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Evaluation of Obscure Gastrointestinal Bleeding Patients With Conventional Capsule Endoscopy and Panoramic Side View Capsule Endoscopy

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ClinicalTrials.gov Identifier: NCT04568343
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Capsule Endoscopes Device: Capsule endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule will be used. The Endocapsule is 26mm x 11mm in size and 3.3g in weight. It has 160° angle of view with 12 hours of battery life, 2 frame per second sampling rate. One antenna unit will be packed on the patient's waist during examination adjacent to a recorder. [17] The CapsoCam Plus capsule is 31mm x 11mm in size and 4g in weight. It has a field of view of 360° with at least 15 hours of battery life, takes 20 images per second maximum, (4 frames per second from each of the four cameras). No other accessories are needed during the procedure.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Obscure Gastrointestinal Bleeding Patients With Conventional Capsule Endoscopy and Panoramic Side View Capsule Endoscopy
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 6, 2022
Estimated Study Completion Date : June 6, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: small bowel bleeding patient
with suspicious small bowel bleeding,patient will recieve Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule later for evaluations
Device: Capsule endoscopy
We use two capsule endoscopy for evaluation their diagnostic yield. Patient will recieve different capsule endoscopy:The Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule
Other Name: The Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule




Primary Outcome Measures :
  1. Ampulla of Vater detection rate [ Time Frame: 24 months ]
    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

  2. the concordance between the two capsule examinations with a kappa value>0.5 [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. small bowel cleansing quality [ Time Frame: 24 months ]
    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.

  2. technical failure rate [ Time Frame: 24 months ]
    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.

  3. transit and operation time [ Time Frame: 24 months ]
    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.

  4. capsule endoscopy completion rate [ Time Frame: 24 months ]
    the number of examinations in which the colon was reached during the operating time over the overall number of patients receiving VCE.

  5. video record reliability [ Time Frame: 24 months ]
    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.

  6. diagnostic yield [ Time Frame: 24 months ]
    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.

  7. the physicians' and patients' satisfaction with the capsule endoscopy [ Time Frame: 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568343


Locations
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Taiwan
Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: YANG-PO WANG, MD & PhD    886228712121 ext 2574    ypwang@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Publications:
Pachofszky T., H.P., Madl C., World's largest series with CapsoCam®. Feasibility, completion and detection rate of the new Generation of capsule endoscope with a 360° lateral panoramic view - A single center retrospective study., in UEG Week. 2019: Barcelona, Spain

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04568343    
Other Study ID Numbers: 2020-07-005B
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Capsule Endoscopes
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases