- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588974
Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient
Magnetic-assisted Capsule Endoscope System With or Without 3D Images in Esophageal Varices Detection Compared With Conventional Esophagogastroduodenoscopy in Cirrhotic Patients
Study Overview
Status
Conditions
Detailed Description
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
- 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.
- 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
- The investigators will evaluate the image quality in the MACE system and 3D image processing in all participants.
- 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.
- The investigators will evaluate the discomfort using the questionnaire in all participants.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hung-En Lin, MD
- Phone Number: 2574 886228712121
- Email: helin@vghtpe.gov.tw
Study Locations
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Taipei, Taiwan, 112
- Recruiting
- Endoscopy Center for Diagnosis and Treatment, Department of Medicine, Taipei Veterans General Hospital
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Contact:
- Hung-En Lin, MD
- Phone Number: 2574 886228712121
- Email: helin@vghtpe.gov.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening
Sixty-five cirrhotic patients 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 with or without 3D image processing.
|
The patient will undergo both diagnostic tests within two days, a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
Other Names:
|
Follow-up
Thirty-five cirrhotic patients with a history of endoscopy-confirmed esophageal varices will be included for the follow-up examination by using the magnetic-assisted capsule endoscope system with or without 3D images.
|
The patient will undergo both diagnostic tests within two days, a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
Other Names:
|
Control
Another 40 volunteers with GI symptoms but no known gastrointestinal disease will be enrolled as the control group.
|
The patient will undergo both diagnostic tests within two days, a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
esophageal detection rate
Time Frame: upto 1 week after MACE and EGD
|
The investigators compare the detection rate of esophageal varices in the cirrhotic patients in the MACE system and 3D image processing with conventional EGD.
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upto 1 week after MACE and EGD
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esophageal grading
Time Frame: upto 1 week after MACE and EGD
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The investigators compare the grading consistency in the patients who have the esophageal varices between the two modalities, using the conventional EGD as gold standard.
|
upto 1 week after MACE and EGD
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
image quality
Time Frame: upto 1 week after MACE and EGD
|
The investigators evaluate the image quality in the MACE system and 3D image processing in all participants.
|
upto 1 week after MACE and EGD
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gastric lesion comparison
Time Frame: upto 1 week after MACE and EGD
|
The investigators 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.
|
upto 1 week after MACE and EGD
|
preference in MACE or EGD
Time Frame: upto 1 week after MACE and EGD
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The investigators evaluate the discomfort using the questionnaire in all participants.
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upto 1 week after MACE and EGD
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-09-003C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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