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Randomized Controlled Trial
. 2016 Mar;315(12):1250-7.
doi: 10.1001/jama.2016.2619.

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

Gregory A Coté  1 , Adam Slivka  2 , Paul Tarnasky  3 , Daniel K Mullady  4 , B Joseph Elmunzer  5 , Grace Elta  6 , Evan Fogel  7 , Glen Lehman  7 , Lee McHenry  7 , Joseph Romagnuolo  8 , Shyam Menon  9 , Uzma D Siddiqui  10 , James Watkins  7 , Sheryl Lynch  7 , Cheryl Denski  11 , Huiping Xu  11 , Stuart Sherman  7
Affiliations
Randomized Controlled Trial

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

Gregory A Coté et al. JAMA. 2016 Mar.

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Coté reported having been a consultant for Boston Scientific, Cook Medical, and Olympus America. Dr Slivka reported having been a consultant for and having received grants from Boston Scientific and having received other support from Mauna Kea Technology and Pinnacle Biologics. Dr Tarnasky reported having been a speaker and consultant for Boston Scientific. Dr Elta reported having been a consultant for Olympus Medical. Dr Lehman reported having received grants or other support from Cook Endoscopy, Olympus, Boston Scientific, and Medigus. Dr McHenry reported having received grants or other support from Cook and Conmed. Dr Romagnuolo reported having received a grant for his institution from the American Society for Gastrointestinal Endoscopy. Dr Sherman reported having received support from Boston Scientific and Olympus. No other disclosures were reported.

Figures

Figure 1
Figure 1. Patient Flow Through the Biliary Stent Trial
cSEMS indicates fully covered, self-expandable metallic stent.
Figure 2
Figure 2. Time to Stricture Resolution
cSEMS indicates fully covered, self-expandable metallic stent.
See this image and copyright information in PMC

Comment in

References

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