A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
Phase: NA
Conditions: Outpatients
Sponsor: Changhai Hospital

Detachable
Detachable
Detachable
Detachable string
string
string
string magnetically
magnetically
magnetically
magnetically controlled
controlled
controlled
controlled capsule
capsule
capsule
capsule endoscopy
endoscopy
endoscopy
endoscopy for
for
for
for completely
completely
completely
completely viewing
viewing
viewing
viewing
the
the
the
the esophagus
esophagus
esophagus
esophagus and
and
and
and stomach
stomach
stomach
stomach：study
study
study
study protocol
protocol
protocol
protocol for
for
for
for a self
self
self
self-controlled
controlled
controlled
controlled single-center
single-center
single-center
single-center study
study
study
study
Document
Document
Document
Document Date:
Date:
Date:
Date: March
March
March
March 1,
1,
1,
1, 2018
2018
2018
2018
Trial
Trial
Trial
Trial registration:
registration:
registration:
registration: ClinicalTrials.gov
ClinicalTrials.gov
ClinicalTrials.gov
ClinicalTrials.gov ID:
ID:
ID:
ID: NCT03457909
NCT03457909
NCT03457909
NCT03457909
Objective
Objective
Objective
Objective
Esophageal capsule endoscopy (ECE) was reported not accurate enough to replace EGD as the passive
passage of ECE through the esophagus precluded a thorough investigation. We developed a modified capsule
endoscopy, called detachable string magnetically controlled capsule endoscopy (DS-MCE) and performed a
pilot study to assess the feasibility and safety of DS-MCE.
Study
Study
Study
Study design
design
design
design
This study is a prospective, single-centered pilot study. The study protocol has been approved by the
institutional review board of Changhai Hospital (Second Military Medical University, Shanghai, China).
Study
Study
Study
Study patients
patients
patients
patients
Healthy volunteers and patients with suspected esophageal diseases will be prospectively enrolled in
Changhai Hospital from March 2018 to June 2018. Patients with any MCE contradictions will be excluded.
Study
Study
Study
Study intervention
intervention
intervention
intervention
After enrollment, each subject will first undergo DS-MCE, and subsequently EGD within one week. DS-MCE
will be performed by an endoscopist (W.Z.) with an experience of ＞500 cases of MCE operation. Another
endoscopist (W.B.Z.) who is blinded to the DS-MCE diagnosis will perform the EGD examinations and
interprete the images. EGD examination are carried out under topical pharyngeal anesthesia induced by a

single oral dose of 100 mg dyclonine hydrochloride.
Capsule
Capsule
Capsule
Capsule endoscopy
endoscopy
endoscopy
endoscopy devices
devices
devices
devices and
and
and
and procedure
procedure
procedure
procedure
Procedures are performed using the NaviCam magnetic capsule guidance system (Ankon Technologies,
Shanghai, China). The DS-MCE system consists of two parts, a thin and transparent latex sleeve with an 80cm
long hollow string attached to its cauda end and a sterile syringe for single use. The capsule partially enclosed
in the sleeve can be detached from the string system through injecting air into the hollow string with the syringe.
In a left lateral position, subjects swallow the capsule with water, without any sedation. The capsule is allowed
to travel down approximating the gastric cardia, from where the string is slowly pulled up to inspect the
esophagus under the guidance of real-time viewing. Images are captured at a rate of 2 frames per second.
Target areas of interest can be observed repeatedly. If bubbles obscure the view, subjects are instructed to sip
a little water until the esophageal image improved. After completing the esophagus examination, the string is
separated from the capsule through injecting 5 ml air with the syringe, taken out of the mouth and discarded,
while the capsule entered the stomach with additional water ingestion. Stomach examination and small bowel
examination (if needed) are carried out according to standardized protocol.
Study
Study
Study
Study outcomes
outcomes
outcomes
outcomes
Primary outcome is the success rate of DS-MCE, a composite outcome defined as the success rate of
completely viewing the esophagus (from the capsule being swallowed, the esophagus observed retrograde, to
the string being pulled out after separating from the capsule), detachment of string and capsule at the end of
esophageal examination and entering the stomach. Secondary outcomes include safety, discomfort associated
with the procedure, diagnostic accuracy, image quality and Z-line visualization. All patients will be followed up
to 2 weeks to confirm capsule excretion and any adverse events. Any discomfort during the procedure is
evaluated with the Ramirez system and our previous system, on a scale from 0 to 3 (0, no; 1, mild/minimal; 2,

moderate; and 3, severe/very difficult). Overall discomfort is scored on a scale of 0 to 10 (0, no discomfort; 10,
the overall discomfort of EGD). Also, subjects will be asked the preference of DS-MCE and EGD. The
diagnostic accuracy of DS-MCE is assessed by esophageal diagnosis and grade of reflux esophagitis and
esophageal varices in comparison to EGD. Reflux esophagitis and esophageal varices identified during EGD
and DS-MCE are classified using the Los Angeles classification, Baveno III consensus and DFC.
All the images obtained by DS-MCE are monitored in real time and capsule findings were documented by an
experienced endoscopist (X.L.). Another endoscopist (X.J.) independently graded Z-line viewing (the number
of quadrants captured on the Z-line), image quality and the air bubbles with our previous system. The bubble
grade ranges from 0 to 3 (0, no bubble; 1, a few bubbles; 2, increased amount of bubbles; 3, severe bubbles).
Image quality grade ranges from 1 to 10 (1, the worst quality; 10, the quality of the image captured by EGD).
Central
ntral
ntral
ntral contact
contact
contact
contact
Zhuan Liao
National Clinical Research Center for Digestive Diseases; Department of Gastroenterology, Changhai Hospital,
Second Military Medical University, 168 Changhai Road, Shanghai 200433, China
Tel: 86-21-31161004; Fax: 86-21-65492727
E-mail: liaozhuan@smmu.edu.cn