麻豆传媒

A fully automated magnetically controlled capsule endoscopy (FAMCE) was found to be comparable to conventional transoral gastroscopy for gastric examination and lesion detection in a prospective feasibility study conducted at two centers in China.

FAMCE was used to image the stomach and small bowel of 114 patients and detected 100% of gastric anatomical structures (95% CI 99.3-100%), reported Xia Xie, MD, of Second Affiliated Hospital of the Third Military Medical University in Chongqing, and colleagues.

As shown in their study in , the number of missed lesions was five (four cases of gastritis and one polyp) with FAMCE, compared with 16 (12 cases of gastritis, one polyp, one fundal xanthoma, and two antral erosions) with conventional gastroscopy. Furthermore, there was no evidence of capsule retention or serious adverse events associated with FAMCE, the researchers said.

"Therefore, FAMCE is an effective method that can be used in the examination of the gastrointestinal tract," the team wrote.

Xie and co-authors explained that while conventional gastroscopy remains the gold standard for detecting gastric pathologies, some patients may not be able to tolerate the cardiovascular stress associated with the procedure. FAMCE is less invasive, with a magnet used to control the position of a video capsule swallowed by the patient.

Hand-held and robot-assisted magnetically controlled endoscopy techniques have been used for gastric exams, but each have their downsides, the investigators continued. For example, the need for skilled operators for hand-held procedures, and the size and cost of robotic devices, as well as the reliance on an operator to control capsule endoscopy movement.

FAMCE, on the other hand, can complete the entire gastric examination automatically, without an operator on the robotic arm capsule controller, and has the added advantage of being able to complete an examination of both the small bowel and stomach in a single sitting due to the capsule's extended battery life, Xie and colleagues noted.

Writing in an , Jean-Francois Rey, MD, of Institut Arnault Tzanck in Saint-Laurent-du-Var, France, said: "This non-invasive technique would be a major advantage in daily clinical practice."

"The use of robotic control and full automation opens a new era for capsule endoscopy," he continued, adding that since no human operator is needed with FAMCE, it should also minimize the risk of human error.

Next steps should be large multicenter trials to encourage the use of the technology beyond China, Rey suggested. "Given that the technique is already well developed in China and shows promising results, it should be evaluated elsewhere urgently."

Xie and co-authors called FAMCE "an additional versatile and automated tool in the field of robotic gastroscopy."

The technique 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 wrote.

Study Details

The prospective comparative study was conducted at two university hospitals in Chongqing. Patients were ages 18 to 80, and had suspected gastric pathology with no previous surgery.

Participants underwent gastroscopy with FAMCE followed by conventional transoral gastroscopy 2 hours later, with the results compared by two different expert groups.

The primary outcome was the rate of complete detection of gastric anatomy structures, including the cardia, fundus, body, angulus, antrum, and pylorus. Secondary outcomes were the time required for exam completion, the rate of detection of gastric lesions compared with conventional transoral gastroscopy, and the rate of complete small bowel examination.

The mean completion time of gastroscopy with FAMCE was 19.17 minutes (SD 1.43, median 19.00, IQR 19.00-20.00), compared with 5.21 minutes (SD 2.00, median 5.18, IQR 3.68-6.45) for conventional transoral gastroscopy.

Overall, 214 lesions were detected by FAMCE and conventional gastroscopy, and 193 were detected by both modalities. FAMCE found one fundal xanthoma and two antral erosions, which were undetected with conventional gastroscopy.

FAMCE also was able to complete a small bowel examination in every patient, and detected intestinal lesions in 44%.

Two patients undergoing FAMCE had adverse events -- one upper respiratory tract infection and one case of dysbiosis – both of which were unrelated to FAMCE, the researchers said.

Study limitations, the team said, included the small number of patients enrolled and that they were all from a well-defined geographical area in western China; and that the gastric and small bowel pathologies identified (as is often the case with feasibility trials) were limited in number and thus cannot be considered representative of the full spectrum of upper gastrointestinal tract pathology.

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