Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution

Tom Magutu, Mercer University College of Pharmacy

Endoscopy is a widely used approach for the treatment of benign biliary strictures. [1]

Endoscopic retrograde cholangiopancreatography (ERCP) treatment of benign biliary strictures is considered to be significantly less morbid than surgical and percutaneous approaches and has reasonably low recurrence rates of biliary strictures when an aggressive treatment strategy is implemented. [2]

 

Title: Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution [3]
Design Randomized trial; N = 112
Objective To assess whether use of covered, self-expandable metallic stents (cSEMS) is noninferior to plastic stents with respect to stricture resolution
Study Groups Patients with treatment naive, benign biliary strictures due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4) were randomized to receive multiple plastic stents (n = 55) or a single cSEMS (n = 57).
Methods Multiple plastic stent group patients were treated per standard of care, follow up endoscopic retrograde cholangiopancreatography procedures (ERCP) were performed 3 to 4 months later and the stricture was assessed for resolution.  In the cSEMS group, the endoscopist deployed a cSEMS of sufficient length to traverse the stricture and the papilla. Follow-up ERCP was performed 6 months after the procedure.  When stricture resolution occurred per study criteria, all stents were removed and not replaced.
Duration April 2011 to October 2015
Primary Outcome Measure Stricture resolution rate
Baseline Characteristics Variable Multiple plastic stents cSEMS
Age, mean (SD), y 56.7 (11) 54.5 (10.4)
Women, no (%) 17 (30.9) 19 (33.3)
Stricture characteristics, median (range)    
Distance of top of stricture to the hepatic confluence, mm 34 (1-85) 36 (2.36-86)
Diameter of duct upstream of stricture, mm 11 (5.7-13.0) 10 (6-18)
Diameter of duct downstream  of stricture, mm 8 (5.0-8.5) 7 (0-13.7)
Stricture length, mm 5 (0.7-38) 4 (1-32)
Previous single plastic stent in place, No. (%) 16 (29.1) 23 (40.4)
Results   Rate of stricture resolution (%) at  n days
90 days 180 days 270 days 360 days p value
Multiple plastic stents group 9.09 40.0 67.2 89.1  

 

0.007

cSEMS group 19.29 52.6 89.4 94.7
Adverse Events Common Adverse Events
Adverse event Multiple plastic stent n (%) cSEMS n (%)
Stent migration 9 (16.4) 14 (24.6)
Premature stent occlusion 3 (5.5) 3 (5.3)
Stent induced changes to bile duct 5 (9.1) 3 (5.3)
Abdominal pain 8 (14.5) 8 (14)
Post ERCP pancreatitis 3 (5.5) 3 (5.3)
Serious Adverse events
Adverse events Multiple plastic stent n (%) cSEMS n (%)
Stent migration 1 (1.8) 2 (3.5)
Premature stent occlusion 1 (1.8) 3 (5.2)
Stent induced changes to bile duct 0 0
Abdominal pain 1 (1.8) 2 (3.5)
Post ERCP pancreatitis 0 0
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Among patients with benign biliary strictures of 6 mm or larger in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents in achieving stricture resolution after no more than 12 months of endoscopictherapy.  Metallic stents should be considered an appropriate option in such patients.

 

Self-expandable metallic stents addressed an unmet need for durable biliary drainage in the setting of malignant bile duct obstruction, a finding that is mirrored by the results of this study, which focused on benign biliary stricture.  The study shows that the use of cSEMS as initial treatment can achieve resolution of a benign biliary stricture.  The absence of a cost analysis comparing the two treatment strategies creates a need for future studies.

 

References

  1. Costamagna G, Boškoski I. Current treatment of benign biliary strictures. Ann Gastroenterol. 2013;26(1):37-40.
  2. Dumonceau JM, Delhaye M, Tringali A, et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2012;44(8):784-800.
  3. Coté GA, Slivka A, Tarnasky P, et al. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016;315(12):1250-7.
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