Evaluation of Obscure Gastrointestinal Bleeding Patients With Conventional Capsule Endoscopy and Panoramic Side View Capsule Endoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ampulla of Vater detection rate
研究概览
简要总结
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.
详细描述
Materials and Methods Patients 30 Patients with occult gastrointestinal bleeding aged 20-85 years old will be enrolled from Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital. Patients needed to have negative esophagogastroduodenoscopy and colonoscopy for potential bleeding source within 12 months prior to the capsule examination. Patient with suspected or confirmed gastrointestinal tract obstruction, pacemaker use or unwilling to swallow the capsule endoscope will be excluded. Female at child bearing age will receive urine HCG test for pregnancy evaluation. Pregnant patients will be excluded. All patients will be given informed consent before inclusion.
Capsule Endoscopy procedure 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.
Small-bowel preparation will be performed in patients before capsule ingestion as routine practice and previously published guidelines. [19] The patients will take one pack of GI-Klean powder(polyethylene glycol) in 1000ml water followed by 1000ml water at 6-8 pm the night before capsule endoscopy. Then they will take another pack of GI-Klean powder(polyethylene glycol) in 1000ml water followed by 1000ml water at 5AM on the morning on the day of capsule endoscopy.
On the day of examination, the patients will take 10ml of simethicone fluid first. Then they'll ingest the two capsules, with 1.5 hour between and in a randomized order (using sealed envelopes). After capsule endoscopy entered small bowel, the patient will take a light meal at least 4 hours after the 2nd capsule endoscope ingestion. They'll take dinner as usual. The capsule endoscope will be collected by the patient using a specified capsule collecting system during defecation. If no capsule endoscope was noted in the stool in 3 days. The patient will received through 20mg sennosides on the 3rd night. The patients will return back the capsule endoscope, antenna and recorder after getting the capsule endoscope. For patient who didn't collect capsule endoscope in 15 days, abdominal x-ray plain film will be taken to evaluate the status of capsule endoscope.
Capsule endoscopy review For each case, the two capsule films will read in a randomized order by three experienced physicians (one >250 VCE examinations, two >100 VCE examinations). None of the physicians had experience of panoramic side view capsule endoscopy(<5) before this study. The two readings will be done blindly. The reading frames will be were available to each reader, and suggested not faster than a rate of 15 images per second. The cases will be classified into concordant positive, concordant negative, and discordant cases. For discordant cases, a third reviewer will conduct the clarification of the CE images for confirmation and confirmed during a conference by all three experienced readers. An image per image comparison will be performed and the complete film will be read a second time when necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients needed to have negative esophagogastroduodenoscopy and colonoscopy for potential bleeding source within 12 months prior to the capsule examination
排除标准
- •suspected or confirmed gastrointestinal tract obstruction, pacemaker use or unwilling to swallow the capsule endoscope
结局指标
主要结局
Ampulla of Vater detection rate
时间窗: 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
the concordance between the two capsule examinations with a kappa value>0.5
时间窗: 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.
次要结局
- technical failure rate(24 months)
- small bowel cleansing quality(24 months)
- transit and operation time(24 months)
- diagnostic yield(24 months)
- the physicians' and patients' satisfaction with the capsule endoscopy(24 months)
- capsule endoscopy completion rate(24 months)
- video record reliability(24 months)