Novel Endoscopy System Feasible for Evaluation of Upper GI Diseases

A novel cable-transmission magnetically controlled capsule endoscope (CT-MCCE) system was feasible and safe in examining upper gastrointestinal diseases, according to late-breaking data presented at Digestive Disease Week (DDW) 2024.

The prospective, multicenter, self-controlled clinical trial found CT-MCCE performed comparably with conventional gastroscopy among eligible patients with upper gastrointestinal diseases between October 2022 and May 2023.

“The results of this study demonstrate that CT-MCCE performs comparably to EGD in completing upper GI tract examinations and detecting lesions,” wrote the investigative team, led by Yuan Tian, MD, Peking University First Hospital. “Additionally, the enhanced tolerance of CT-MCCE in identifying upper GI diseases was highlighted without any reported adverse events.”

Gastrointestinal diseases and pre-cancerous lesions often present as asymptomatic, making screening and diagnosis important for treatment outcomes. Gastroscopy is considered the ‘gold standard’ in diagnosing gastric lesions but can prove unfeasible for screening due to its invasive nature and low compliance rates.

MCCE was introduced as a non-invasive, efficient diagnostic tool to overcome the limitations of conventional endoscopy and use external magnetic control for safe and accurate gastric evaluation. However, there are limited data on its use for screening gastrointestinal lesions in asymptomatic individuals and the image quality can be poor.

In this study, Tian and colleagues investigated a new CT-MCCE system to evaluate its safety and feasibility and safety through a clinical trial evaluation. All eligible participants aged 18 - 75 years underwent screening for upper GI diseases using the novel CT-MCCE and then underwent esophagogastroduodenoscopy (EGD) without sedation after a 2-hour period.

The primary study endpoints assessed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for detecting focal lesions within the esophagus, stomach, and duodenal bulb using CT-MCCE. Convention gastroscopy served as the standard for analysis.

This analysis was performed for the full analysis set and the per-protocol set. Adverse events associated with CT-MCCE and conventional gastroscopy were systematically assessed in the analysis. Overall, 180 individuals (mean age, 43.1 years; 52% female) were enrolled from 3 hospitals in China.

Accuracy was evaluated using 180 individuals in the full analysis set and 179 individuals in the per-protocol set. After performing the per-protocol set analysis, CT-MCCE demonstrated high sensitivity in detecting esophageal lesions at 97.22%, specificity at 100%, a PPV of 100%, an NPV of 98.17%, and an accuracy of 98.88%.

In the examination of the full analysis set, CT-MCCE also demonstrated high sensitivity and specificity for detecting upper gastrointestinal lesions. The CT-MCCE was successful in identifying 1 advanced gastric carcinoma, 1 esophageal cancer, and 2 early-stage esophageal tumors without mission significant lesions, such as tumors or large ulcers.

Notably, the CT-MCCE exhibited a lower discomfort incidence compared with esophagogastroduodenoscopy (P <.001). Tian and colleagues noted no adverse events were identified in any of the populations during the study period, suggesting the enhanced tolerance of CT-MCCE in identifying upper GI diseases.

“Therefore, this innovative CT-MCCE system may be regarded as an effective diagnostic tool for upper GI tract evaluation,” they wrote.

References

1. _{Tian Y, Du S, Liu H, Bai R, Su H, Rong L. Prospective, Multicenter, Self-Controlled Clinical Trial on the Effectiveness and Safety of a Novel Cable-Transmission Magnetically Controlled Capsule Endoscope System for the Examination of Upper Gastrointestinal Distress. Lecture presented at Digestive Disease Week 2024, May 18 - 21, 2024.}
2. _{Li J, Ren M, Yang J, et al. Screening value for gastrointestinal lesions of magnetic-controlled capsule endoscopy in asymptomatic individuals. J Gastroenterol Hepatol. 2021;36(5):1267-1275. doi:10.1111/jgh.15282}