Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.
Cote GA, Slivka A, et al.JAMA 2016; 315(12): 1250-1257.
Aims
To determine whether self-expandable metallic stents (cSEMS) would be noninferior to multiple plastic stents in the first-line endoscopic treatment of benign bile duct strictures.
Interventions
Participants were randomized to receive either a plastic stent or cSEMS.
Participants
112 patients with a benign bile duct stricture located at least 2 cm below the hepatic confluence and coupled with related signs or symptoms.
Outcomes
The primary outcome measured was stricture resolution rate. Secondary measured outcomes included technical success, recurrence rates, safety and the requisite number of endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.
Follow-up
12 months
CET Conclusions
This is a well written report of a good quality clinical trial, however it should be noted that not all of the patients included were transplant recipients. It was randomized although a degree of blocking was used to spread allocations between the centres. There was no blinding as two different endoscopic techniques were employed. The study had a non-inferiority design, as the authors supposed that if metallic stenting was equivalent to plastic stenting then the reduced frequency of ERCP required with metal stents would provide the overall benefit of metal stents. In summary covered, self-expanding metallic stents were non-inferior to plastic stents when used as the initial treatment of benign biliary strictures, with a lower number of ERCPs required to achieve resolution. The follow up period of 12 months may be too short for determining if there is any difference in stricture recurrence rates.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01221311