UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036319 |
|---|---|
| Receipt number | R000040827 |
| Scientific Title | Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease |
| Date of disclosure of the study information | 2019/04/06 |
| Last modified on | 2019/07/20 13:14:27 |
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Basic information
Public title
Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Acronym
Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Scientific Title
Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Scientific Title:Acronym
Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between capsule endoscopy and fecal calprotectin in small bowel Crohn's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Lewis score of small bowel capsule endoscopy and fecal calprotectin
Key secondary outcomes
1. Correlation between fecal calprotectin and Alb, CRP, or ESR
2. Correlation between fecal calprotectin and HBI
3. Correlation between fecal calprotectin and CECDAI
4. Cleansing level of small bowel capsule endoscopy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients adapted for small bowel capsule endoscopy
2. Patients confirmed diagnosis of Crohn's disease
3. Patients who are confirmed patency by patency capsule
4. Patients with Ileal, Ileocollic, or aphthous-type Crohn's disease
5. Patients without history of abdominal surgery
Key exclusion criteria
1. Patients with malignant tumor
2. Patients with acute abdomen
3. Patients with serious acute inflammation
4. Patients with pregnant woman
5. Patients who cannot be confirmed GI patency under patency capsule
6. Patient's general health is extremely poor, Patients who has risk for performing endoscopy such as ileus, perforation, pancreatitis, respiratory disorder, cardiovascular disorder, acquired hemophilia, stenosis, large ulcer, or tumor
7. Patients with active lesions in colon
8. Patients with stoma
9. Patients with history of abdominal surgery
10. Patients with habitual NSAIDs consumption
11. Colonic Crohn's disease
12. Patients used to participate in this trial
13. Also, patients who are judged not suitable for this trial by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Teruyuki |
| Middle name | |
| Last name | Takeda |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL
092-921-1011
take5times@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Teruyuki |
| Middle name | |
| Last name | Takeda |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL
092-921-1011
Homepage URL
take5times@hotmail.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital, Sanyo Chemical Industries, Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka, Japan
Tel
092-921-1011
chikushirinsho@adm.fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福岡大学筑紫病院（福岡県）、久留米大学病院（福岡県）、九州大学病院（福岡県）、芦屋中央病院（福岡県）、戸畑共立病院（福岡県）、佐賀大学医学部付属病院（佐賀県）、長崎大学病院（長崎県）、熊本大学病院（熊本県）、宮崎大学医学部付属病院（宮崎県）、鹿児島大学病院（鹿児島県）、鮫島病院（鹿児島県）、琉球大学医学部付属病院（沖縄県）、浦添総合病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We perform Capsule endoscopy, Colonoscopy, and Fecal Calprotectine.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040827
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