In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.
The nc-MCE system added a remote control workstation and an audio-visual exchange system to
the original well-establish MCE system.Conventional protective measures could be adopted to
endoscopist. Although the endoscopist and the patient are in different rooms, the endoscopist
was able to see the patient and communicate with him or her through the audio-visual exchange
system all the time. In order to simplify the examination procedure, the data recorder was
putted on the examination bed. The patient lay down after swallowing the capsule under the
remote guidance of the endoscopist.And the endoscopist of MCE and nc-MCE was the same one
with experience of more than 1000 cases of MCCG operation.
The investigators recruited 40 patients who have related symptom and healthy people mainly
from outpatient clinic or hospital health examination center. After fully understanding the
procedure of nc-MCE, patients with informed consent were randomly divided into MCE group and
nc-MCE group(1:1) by using a stratified block randomization(block size four).
The basic characteristics of the enrolled patients were prospectively collected. The primary
endpoint was the maneuverability score evaluated by endoscopist. And the investigators choose
the gastric examination time,the comfort and acceptability of patients, diagnostic yield and
completeness of gastric examination as the secondary endpoint. The safety endpoint of nc-MCE
was evaluated by the occurrence of adverse events.
Device: non-contact magnetically-controlled capsule endoscopy
The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.
Inclusion Criteria:
Signed the informed consents before joining this study
Exclusion Criteria:
(1) dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal
stenosis,overt gastrointestinal bleeding,fistulas and strictures; (2)history of upper
gastrointestinal surgery or suspected delayed gastric emptying; (3) Patients with poor
general condition,asthma or claus trophobia; (4) Implanted metallic devices such as
pacemakers,defibrillators, artificial heart valves or joint prostheses; (5) Pregnancy or
mentally ill person; (6) currently participating in another clinical study;(7)communication
obstacles persons.
Changhai Hospital
Shanghai, Shanghai, China
Zhuan Liao, MD, Study Chair
Department of Gastroenterology, Changhai Hospital, the Naval Medical University