Objective Currently available methods for small bowel endoscopy are often time consuming; motorised PowerSpiral Enteroscopy (PSE) is a further development of spiral enteroscopy to facilitate the approach to the small bowel. The aim of this bicentric prospective trial was to study feasibility and yield of peroral PSE.
Design Consecutive patients with suspected small bowel disease and indication for antegrade enteroscopy were included in two tertiary referral centres. Primary objective was diagnostic yield of antegrade PSE. Secondary objectives included technical success (defined as successful endoscope insertion at least to ligament of Treitz), depth of maximum insertion (DMI), median insertion time to DMI, rate of therapeutic procedures and adverse events.
Results During a 30-month period, 140 procedures were performed on 132 patients (58 female, 74 male; median age: 68 (20–100) years) under general anaesthesia. Overall diagnostic yield of PSE was 74.2%; with 68.2% of procedures including some form of endotherapy. Technical success rate of PSE was 97%; median DMI was 450 cm (0–600) with a median insertion time to DMI of 25 min (3–122). Antegrade panenteroscopy to the cecum was achieved in 14 cases (10.6%). Overall adverse event (AE) rate was 14.4%; two major serious AEs occurred (1.5%), one delayed perforation, one bleeding from Mallory-Weiss lesion.
Conclusion This pilot clinical trial demonstrates that PSE is effective for diagnostic and therapeutic antegrade enteroscopy and may compare favourably with traditional methods of deep enteroscopy in ease of use and procedural duration. More comparative data are required to assess clinical application and safety of PSE.
Trial registration number NCT02965209
- small bowel enteroscopy
- small bowel disease
- diagnostic and therapeutic endoscopy
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Contributors TB: participated in writing the study protocol, was responsible for conductance of the study at Evangelisches Krankenhaus Duesseldorf, coordinated the study centres, analysed the data and wrote the manuscript draft. HN: was the principle investigator of the study, wrote the study protocol, participated in analysing the data and writing the manuscript draft. JD: participated in writing the study protocol and the manuscript draft. All other authors: enrolled and treated patients at the study sites, critically reviewed the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Olympus Medical provided the endoscopic equipment and financial support for case documentation of the study. TB, MA, JD and HN received consultancy honorary and lecture fees from Olympus Medical Systems.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. Data are available on request from the authors.
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