Publication details
3D-Printed vs Commercial Distal Caps for ESD: Multicenter Randomized Ex Vivo Noninferiority Trial (ENDOPRINT Trial)
| Authors | |
|---|---|
| Year of publication | 2026 |
| Type | Peer-reviewed scientific article |
| Magazine / Source | Clinical and Translational Gastroenterology |
| MU Faculty or unit | |
| Citation | |
| web | https://journals.lww.com/ctg/fulltext/9900/3d_printed_vs_commercial_distal_caps_for_esd_.560.aspx |
| Doi | https://doi.org/10.14309/ctg.0000000000001022 |
| Description | INTRODUCTION: Distal attachment caps enhance visualization and traction during endoscopic submucosal dissection (ESD) but may influence procedural ergonomics. We conducted the multicenter ENDOPRINT randomized comparative feasibility study with a prespecified noninferiority hypothesis to compare a custom 3D-printed cap made from flexible medical-grade resin with a standard commercial cap using an ex vivo porcine model across tertiary centers in Prague, Olomouc, and Boston. METHODS: Across 3 centers, 99 ex vivo ESD procedures (33 per site) were randomized 1:1 to a 3D-printed cap or a commercial Olympus cap. The primary end point was procedure time; secondary end points included lesion size, en bloc resection, technical success, ergonomic parameters (visibility, scope manipulation, tissue retraction), cap handling, and adverse events. Group allocation was balanced across sites. RESULTS: Median procedure time was identical for both caps (17.3 minutes each; P = 0.952), remaining well within the predefined 20% noninferiority margin, and lesion sizes were comparable between groups. En bloc resection and technical success were achieved in 100% of cases in both arms. Ergonomic assessments favored the 3D-printed cap, with higher operator ratings for visibility, manipulation, and tissue retraction, all with P < 0.001 and consistent across all centers. Adverse events were uncommon and similar between groups. Procedure time correlated with lesion size (P = 0.001). DISCUSSION: The ENDOPRINT trial demonstrated that a 3D-printed distal cap is as efficient and safe as a commercial cap during ESD, while providing superior visibility, scope control, and tissue traction. These results support the potential of customizable 3D-printed accessories with substantially lower per-unit material costs compared with commercial devices for clinical practice and training, warranting further in vivo validation and formal cost-effectiveness studies. |