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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018357
Receipt No. R000021252
Scientific Title The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Date of disclosure of the study information 2015/09/01
Last modified on 2020/08/10

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Basic information
Public title The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Acronym The usefulness of Carbon dioxide insufflation for DBERC in patients with altered GI anatomy
Scientific Title The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Scientific Title:Acronym The usefulness of Carbon dioxide insufflation for DBERC in patients with altered GI anatomy
Region
Japan

Condition
Condition pancreato-biliary diseases
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Success rate to select the target lumen atthe branch of GI tract.
Key secondary outcomes

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 1) Age: 20 years old or older
2) To consent to an inclusion agreement
3) Patients with altered GI anatomy who have a pancreato-biliary disease (suspected)
Key exclusion criteria A) Acute abdomen
B) severe inflammation is complicated.
C) Pregnancy
D) Poor general condition
E) taking anti-coagulant drugs
F) having severe baseline disease for heart, lung, kidney, or liver.
G) bradycardia or A-V block on ECG
H) previously parpicipated in this study
I) Doctor's decision
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirooka Yoshiki
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakamura Masanao
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
2015 Year 09 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 20 Day
Date of IRB
2015 Year 09 Month 28 Day
Anticipated trial start date
2015 Year 09 Month 28 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2015 Year 07 Month 20 Day
Last modified on
2020 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021252

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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