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

NCT04568343 | Unknown DMC FDA Device

• 1 other identifier: 2020-07-005B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Capsule Endoscopes

Keywords

Capsule Endoscopes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• small bowel cleansing quality

  24 months

• technical failure rate

  24 months

• transit and operation time

  24 months

• capsule endoscopy completion rate

  24 months

• video record reliability

  24 months

Study Arms (1)

small bowel bleeding patient

EXPERIMENTAL

with suspicious small bowel bleeding,patient will recieve Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule later for evaluations

Device: Capsule endoscopy

Interventions

Capsule endoscopy DEVICE

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

Also known as: The Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule

small bowel bleeding patient

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients needed to have negative esophagogastroduodenoscopy and colonoscopy for potential bleeding source within 12 months prior to the capsule examination

You may not qualify if:

• suspected or confirmed gastrointestinal tract obstruction, pacemaker use or unwilling to swallow the capsule endoscope

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (21)

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  PMID: 10839527 BACKGROUND

• Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.

  PMID: 29539652 BACKGROUND

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  PMID: 28063287 BACKGROUND

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  PMID: 26755883 BACKGROUND

• ASGE Standards of Practice Committee; Gurudu SR, Bruining DH, Acosta RD, Eloubeidi MA, Faulx AL, Khashab MA, Kothari S, Lightdale JR, Muthusamy VR, Yang J, DeWitt JM. The role of endoscopy in the management of suspected small-bowel bleeding. Gastrointest Endosc. 2017 Jan;85(1):22-31. doi: 10.1016/j.gie.2016.06.013. Epub 2016 Jun 30. No abstract available.

  PMID: 27374798 BACKGROUND

• Pennazio M, Spada C, Eliakim R, Keuchel M, May A, Mulder CJ, Rondonotti E, Adler SN, Albert J, Baltes P, Barbaro F, Cellier C, Charton JP, Delvaux M, Despott EJ, Domagk D, Klein A, McAlindon M, Rosa B, Rowse G, Sanders DS, Saurin JC, Sidhu R, Dumonceau JM, Hassan C, Gralnek IM. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2015 Apr;47(4):352-76. doi: 10.1055/s-0034-1391855. Epub 2015 Mar 31.

  PMID: 25826168 BACKGROUND

• Gerson LB, Fidler JL, Cave DR, Leighton JA. ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding. Am J Gastroenterol. 2015 Sep;110(9):1265-87; quiz 1288. doi: 10.1038/ajg.2015.246. Epub 2015 Aug 25.

  PMID: 26303132 BACKGROUND

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  PMID: 22389234 BACKGROUND

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  PMID: 16825907 BACKGROUND

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  PMID: 21924720 BACKGROUND

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  PMID: 18787463 BACKGROUND

• Friedrich K, Gehrke S, Stremmel W, Sieg A. First clinical trial of a newly developed capsule endoscope with panoramic side view for small bowel: a pilot study. J Gastroenterol Hepatol. 2013 Sep;28(9):1496-501. doi: 10.1111/jgh.12280.

  PMID: 23701674 BACKGROUND

• Tontini GE, Wiedbrauck F, Cavallaro F, Koulaouzidis A, Marino R, Pastorelli L, Spina L, McAlindon ME, Leoni P, Vitagliano P, Cadoni S, Rondonotti E, Vecchi M. Small-bowel capsule endoscopy with panoramic view: results of the first multicenter, observational study (with videos). Gastrointest Endosc. 2017 Feb;85(2):401-408.e2. doi: 10.1016/j.gie.2016.07.063. Epub 2016 Aug 8.

  PMID: 27515129 BACKGROUND

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  PMID: 29369240 BACKGROUND

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  PMID: 24285122 BACKGROUND

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  BACKGROUND

MeSH Terms

Interventions

Capsule Endoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: September 29, 2020
• Study Start: June 1, 2020
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

TW (1)