Randomized controlled trial to investigate the effect of metal clips on early migration during stent implantation for malignant esophageal stricture

Abstract

Background:The rate of stent migration, especially in the short term after implantation, is high in the treatment process. We sought to explore an effective method for preventing early migration after stent implantation for malignant esophageal stricture and to provide the basis for clinical treatment. Methods:We conducted a prospective, open-label, parallel-assignment randomized controlled trial with patients undergoing stent implantation for malignant esophageal stricture. The proximal segments of stents in the treatment group were fixed with 2 metal clips during the perioperative period of esophageal stent implantation, while no treatment was used in the control group. All patients underwent radiography at 3 and 7 days and 1 and 3 months after placement to assess the stent migration.Results: There were 83 patients in our study. Demographic characteristics were similar between the groups. There was no stent migration observed in the treatment group within 2 weeks of the operation, while stent migration was observed in 6 of 41 (14.6%) cases in the control group, occurring at 3 and 7 days after placement. There were no perioperative complications. Conclusion:Perioperative fixation of the proximal segments of stents with metal clips is effective in preventing early stent migration.Contexte : Le taux de migration des endoprothèses est élevé, surtout peu de temps après leur pose, au cours du processus thérapeutique. Nous avons voulu trouver une méthode efficace pour prévenir la migration précoce des endoprothèses peu après leur pose pour la sténose oesophagienne d'origine maligne et établir la base du traitement clinique.

A newly designed over-the-scope-clip device to prevent fully covered metal stents migration: A pilot study

“…In a randomized controlled trial, early stent migration did not occur in patients with malignant esophageal strictures when 2 TTS clips were symmetrically placed at the proximal end of the stent for fixation vs 14.6 of migration rate in the control group [6].…”

Predictive Factors for the Migration of Endoscopic Self-Expanding Metal Stents Placed in the Foregut

“…Analogous techniques have been used with stents as an attempt to reduce stent migration rates, including utilizing metal endoscopic clips to attach the stent to the mucosa and transnasal sutures that attach at the proximal end of the stent, run proximally and out through the nose and are attached to the patient externally. 16,17 Endoscopically suturing the stents to the mucosa was used in our cohort in addition to clips and transnasal suturing. Because of the small number of patients in our cohort with fixation, it is not surprising that we were unable to discern a significant difference in migration rate.…”

“…Two studies involving porcine models found that endoscopic sutures increased the force necessary to dislodge inserted SEMS, 19,20 while another 2 showed a reduction due to fixation in the clinical setting. 21,22 Furthermore, a recent randomized controlled study by Wang et al 16 found that stent fixation with metal clips is effective in preventing stent migration. While our study could not detect a benefit of utilizing fixation to prevent migration, there still may be a place for stent fixation and further prospective analysis with larger power is warranted.…”

“…[9][10][11][12][13] Stent migration rates range from 3.7% to 50% depending on the stent's diameter, the covering, location of insertion, and material used to make the stent. [14][15][16][17] Migration has been associated with significant morbidity and complications, including failure to resolve the leak or stricture and the need for subsequent procedures, such as surgical removal of the stent and repeat endoscopy for stent replacement. 18 We reviewed our experience with using SEMS to manage GI disorders in the foregut and compared our results with recently published studies.…”

Endoscopic removal of migrated esophageal stent: the “cap-assisted” method

“…1 e). Esophageal stent migration is a common complication with an incidence of 14.6 % [1]. Distal migration of the stent can lead to complications such as intestinal obstruction and impaction [2,3].…”