50% in about six to eight weeks.”

Biliary strictures represent a frequent complication of surgical procedures involving the biliary tract. In order to avoid the invasiveness of a re-operation, endoscopical and percutaneous treatments are generally used as a first option. When endoscopy is not feasible, percutaneous strategies remain the only non-surgical option for repair. However, with this strategy, stricture recurrences are fairly frequent, and patients have to carry an external drain for a long period (often several months).

Mauri said: “Implantation of a stent at the level of the stenosis offers the advantage of a sustained dilation effect with a higher expansion force compared to bilioplasty and biliary drainage. Successful attempts have been made with the use of retrievable covered metal stents in the treatment of benign biliary stenosis. However, as the access to the biliary tree has to be maintained for subsequent removal of the stent, even when retrievable stents are used, the patient has to carry an external drain for a long period. Bioresorbable biliary stents seem to offer an advantage in stenting, avoiding the problems related with subsequent stent removal, and with the advantage of an early completion of the whole procedure. After bioresorbable stent implantation, external drainage is kept in place for about 24 or 48 hours. For this reason we think that implantation of a bioresorbable in the future may be considered not only an effective option when other strategies have failed, but could also be used as an alternative first option in order to spare the patient the discomfort of a long-period external drainage.”

 

The investigators, from 10 centres experienced in percutaneous treatment of biliary disease, retrospectively evaluated data from 59 patients (35 [59.3%] males, age 56.8 ± 18.9 years) who were treated with the bioabsorbable EllaDV stent (n=67) to treat benign biliary strictures refractory to standard bilioplasty. They evaluated the technical success (correct implantation of the stent as preoperatively planned), clinical effectiveness (resolution of the clinical problem), immediate or late complications, and rate of restenosis at follow-up.

Mauri and colleagues observed that the procedure was successfully performed in 58/59 patients (technical success 98.3%). In one case, a malpositioning of the stent during the procedure occurred.

“The procedure was also clinically effective in all cases. There were four (6.8%) immediate complications, including malpositioning and three mild haemobilia that resolved spontaneously. No late complications related to the stent positioning occurred. At a mean follow-up time of 23.2 ± 15.1 months (mean ± standard deviation), there were 11 (18.6%) cases of restenosis, with a mean time to restenosis of 16.2 ± 8.2 months (mean ± standard deviation),” said Mauri.