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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014783
Receipt No. 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

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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
Email 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
Email kubotak@yokohma-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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