Capsule Endoscopes Clinical Trial
Official title:
Evaluation of Obscure Gastrointestinal Bleeding Patients With Conventional Capsule Endoscopy and Panoramic Side View Capsule Endoscopy
NCT number | NCT04568343 |
Other study ID # | 2020-07-005B |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | June 6, 2022 |
Verified date | September 2020 |
Source | Taipei Veterans General Hospital, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With the development of endoscopy, patients with suspected gastrointestinal tract disease can
be evaluated with further management. Upper esophageal tract including esophagus, stomach and
duodenum, and colon are easily to be evaluated in daily practice. However, small bowel,
located between stomach and colon, is a long tortuous organ about 4-6 meter long and causing
difficulty in optical evaluation. Since Prof. Swain and Iddan invented video capsule
endoscopy(VCE) from over 20 years ago.[1] VCE is increasingly used in evaluation of small
bowel disease across the world.[2, 3] Originally, VCE is composed of one front lens, with
flashlight and battery to take images during its passage throughout small bowel. Wireless
device were also implanted for transmission of the video signal for further diagnosis.[4] In
recent decades, new generation of VCE have better image quality, longer battery life and more
frequent images taken. Therefore, VCE is recommended as the first line treatment in obscure
gastrointestinal bleeding(OGIB) by multiple societies.[5-7] The efficacy of capsule endoscopy
in evaluating patients with OGIB is good, but not perfect. The current diagnostic yield of
VCE in patients with OGIB is from 35% to 77%.[8-11] Part of OGIB patients still can't be
diagnosed using current conventional capsule endoscopy. The current forward looking lens may
cause some difficulties, including inability to visualize the duodenal papilla, blind points
missed by capsule endoscopy. In recent years, another type of panoramic side view capsule
endoscopy was developed.[12] The CapsoCam Plus (Capsovision) capsule has four cameras
allowing the exploration of the small bowel through 360° lateral viewing and makes papilla
stably visualized. However, this system does not include a recording system so the capsule
endoscope has to be collected by the patient after defecation in order for the film to be
downloaded which may be a disadvantage compared with the conventional capsule endoscopy. In
previous studies, the diagnostic yield of conventional capsule endoscope and panoramic side
view capsule endoscope were comparable while visualization of duodenal papilla is more
frequent in using panoramic side view capsule endoscopy. [13-15] However, most studies are
done in single arm historical control or randomized controlled study, which may be influenced
by the uneven distribution of OGIB patients in both groups. To date only one simultaneous
capsule endoscopy study using both capsule endoscope in the same patient is available to data
using older version of conventional capsule endoscope and panoramic side view capsule
endoscope .[16] The efficiency between two capsule endoscopies were comparable in terms of
diagnostic yield and image quality.
Therefore, we aimed to conduct this study to evaluate the diagnostic efficiency between two
capsule endoscopies. The aim of this study was to evaluate (1) visualization of duodenal
papilla (2) diagnostic concordance (kappa value) of the conventional capsule endoscopy
(Olmypus endocapsule 10) and panoramic side view (CapsoCam Plus) capsule endoscopy in the
same OGIB patient. The clinical experience and satisfaction of both capsule endoscope by the
patient and the physicians will be also be assessed.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 6, 2022 |
Est. primary completion date | June 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients needed to have negative esophagogastroduodenoscopy and colonoscopy for potential bleeding source within 12 months prior to the capsule examination Exclusion Criteria: - suspected or confirmed gastrointestinal tract obstruction, pacemaker use or unwilling to swallow the capsule endoscope |
Country | Name | City | State |
---|---|---|---|
Taiwan | Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ampulla of Vater detection rate | rate of specificaly detect Ampulla of Vater the number of examinations in which the ampulla was clearly identified over the number of the overall number of patients receiving VCE | 24 months | |
Primary | the concordance between the two capsule examinations with a kappa value>0.5 | concordance between the two capsule All endoscopic findings will be systemically recorded according to location, endoscopic features and clinical significance, and in relation to procedure indications, as P0 (low probability), P1 (intermediate pcccrobability), or P2 (high probability) as in previous descriptions [18]. Nonsignificant (P0) lesions and images located outside the small intestine were not considered. For per patient analysis, the final diagnosis of P1 or P2 lesions will be used according to the description of the most important or the most relevant lesion or group of lesions. The sensitivity of each capsule examination will be assessed, with true-positive cases being calculated as the sum of positive cases obtained from the Endocapsule 10 or CapsoCam plus readings, including expert review of discordant cases. In a per lesion analysis, each lesion (up to three main lesions found from capsule reading) or group of lesions will be analyzed independently. | 24 months | |
Secondary | small bowel cleansing quality | The small-bowel cleansing will be scored by estimating the amount of clearly visible mucosa using the scale proposed by Esaki et al. The images of the small intestine will equally be separated into 3 segments according to SBTT. The cleansing quality will be graded according to fluid transparency and mucosal invisibility. The fluid transparency will be graded into grade 1, Clear fluid without obscuring vision, grade 2 Slightly dark fluid minimally obscuring vision, grade 3 Opaque fluid partly obscuring vision and grade 4 Turbid fluid severely obscuring vision. The mucosal invisibility will be graded as Grade 1, <5% in duration of 50% bubbles or residues, grade 2 5%-15%, grade 3 15%-25% and grade 4 >25%. The overall image quality will be categorized into Grade A 3-5, Grade B 6-8 and Grade C 9-12. | 24 months | |
Secondary | technical failure rate | it will be defined as any encountered technical problem due to one or more system components (such as capsule device, downloading system, and/or workstation) influencing the generation of the video. | 24 months | |
Secondary | transit and operation time | Gastric transit time, will be defined as the time between the first and the last gastric image. Small-bowel transit time (SBTT), will be defined as the timeframe between the first and the last small-bowel image. Total capsule endoscope time will be defined as the time between the first and the last image captured by the capsule. Reading time will be defined as the time doctors read the full capsule endoscopic images. | 24 months | |
Secondary | capsule endoscopy completion rate | the number of examinations in which the colon was reached during the operating time over the overall number of patients receiving VCE. | 24 months | |
Secondary | video record reliability | the video record reliability will be evaluated according to a quantitative scoring system as described before, the images of the small intestine will equally be separated into 3 segments according to SBTT. The scoring system is defined as following: 3 points - excellent: when less than 5 total frames and no consecutive non-evaluable frames were observed. 2 points - good: when =5 to <10 total frames or one sequence with <5 consecutive non-evaluable frames were observed. 1 point - fair: when =10 to <15 total frames, or one sequence with <10 consecutive non-evaluable frames were observed. 0 points - poor: when =15 total frames, or multiple sequences, or one sequence with =10 consecutive non-evaluable frames were observed. The video record reliability will be evaluated only in completed capsule endoscopy cases. | 24 months | |
Secondary | diagnostic yield | VCE will be defined as 'positive' when at least one clinically significant finding (P2) was identified; the rate of "positive" VCE (ie, DY) will be calculated. | 24 months | |
Secondary | the physicians' and patients' satisfaction with the capsule endoscopy | For evaluation of the convenience and satisfaction of the patient and physicians about two capsule endoscopy, the physician and patient will be asked to fill a questionnaire about the capsule endoscopy procedure after the capsule endoscopy procedure. | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05546346 -
Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes
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N/A |