A fully automated magnetically controlled capsule endoscopy (FAMCE) is similar to conventional transoral gastroscopy in completion of gastric examination and lesion detection, investigators reported in Lancet Gastroenterology and Hepatology.
The prospective, comparative study assessed the safety and efficacy of FAMCE in patients aged 18 to 80 years with suspected gastric pathology and no previous surgery. The participants had gastroscopy with FAMCE to screen for gastric lesions and then had conventional transoral gastroscopy 2 hours later. The primary outcome was the rate of complete detection of gastric anatomy landmarks with FAMCE.
Patients were enrolled between May 12, 2020, and August 17, 2020, at 2 centers in China. A total of 114 patients were included, 57 from each center. Participants’ median age was 44.0 (IQR, 34.0-55.0) years, and 63 (55%) were women.
The complete detection rate of 6 gastric anatomical structures by FAMCE (cardia, fundus, body, angulus, antrum, and pylorus) was 100% (95% CI, 99.3-100.0). The mean time of completion for FAMCE gastroscopy was 19.17 (SD, 1.43; median, 19.00; IQR, 19.00-20.00) minutes; the mean time for conventional transoral gastroscopy was 5.21 (SD, 2.00; median, 5.18; IQR, 3.68-6.45) minutes.
The concordance between FAMCE and conventional transoral gastroscopy for detecting 5 types of gastric lesions (gastritis, polyps, submucosal protuberances, mucosal erosion, and xanthoma) in multiple stomach segments was 99.61% (95% CI, 99.45-99.78; P <.0001).
A total of 214 lesions were detected by FAMCE and conventional transoral gastroscopy, of which 193 were detected by both methods. FAMCE missed 5 lesions, and conventional transoral gastroscopy missed 16. For gastritis detection, FAMCE detected 12 cases that were missed with conventional transoral gastroscopy, and conventional transoral gastroscopy detected 4 cases missed by FAMCE.
FAMCE for small bowel examination had a 100% completion rate and detected intestinal lesions in 50 (44%) patients, including enterocolitis (25%), small bowel lymphangiectasia (9%), and small bowel ulcers (7%).
A total of 2 patients had an adverse event: 1 with an upper respiratory tract infection and 1 with dysbiosis. No serious adverse events were reported.
Among several study limitations, the sample size was small and was from a well-defined geographical area in western China. Additionally, gastric and small bowel pathologies were limited in number and were not representative of the full range of upper gastrointestinal tract pathology, such as gastric ulcers or cancers.
“FAMCE has the potential to allow reallocation of medical or endoscopy staff and move care closer to a patient’s home, empowering primary care physicians worldwide to provide a more accurate referral pathway and earlier access to imaging techniques, which remain the only adequate base for care escalation,” the researchers concluded.
Xiao YF, Wu ZX, He S, et al. Fully automated magnetically controlled capsule endoscopy for examination of the stomach and small bowel: a prospective, feasibility, two-centre study. Lancet Gastroenterol Hepatol. Published online September 20, 2021. doi: 10.1016/S2468-1253(21)00274-0