A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) versus Standard Uncovered Stents (Placed Endoscopically)

Abstract

The aim of our study is to compare the efficacy and safety of “outlet-shape” tailored stents with standard stents for the management of distal gastric cancer causing gastric outlet obstructions (GOOs) with varying gastric cavity shapes and sizes. To determine the shape and size of the GOOs, stomach opacifications were performed using contrast media before stenting. Two basic shapes of the residual cavity of the proximal GOO were observed: cup shaped or approximately cup shaped and funnel shaped or approximately funnel shaped. Other shapes were not found. In the GOO tailored group, the size and shape of the proximal ends of the tailored stent were suited for the residual cavity of the proximal GOO. The tailored stents included large cup-shaped stents and large funnel-shaped stents. GOO tailored covered stents led to less restenosis and reintervention rates compared to standard uncovered stents but with the same survival.

Stents and surgical interventions in the palliation of gastric outlet obstruction: a systematic review

“…In this analysis, high heterogeneity was found (I 2 : 87 %), with one outlier study 16. After excluding this trial, there is no significant difference between the stents (RD: – 0.08, 95 % CI: [-0.17, 0.00], I 2 : 6 %) (Fig.…”

“…A subgroup analysis of trials with SEMS, which included only gastric cancer patients, was performed 15 16 31. Results of this analysis are very similar to the global analysis ( Appendix 2 ).…”

“…The most recent and complete were included for meta-analysis. Finally, 5 clinical randomized trials were selected for covered and uncovered SEMS, including 443 patients 15 16 17 30 31. Three studies were considered for comparison between surgery and stents, with a total of 84 patients 12 26 27.…”

“…An outlier study was detected and removed 16, resulting in low heterogeneity and no difference between groups (RD: – 0.01, 95 % CI: [-0.03, 0.02], I 2 : 0 %) (Fig. 10).…”

“…With the development of new technologies and new randomized trials, we expect changes in the management of gastric outlet obstruction, a fact that demands analysis of which kind of therapy is better and if there is a difference between covered and uncovered stents 15 16 17. The published systematic reviews with meta-analyses about this subject does not include those new randomized clinical trials and considered analysis with non-randomized trials together 18 19 20 21 22 23 24.…”