Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution

A randomized clinical trial

Gregory A. Coté, Adam Slivka, Paul Tarnasky, Daniel K. Mullady, B. Joseph Elmunzer, Grace Elta, Evan Fogel, Glen Lehman, Lee McHenry, Joseph Romagnuolo, Shyam Menon, Uzma D. Siddiqui, James Watkins, Sheryl Lynch, Cheryl Denski, Huiping Xu, Stuart Sherman

Research output: Contribution to journalArticle

62 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)1250-1257
Number of pages8
JournalJournal of the American Medical Association
Volume315
Issue number12
DOIs
StatePublished - Mar 22 2016

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Plastics
Stents
Pathologic Constriction
Randomized Controlled Trials
Cystic Duct
Endoscopic Retrograde Cholangiopancreatography
Chronic Pancreatitis
Self Expandable Metallic Stents
Bile Ducts
Gallbladder
Sample Size
Therapeutics
Referral and Consultation
Transplants
Recurrence
Liver
Wounds and Injuries

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution : A randomized clinical trial. / Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart.

In: Journal of the American Medical Association, Vol. 315, No. 12, 22.03.2016, p. 1250-1257.

Research output: Contribution to journalArticle

Coté, GA, Slivka, A, Tarnasky, P, Mullady, DK, Elmunzer, BJ, Elta, G, Fogel, E, Lehman, G, McHenry, L, Romagnuolo, J, Menon, S, Siddiqui, UD, Watkins, J, Lynch, S, Denski, C, Xu, H & Sherman, S 2016, 'Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution: A randomized clinical trial', Journal of the American Medical Association, vol. 315, no. 12, pp. 1250-1257. https://doi.org/10.1001/jama.2016.2619
Coté, Gregory A. ; Slivka, Adam ; Tarnasky, Paul ; Mullady, Daniel K. ; Elmunzer, B. Joseph ; Elta, Grace ; Fogel, Evan ; Lehman, Glen ; McHenry, Lee ; Romagnuolo, Joseph ; Menon, Shyam ; Siddiqui, Uzma D. ; Watkins, James ; Lynch, Sheryl ; Denski, Cheryl ; Xu, Huiping ; Sherman, Stuart. / Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution : A randomized clinical trial. In: Journal of the American Medical Association. 2016 ; Vol. 315, No. 12. pp. 1250-1257.
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T2 - A randomized clinical trial

AU - Coté, Gregory A.

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AU - Mullady, Daniel K.

AU - Elmunzer, B. Joseph

AU - Elta, Grace

AU - Fogel, Evan

AU - Lehman, Glen

AU - McHenry, Lee

AU - Romagnuolo, Joseph

AU - Menon, Shyam

AU - Siddiqui, Uzma D.

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N2 - 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

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