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3D-Printed vs Commercial Distal Caps for ESD: Multicenter Randomized Ex Vivo Noninferiority Trial (ENDOPRINT Trial)
Kral Jan1,2, Daryl Ramai3,4, Jakub Svet1
1Department of Internal Medicine, Motol University Hospital and Homolka, Second Faculty of Medicine, Charles University, Prague, Czech Republic.
Clinical and Translational Gastroenterology
|March 23, 2026
Summary
A new 3D-printed endoscopic submucosal dissection (ESD) cap matches commercial cap efficiency and safety. This 3D-printed cap offers improved ergonomics, including better visibility and tissue retraction, at a lower cost.
Area of Science:
- Gastroenterology
- Surgical Technology
- Biomedical Engineering
Background:
- Distal attachment caps aid visualization and traction in endoscopic submucosal dissection (ESD).
- Potential ergonomic impacts of these caps necessitate comparative studies.
- The ENDOPRINT study evaluated a novel 3D-printed cap against a commercial standard.
Purpose of the Study:
- To compare the feasibility and ergonomics of a custom 3D-printed ESD cap versus a standard commercial cap.
- To assess procedural efficiency, safety, and ergonomic parameters in an ex vivo porcine model.
Main Methods:
- A multicenter, randomized comparative feasibility study (ENDOPRINT) was conducted.
- 99 ex vivo ESD procedures were randomized between a 3D-printed cap and a commercial Olympus cap.
- Key endpoints included procedure time, lesion size, en-bloc resection, technical success, and ergonomic assessments.
Main Results:
- Procedure times were identical (median 17.3 minutes) for both caps, meeting non-inferiority criteria.
- 100% en-bloc resection and technical success were achieved with both caps.
- The 3D-printed cap demonstrated superior ergonomic performance in visibility, scope manipulation, and tissue retraction (p<0.001).
Conclusions:
- The 3D-printed cap is a safe and efficient alternative to commercial caps for ESD.
- Customizable 3D-printed accessories offer potential for reduced costs and improved ergonomics.
- Further in vivo validation and cost-effectiveness studies are warranted for clinical adoption.
