RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large
Salmaan Jawaid1, Mai Khalaf2, Fares Ayoub2
1Division of Gastroenterology, Hepatology and Nutrition, Baylor College of Medicine, Houston, TX, USA. Salmaan.jawaid@bcm.edu.
Introduction:
Closure techniques for large endoscopic resection defects (ERD) have shifted from one step tissue apposition to tissue approximation first followed by complete closure. We compared the clinical efficacy and cost of two novel through-the-scope (TTS) tissue approximation devices in the management of large ERD.
Methods:
Single-center, prospective, randomized trial of ERD greater than 20 mm (width) or 30 mm (length). Approximation was performed via the dual-action tissue clip (DAT) or the TTS tack/suture device (TSD). The primary outcome was tissue approximation cost. The additional cost per successful tissue approximation (Incremental Cost-Effective Ratio) was calculated to determine cost-effectiveness.
Results:
The mean resection bed length (41.1 mm vs 40.7, p = 0.89) and width (23.8 mm vs 25.3 mm, p = 0.37) were similar in the TSD (n = 42) and DAT (n = 41) groups, respectively. Cost of tissue approximation ($946.60 vs $680.00, p = 0.001, 95% CI 120.8, 414.88, effect size d = 0.83) and complete closure ($2.10/mm2 vs $1.62/mm2, p = 0.04,95% CI 96.0, 601.3, d = 0.51) was higher in the TSD group. Technical success in tissue approximation (85.7% vs 90.2%, p = 0.56) and complete closure (97.6% vs 95.1%, p = 0.55) were similar in both TSD and DAT groups. However, TSD appeared to be more effective within the duodenum and when the resection bed was > 50% of the circumference. The ICER was-$6650.00 favoring the DAT clip. Approximation time (12.4 min vs. 4.2, p < 0.001, 95% CI 5.9, 10.6, d = 1.66) and closure speed (50.4 mm2/min vs 105.1 mm2/min, p < 0.001, 95% CI 30.9, 78.4, d = 1.08) were faster in the DAT arm. One clinically significant bleeding occurred in one subject in both groups.
Conclusion:
In this RCT, both TTS approximation devices equally facilitated approximation/closure of large ERD. Approximation with the DAT clip was faster and overall more cost-effective, but further studies are needed to determine the most appropriate approximation device based on location. The trial was registered in ClinicalTrials.gov under this identifier: NCT05163665.
