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Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study)

Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study) - SPREAD-J study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000037143
Enrollment
500
Registered
2019-06-23
Start date
2018-09-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Sponsors

Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed or suspected with CD who scheduled to have CE for all small bowel observation, and if necessary, were known gastrointestinal tract patency within 2 weeks prior to CE by some method including patency capsule. 2) Patients who understand the contents after receiving a written explanation, and receive written consent for free participation. 3) In the case of a minor, a patient who has obtained consent from a representative (guardian).

Exclusion criteria

Exclusion criteria: 1) Patients with unknown digestive tract patency and patients with gastrointestinal obstruction or fistula. 2) Patients who can not receive CE (Patients with cardiac pacemaker insertion, or other electronic medical devices, or dysphagia or dysphagia symptoms). 3) Patients who are pregnant and may be pregnant. 4) In addition, patients who were judged to be unable to participate in research by responsible researcher or shared doctor.

Design outcomes

Primary

MeasureTime frame
Detection rate and frequency of Crohn's disease lesions by capsule endoscopy (CE)

Secondary

MeasureTime frame
Correlativity of existing Crohn's disease lesion activity evaluation methods (CDAI, CECDAI, Lewis Score), frequency of adverse events, capsule endoscopy acceptance evaluation, usage of patency capsules, and patency capsule related Adverse events

Countries

Japan

Contacts

Public ContactToshiyuki Sakurai

The Jikei University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

to-sakurai@jikei.ac.jp03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026