Published online May 16, 2019. doi: 10.4253/wjge.v11.i5.365
Peer-review started: March 8, 2019
First decision: April 13, 2019
Revised: April 30, 2019
Accepted: May 10, 2019
Article in press: May 11, 2019
Published online: May 16, 2019
Fully covered self-expandable metal stents (FCSEMSs) have been widely used as an effective biliary endoprosthesis in the setting of pancreaticobiliary conditions such as benign and malignant strictures, post-sphincterotomy bleeding, and occasionally bile leaks. The primary advantages of covered stents are a lower rate of tumor ingrowth, longer patency, and their potential removability compared to uncovered stents. However, one concern about FCSEMSs is a higher migration rate than uncovered stents. In this study, we conducted a retrospective analysis to evaluate the efficacy of 7-French (Fr) and 10-Fr double-pigtail plastic stent (DPS) within the FCSEMS as an anti-migration technique. We compared the rate of stent migration between patients who received FCSEMS alone and those who received both an FCSEMS and anchoring DPS in a large patient population with both benign and malignant strictures as well as non-stricture etiologies. We did not find evidence to support the routine placement of anchoring DPS. We found that anchoring of FCSEMS with a 7-Fr or 10-Fr DPS does not decrease the risk of stent migration.
FCSEMSs have been commonly used as an effective biliary endoprosthesis in the setting of pancreaticobiliary conditions such as benign and malignant strictures. To minimize the risk of migration, FCSEMSs have been designed with different anti-migration mechanical properties. The use of DPS is still unclear as an anti-migration method. Prospective randomized controlled studies are needed to evaluate the efficacy of an anchoring DPS within an FCSEMS as an anti-migration technique.
The main objective of the study was to assess to the rate of stent migration between patients who received FCSEMS alone and those who received both an FCSEMS and anchoring DPS in both benign and malignant strictures as well as non-stricture etiologies. To our knowledge, there are only two small retrospective studies that have evaluated the efficacy of anchoring DPS to prevent migration of FCSEMS. So, more randomized controlled trials with a larger number of patients are needed.
A retrospective analysis of endoscopy reporting system and medical records of patients who underwent ERCP with FCSEMS placement was conducted. The review and analysis were conducted through our endoscopy reporting system (ProVation® MD) and medical records. Patients included in the study had FCSEMS insertion for the treatment of malignant biliary stricture, benign biliary stricture, and non-stricture etiology such as post-sphincterotomy bleeding and bile leak. Data included stent type [WallflexTM (Boston Scientific) vs Viabil® (Gore Medical)], the diameter of double-pigtail PS (7-Fr vs 10-Fr), and indications for FCSEMS placement. We defined FCSEMS migration endoscopically if the stent was no longer visible through the major papilla. It either migrates proximally (into the bile duct) or distally (out of the bile of duct).
There was no significant association between any of the other tested variables including anchoring the FCSEMSs with DPS and the risk of stent migration. The migration rate in patients with anchored FCSEMSs with DPS was 6%, and those without anchoring DPS was 10% (P = 0.35). Overall, migration was reported in 18 patients with FCSEMS placement out of 203 patients with an overall migration rate of 9.7%. The distribution of patients that had a benign biliary stricture and previous sphincterotomy were significantly different between patients with stent migration and patients with no stent migration.
In our study, the risk of migration of biliary FCSEMS was 9.7 %. Anchoring an FCSEMS with a 7-Fr or 10-Fr DPS does not decrease the risk of stent migration. Routine placement of anchoring stents is unnecessary. We believe that further randomized controlled trials with a larger number of patients might be helpful to ascertain if anchoring an FCSEMS with DPS is useful as an anti-migration technique.
Anchoring of FCSEMS with a 7-Fr or 10-Fr DPS does not decrease the risk of stent migration. Only benign biliary stricture and previous Sphincterotomy were to have a significant association with stent migrations. Needs more prospective large studies. More randomized controlled trials with a larger number of patients are needed.