UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014783 |
|---|---|
| Receipt number | R000017174 |
| Scientific Title | The efficacy of preventive clipping in frenulum after endoscopic papillecomy |
| Date of disclosure of the study information | 2014/08/07 |
| Last modified on | 2018/11/30 21:10:15 |
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Basic information
Public title
The efficacy of preventive clipping in frenulum after endoscopic papillecomy
Acronym
Preventive frenulum clipping for ESP
Scientific Title
The efficacy of preventive clipping in frenulum after endoscopic papillecomy
Scientific Title:Acronym
Preventive frenulum clipping for ESP
Region
| Japan |
Condition
Condition
Tumor of the ampulla of Vater
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of preventive endoscopic clipping in the frenulum after ESP
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety and feasibility of clipping in the frenulum after ESP
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
endoscopic clipping
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.age more than 20 yeras old
2.no bleeding tendency
3.tumor proved before ESP
Key exclusion criteria
1.age less than 20years old
2.bleeding tendency
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kubota |
Organization
Yokohama City University
Division name
Hepatogastroenterology
Zip code
Address
Fukuura3-9, Kanazawa
TEL
045-787-2800
kubotak@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | saito satoru |
Organization
Yokohama City University
Division name
Hepatogastroenterology
Zip code
Address
Fukuura3-9, Kanazawa
TEL
045-787-2800
Homepage URL
kubotak@yokohma-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 07 | 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
This study involved 40 consecutive patients who underwent preventive clipping of the frenulum just after EP. The outcome data were compared with those of the previous 40 patients in whom no preemptive clipping had been performed (no-clipping group) The clipping procedure was successful in all patients. As compared to the no-clipping group, the rate of bleeding (p = 0.026) and period of hospital stay (p < 0.001) were significantly reduced in the clipping group. There was no difference in the procedure time between the two groups. Furthermore, the incidence rates of pancreatitis and perforation were comparable in the two groups. There was no mortality in either group. The bleeding was noted in the frenulum area rather than at any other site in 90.9% of cases. Preventive clipping at the frenulum after EP is an effective, safe, rational and economical method to reduce the incidence of post-procedure bleeding, without prolonging the procedure time, or increasing the risk of post-procedure pancreatitis perforation.
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
