Esophageal Varices in Cirrhosis of the LiverNCT04588974
Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient
An observational study of Esophageal Varices in Cirrhosis of the Liver, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Esophageal Varices in Cirrhosis of the Liver
- What is being tested?
- magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: The investigators plan to include a total of 140 participants in this study. 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. 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. Another 40 healthy volunteers without known gastrointestinal disease will be enrolled as the control group.
Who may be able to join
- The investigators plan to include a total of 140 participants in this study, aged from 20 to 75-year-old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Endoscopy Center for Diagnosis and Treatment, Department of Medicine, Taipei Veterans General Hospital
Taipei, 112
Hung-En Lin, MD, 886228712121 ext. 2574, helin@vghtpe.gov.tw
About this study
Official title: Magnetic-assisted Capsule Endoscope System With or Without 3D Images in Esophageal Varices Detection Compared With Conventional Esophagogastroduodenoscopy in Cirrhotic Patients
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.
Read the 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.
- Being tested
- magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images
- Keywords
- esophageal varices, capsule endoscopy
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D imagesDevice
Also called Esophagogastroduodenoscopy (Olympus GIF-H290)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images | |
| 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. Receives: Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images | |
| Control | Another 40 volunteers with GI symptoms but no known gastrointestinal disease will be enrolled as the control group. Receives: Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images |
What is being measured
The primary outcome is the main question the study is designed to answer.
esophageal detection rate
The investigators compare the detection rate of esophageal varices in the cirrhotic patients in the MACE system and 3D image processing with conventional EGD.
Measured: upto 1 week after MACE and EGD
esophageal grading
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.
Measured: upto 1 week after MACE and EGD
Secondary outcomes (3)
image quality
The investigators evaluate the image quality in the MACE system and 3D image processing in all participants.
Measured: upto 1 week after MACE and EGD
gastric lesion comparison
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.
Measured: upto 1 week after MACE and EGD
preference in MACE or EGD
The investigators evaluate the discomfort using the questionnaire in all participants.
Measured: upto 1 week after MACE and EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices in Cirrhosis of the LiverStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Insight Medical Solution, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588974
- Sponsor's protocol ID
- 2020-09-003C
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic-assisted Capsule Endoscope System With or Without 3D Images in Esophageal Varices Detection Compared With Conventional Esophagogastroduodenoscopy in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04588974
- Acronym / sponsor ID
- 2020-09-003C
- Keywords
- esophageal varices, capsule endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Insight Medical Solution, Inc.
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D imagesSixty-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. |
| Follow-up | – | Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D imagesThirty-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. |
| Control | – | Device: magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D imagesAnother 40 volunteers with GI symptoms but no known gastrointestinal disease will be enrolled as the control group. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to include a total of 140 participants in this study. 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. 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. Another 40 healthy volunteers without known gastrointestinal disease will be enrolled as the control group.
Key inclusion criteria (1 listed)
- The investigators plan to include a total of 140 participants in this study, aged from 20 to 75-year-old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D imagesAlso: Esophagogastroduodenoscopy (Olympus GIF-H290)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. | Device | Control, Follow-up, Screening |
Primary outcome
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.
esophageal grading
Time frame: upto 1 week after MACE and EGD
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.
3 secondary outcomes
image quality
Time frame: upto 1 week after MACE and EGD
gastric lesion comparison
Time frame: upto 1 week after MACE and EGD
preference in MACE or EGD
Time frame: upto 1 week after MACE and EGD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices in Cirrhosis of the Liver, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-En Lin, MD (886228712121 ext. 2574, helin@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esophageal detection rate (time frame: upto 1 week after MACE and EGD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.