Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial | Hepatobiliary Disease | JAMA | JAMA Network
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Original Investigation
March 22/29, 2016

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Medicine, Indiana University School of Medicine, Indianapolis
  • 2Department of Medicine, Medical University of South Carolina, Charleston
  • 3Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • 4Methodist Dallas Medical Center, Dallas, Texas
  • 5Department of Medicine, Washington University in St Louis, St Louis, Missouri
  • 6Department of Medicine, University of Michigan, Ann Arbor
  • 7Royal Wolverhampton Trust, Wolverhampton, United Kingdom
  • 8Center for Endoscopic Research and Therapeutics, University of Chicago School of Medicine, Chicago, Illinois
  • 9Department of Biostatistics, Indiana University School of Medicine, Indianapolis
JAMA. 2016;315(12):1250-1257. doi:10.1001/jama.2016.2619

Importance  Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.

Objective  To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution.

Design, Setting, and Participants  Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded.

Interventions  Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence.

Main Outcomes and Measures  Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%.

Results  There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001).

Conclusions and Relevance  Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these.

Trial Registration  clinicaltrials.gov Identifier: NCT01221311