A multicenter study comparing the diagnosis rate between a domestic bidirectional camera and an imported Korean camera in suspected small bowel bleeding

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0005591
• Lead Sponsor: Hallym University Medical Center-Dongtan

Brief Summary

Results: Data from 151 of 165 enrolled patients were analyzed. fourteen patients were excluded for technical reason or withdrawal of informed consent. AoV was detected in 32 patients (21%) with MC2000 and 27 patients (17.9 %) with PC3, respectively. Lesions detected at VCE was classified as the Saurin classification (P0, P1, P2 lesions).P1 lesions were identified in 71 patients (47%) with MC2000 and 65 patients (43%) with PC3, respectively. P2 lesions were identified in 43 patients (28.5%) with MC2000 and 39 patients (25.8%) with PC3, respectively. Red spots, angioectasias and diverticulum were more frequently detected at MC 2000 than at PC3 (32% vs 26.5%, 14.6% vs 10.6% and 4% vs 2%). Conclusion: This study shows that MC2000 with dual camera appears to increase the detection rate of SB

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

if any of the patients with suspected small intestine bleeding (1), 2 and 3))
1) Patients who have repeated or sustained iron deficiency anemia, positive for fecal latent blood test, or actual visible bleeding have been determined to conduct capsule endoscopy during medical treatment.
2) Patients who are determined to conduct capsule endoscopy at the time of medical treatment because gastroscopy and colonoscopy did not find any obvious cause of bleeding within at least six months before the capsule endoscopy was implemented.
3) Where an adult aged 19 or older agrees to participate in this research;

Exclusion Criteria

1) In case of hemodynamic instability
2) In the case that the previous test for the entire intestine has not been carried out due to capsule endoscopy,
3) In case of gastrointestinal paralysis, sideways, or stenosis,
4) In case of swallowing disorder
5) In the case of the Zenker Guesthouse,
6) Patients who previously had the ability to operate on small intestine resection
7) Patients with hereditary gastrointestinal polyposis
8) Patients with inflammatory growth disease
9) Patients with terminal renal failure or heart failure have difficulty taking intestinal tablets.
10) Pregnant woman
11) Patients with neuropsychiatric disorders
12) Where voluntary consent of the subject is not possible;
13) Patients with artificial heart aids (e.g., insert-type re-severter, artificial pacemaker, ventricular assist device, etc.) are not excluded at all, but are excluded when it is deemed difficult to take intestinal tablets and proceed with the examination depending on the patient's condition.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection rate of bleeding focus based on Saurin’s classification

Secondary Outcome Measures

Name	Time	Method
detection rate of ampulla of vater