Retrospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. May 16, 2019; 11(5): 365-372
Published online May 16, 2019. doi: 10.4253/wjge.v11.i5.365
Should a fully covered self-expandable biliary metal stent be anchored with a double-pigtail plastic stent? A retrospective study
Saad Emhmed Ali, Wesam M Frandah, Leon Su, Cory Fielding, Houssam Mardini
Saad Emhmed Ali, Department of Internal Medicine, Division of Hospital Medicine, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
Wesam M Frandah, Cory Fielding, Houssam Mardini, Department of Internal Medicine, Division of Gastroenterology, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
Leon Su, Department of Statistics, College of Arts and Sciences, College of Public Health, University of Kentucky, Lexington, KY 40536, United States
Author contributions: Saad Emhmed Ali, Mardini H, Frandah WM and Cory Fielding C made the study design, data collection, and script preparation. Su L and Mardini H made the data analysis. Emhmed Ali SM, Frandah WM and Mardini H wrote the manuscript. Mardini H and Frandah WM was the reviewers of the paper.
Institutional review board statement: This study was approved by the Ethics Committee of the University of Kentucky Medical Center, No: 17-0287-X6B.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Saad Emhmed Ali, MD, Assistant Professor, Internal Medicine Physician, Department of Internal Medicine, Division of Hospital Medicine, Department of Internal Medicine, University of Kentucky, 800 Rose St, Lexington, KY 40536, United States. saad.ali@uky.edu
Telephone: +1-859-2184991 Fax: +1-859-2283352
Received: March 6, 2019
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
Processing time: 72 Days and 21.6 Hours
ARTICLE HIGHLIGHTS
Research background

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.

Research motivation

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.

Research objectives

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.

Research methods

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).

Research results

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.

Research conclusions

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.

Research perspectives

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.