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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040288
Receipt No. R000045964
Scientific Title Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Date of disclosure of the study information 2020/05/01
Last modified on 2020/05/01

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Basic information
Public title Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Acronym Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Scientific Title Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Scientific Title:Acronym Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Region
Japan

Condition
Condition Ampullary tumor
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy, prognosis, and treatment of endoscopic papillectomy (EP).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical success rate of EP
Key secondary outcomes 1. Comparison of preoperative biopsy (biopsy site and number of biopsies) and postoperative pathology.
2. Primary disease, length of stay and cost of hospitalization.
3. Long-term postoperative recurrence rate and recurrence pattern.
4. Relationship between procedures of EMR and procedure related complications.
5. Relationship between prophylactic method and procedure related complications.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have endoscopic papillectomy.
Key exclusion criteria None.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Eisuke
Middle name
Last name Iwasaki
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL +81-3-5363-3790
Email e-iwa@keio.jp

Public contact
Name of contact person
1st name Atsuto
Middle name
Last name Kayashima
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL +81-3-5363-3790
Homepage URL
Email kayashima@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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 Keio University School of Medicine IRB
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel +81-3-5363-3790
Email kayashima@keio.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 東京医科大学 臨床医学系消化器内科学分野(東京)、慶應義塾大学医学部消化器内科(東京)、みやぎ健診プラザ(宮城)、藤田医科大学 ばんたね病院(名古屋)、福岡大学筑紫病院(福岡)、東邦大学医療センター大森病院(東京)、埼玉医科大学国際医療センター(埼玉)、手稲渓仁会病院 消化器病センター(北海道)、名古屋大学大学院医学系研究科(愛知)、鹿児島大学病院(鹿児島)、順天堂大学医学部附属順天堂医院(東京)、岡山大学病院(岡山)、神戸大学医学部附属病院(兵庫)、自治医科大学附属病院(栃木)、獨協医科大学病院(栃木)、長崎大学病院(長崎)、聖マリアンナ医科大学病院(神奈川)、北里大学病院(神奈川)、愛知がんセンター(愛知)、九州大学病院(福岡)、横浜市立大学付属病院(神奈川)、東京大学病院(東京)、大阪がんセンター(大阪)、佐世保市総合医療センター(長崎)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 01 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
2020 Year 03 Month 25 Day
Date of IRB
2020 Year 02 Month 19 Day
Anticipated trial start date
2020 Year 03 Month 25 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None.

Management information
Registered date
2020 Year 05 Month 01 Day
Last modified on
2020 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045964

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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