Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient
Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient
Newly development of capsule endoscopy provides a comfortable and minimal invasive modality
 which is an alternative to conventional esophagogastroduodenoscopy(EGD). The use of capsule
 endoscopy beyond the small bowel is increasing and several capsule endoscopy systems have
 been introduced for the examination of the esophagus and colon. The current capsule endoscopy
 systems are less effective for the upper gastrointestinal tract examination. Short transit
 time in the esophagus and the passive movement of the capsule makes it more difficult to
 identify or visualize the lesion comparing with traditional EGD. The sensitivity rate of
 esophageal varices detection from capsule endoscopy was ranging from 65% to 80%. In order to
 control the capsule in the gastrointestinal tract for better visualization, many methods are
 invented. Magnetically assisted capsule endoscopy systems and string-mounted capsule
 endoscopy are applied in many studies. Magnetically assisted capsule endoscopy system and
 string-mounted capsule endoscopy are used to control the capsule endoscopy for elongating
 esophagus transit time to have a better visualization of the esophagus. The InsightEyes EGD
 System combines the string and magnetic assisted capsule endoscopy system to provide a
 real-time high-quality image during the examination. On the other hand, 3D image processing
 can be used for distinguishing the esophageal varices and normal folds well, theoretically.
 Thus, in this study, the investigators combine string, magnetically assisted capsule
 endoscopy systems, and 3D image processing together to form a new system for improving the
 detection of esophageal varices and other gastric lesions.
This is a prospective and observational study. Sample size calculation and patient selection
 The investigators plan to include a total of 140 participants in this study. Sixty-five
 cirrhotics with portal hypertensive symptoms (such as platelets count less than 100,000) will
 be enrolled to evaluate for the presence and stage of esophageal varices by using a
 magnetic-assisted capsule endoscope system. Thirty-five cirrhotics patients with history of
 endoscopy-confirmed esophageal varices will be included for the follow-up examination by
 using the magnetic-assisted capsule endoscope system. Another 40 healthy volunteers without
 known gastrointestinal disease will be enrolled as the control group. Those participants with
 less than 20-year-old, having implanted electronic or magnetic devices, pregnant, or unable
 to swallow the capsule, will be excluded from the study.

 Intervention The patient will undergo both diagnostic tests in two days, with a
 magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on
 at least 4 hours afterward.

 Magnetic-assisted capsule endoscope system (MACE, InsightEyes EGD System) with or without 3D
 images("MedicalTek" Endoscopic Imaging system and accessories) will be used for detecting
 esophageal varices and other possible lesions. As standard per-endoscopy preparation,
 patients undergo a 6-8 hour fast. The participants take 400 mg of N-acetylcysteine solution
 in 200 mL of water 1 h before the MACE examination and an additional 300 mL of clear water
 after 30 min to remove gastric mucus. With the upright(sitting) position, the patient is
 instructed to swallow the capsule with 20mL of clear water. The hand-held magnet is held
 above the sternum in order to catch the capsule and examine the esophagus. Capsule endoscopy
 is manipulated by changes in the patient's position and hand-held magnet. The magnetic field
 navigator is placed in front of the patient's abdomen and helped the capsule moving and
 rotating by moving the magnetic field navigator.

 The capsule endoscopy will end up in the second portion of the duodenum as the conventional
 EGD does.

 The lesion is detected using 2D and 3D imaging at the same time during the examination.

 Esophagogastroduodenoscopy (EGD) EGDs (Olympus GIF-H290) are conducted by experienced
 endoscopists. These practitioners are able to check the indication of the procedure and
 previous findings of EGD. The EGDs are conducted by standard techniques. The patient
 undergoes pharyngeal anesthesia and then EGD.

 Preparation evaluation The quality of gastric preparation includes the degree of mucosal
 visibility and stomach distention. The degree of mucosal visibility is classified into four
 grades: excellent = no adherent mucus on the gastric mucosa; good = small amount of mucus on
 the gastric mucosa but without obscured vision; fair = small amount of mucus on the gastric
 mucosa with partially obscured vision; and poor = profuse mucus on the gastric mucosa with
 obscured vision.

 Stomach distention is classified into three grades: good = satisfactory stomach distention
 with the remaining small amount of collapsed gastric folds; fair = considerable amount of
 collapsed gastric folds that obscure some parts of the stomach; and poor = insufficient
 stomach inflation, and examination of the area of interest is impossible. The investigators
 evaluate the proximal (cardia, fundus, and upper body) and distal (lower body and antrum)
 portions of the stomach separately.

 Lesion detection Esophageal varices detection Esophageal varices will be evaluated and
 described according to the Japanese Research Society for Portal Hypertension.

 Other lesion detection Another lesion is evaluated including portal hypertensive gastropathy,
 peptic ulcers, and polyps.

 Questionnaire on comfort and acceptance After the examinations, the patient will receive a
 questionnaire, including the pain during the examination by using a visual analog scale
 (VAS), scoring from 1(no pain) to 10(badly painful, barely tolerable), other discomforts such
 as nausea and abdominal fullness. The questionnaire also includes the preferred choice of two
 modalities.

 Study outcomes Primary outcome

 1. The investigators will compare the detection rate of esophageal varices in the cirrhotic
 patients in the MACE system and 3D image processing with conventional EGD.

 2. The investigators will compare the grading consistency in the patients who have the
 esophageal varices between the two modalities, using the conventional EGD as the gold
 standard.

 Secondary outcome

 1. The investigators will evaluate the image quality in the MACE system and 3D image
 processing in all participants.

 2. The investigators will compare the detection rate of other gastric lesions such as
 portal hypertensive gastropathy, gastric polyp, and ulcer in the MACE system plus 3D
 image processing with conventional EGD in all participants.

 3. The investigators will evaluate the discomfort using the questionnaire in all
 participants.
Inclusion Criteria:

 -  The investigators plan to include a total of 140 participants in this study, aged from
 20 to 75-year-old.

 Exclusion Criteria:

 -  Those participants with less than 20-year-old, having implanted electronic or magnetic
 devices, pregnant, or unable to swallow the capsule, will be excluded from the study.