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A RANDOMIZED CONTROL TRIAL COMPARING THE MIGRATION RATE AND COST-EFFECTIVENESS OF FULLY COVERED ESOPHAGEAL STENTS WITH AND WITHOUT ENDOSCOPIC SUTURE FIXATION
Date
May 21, 2024
Background
High migration rates have been reported for fully covered esophageal stents. Endoscopic suture fixation may prevent migration and be cost-effective; however, prospective studies are lacking. Therefore, we performed a randomized controlled trial (RCT) comparing migration rates and other adverse events after placement of esophageal stents with and without suture fixation. Economic evaluations were also carried out to assess the cost-effectiveness of suture fixation of stents.
Methods
We performed an RCT involving adult patients with severe esophageal strictures undergoing covered esophageal stent placement at our institution (ClinicalTrials.gov Identifier: NCT05082948). Patients were randomly assigned (1:1 stratified randomization based on benign or malignant etiology of strictures) to stent placement with endoscopic suture fixation (fixation group) and stent placement alone (non-fixation group). Two running sutures were placed in the fixation group using the over-the-scope endoscopic suturing device (Overstitch System; Apollo Endosurgery, Austin, TX) (Video). The primary study outcome was stent migration (stent displacement > 20 mm from baseline position) assessed with a chest radiograph by a study radiologist and/or endoscopic visualization at 4 weeks after placement. Clinically significant migrations were also noted, and cost-effectiveness was assessed through an incremental cost-effectiveness ratio (ICER) and cost per migration averted.
Findings
Between July 2021 and December 2022, 46 patients were enrolled – 24 in the fixation group and 22 in the non-fixation group. A comparison of baseline and procedure-related characteristics in the two groups is presented in Table 1. In intention-to-treat analysis, the stent migration rate was significantly lower in the fixation group compared to the non-fixation group (Risk ratio, 0.28, 95% CI, 0.11-0.74, p = 0.008). Other outcomes, including other adverse events, were similar in both groups, except procedure duration, which was higher in the fixation group (p = 0.001) (Table 2). Cost-effectiveness analysis showed that stent placement with endoscopic suturing was cost-effective, with $28,856 per migration averted with endoscopic suturing, compared to $6,495 per migration averted with no fixation. The trial was terminated after an interim analysis clearly showed inferior primary outcomes in the non-fixation group.
Interpretation
Endoscopic suture fixation of fully covered esophageal stents was associated with a decreased migration risk without an increased risk of other adverse events. Moreover, suture fixation was cost-effective compared to no fixation. A high migration rate of non-fixed covered esophageal stents was noted; therefore, fixation of these stents should be considered. Further prospective studies are needed to compare endoscopic suturing and other modalities for stent fixation.
High migration rates have been reported for fully covered esophageal stents. Endoscopic suture fixation may prevent migration and be cost-effective; however, prospective studies are lacking. Therefore, we performed a randomized controlled trial (RCT) comparing migration rates and other adverse events after placement of esophageal stents with and without suture fixation. Economic evaluations were also carried out to assess the cost-effectiveness of suture fixation of stents.
Methods
We performed an RCT involving adult patients with severe esophageal strictures undergoing covered esophageal stent placement at our institution (ClinicalTrials.gov Identifier: NCT05082948). Patients were randomly assigned (1:1 stratified randomization based on benign or malignant etiology of strictures) to stent placement with endoscopic suture fixation (fixation group) and stent placement alone (non-fixation group). Two running sutures were placed in the fixation group using the over-the-scope endoscopic suturing device (Overstitch System; Apollo Endosurgery, Austin, TX) (Video). The primary study outcome was stent migration (stent displacement > 20 mm from baseline position) assessed with a chest radiograph by a study radiologist and/or endoscopic visualization at 4 weeks after placement. Clinically significant migrations were also noted, and cost-effectiveness was assessed through an incremental cost-effectiveness ratio (ICER) and cost per migration averted.
Findings
Between July 2021 and December 2022, 46 patients were enrolled – 24 in the fixation group and 22 in the non-fixation group. A comparison of baseline and procedure-related characteristics in the two groups is presented in Table 1. In intention-to-treat analysis, the stent migration rate was significantly lower in the fixation group compared to the non-fixation group (Risk ratio, 0.28, 95% CI, 0.11-0.74, p = 0.008). Other outcomes, including other adverse events, were similar in both groups, except procedure duration, which was higher in the fixation group (p = 0.001) (Table 2). Cost-effectiveness analysis showed that stent placement with endoscopic suturing was cost-effective, with $28,856 per migration averted with endoscopic suturing, compared to $6,495 per migration averted with no fixation. The trial was terminated after an interim analysis clearly showed inferior primary outcomes in the non-fixation group.
Interpretation
Endoscopic suture fixation of fully covered esophageal stents was associated with a decreased migration risk without an increased risk of other adverse events. Moreover, suture fixation was cost-effective compared to no fixation. A high migration rate of non-fixed covered esophageal stents was noted; therefore, fixation of these stents should be considered. Further prospective studies are needed to compare endoscopic suturing and other modalities for stent fixation.
Table 1: Baseline Characteristics of patients.
Table 2: Outcomes in the fixation and non-fixation esophageal stent groups.
Presenter
West Virginia University
Tracks
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