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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010959
Receipt No. R000012825
Scientific Title Obtaining of operative view or visibility in emergency hemostasis for hematoemesis patients in upper body or fornix lesion of stomach
Date of disclosure of the study information 2013/06/14
Last modified on 2016/08/15

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Basic information
Public title Obtaining of operative view or visibility in emergency hemostasis for hematoemesis patients in upper body or fornix lesion of stomach
Acronym Emergency hemostasis using U-shaped inverted overtube
Scientific Title Obtaining of operative view or visibility in emergency hemostasis for hematoemesis patients in upper body or fornix lesion of stomach
Scientific Title:Acronym Emergency hemostasis using U-shaped inverted overtube
Region
Japan

Condition
Condition Bleeding of upper GI tract
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Endoscopists are under pressure to perform these emergency endoscopic treatments, especially in patients with cardiovascular or cerebrovascular diseases who are being treated with antiplatelet and anticoagulant agents or in seriously ill patients who require rapid and reliable hemostasis. In almost all cases, once the bleeding site is visually identified by endoscopy, hemostasis can be achieved using current endoscopic techniques and hemostatic forceps however, if it cannot be visually identified, a surgical procedure is required The presence of blood clots and food residue in the gastric fornix or upper gastric body makes identifying a bleeding exposed vessel impossible. This study aims a method for shortening the hemostasis time and reducing stress for both patients and endoscopists.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Detection rate of exposed vessels and bleeding points using U shaped inverted overtube which in left lateral position, it is difficult to stop the bleeding due to the presence of blood clots and food residue especially in upper body and fornix of the stomach
Key secondary outcomes Procedure time of hemostasis, success rate of hemostasis, rebleeding and visual analogue score of maneuverability of U shaped overtube related to exposed vessels and bleeding points using U shaped inverted overtube which in left lateral position, it is difficult to stop the bleeding due to the presence of blood clots and food residue especially in upper body and fornix of the stomach

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 U shaped inverted overtube which in left lateral position, it is difficult to stop the bleeding due to the presence of blood clots and food residue especially in upper body and fornix of the stomach
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are needed endoscopic hemostasis to stop the bleeding. Among these patients, inclusion criteria is as follows: As endoscopist have performed esophagogastroduodenoscopy (EGD) to those patients lying in the left lateral decubitus position, it is difficult to stop the bleeding due to the presence of blood clots and food residue especially in upper body and fornix of the stomach, and observation has finished from duodenum to lower body of the stomach and there is no exposed vessels.
Key exclusion criteria Except for gastric lesion such as esophageal varix. Gastric varix is included this criteria because it is fornix lesion of the stomach. The lesions of lower body, angle, antrum of the stomach and duodenum are exclusion criteria.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1, Miki, Kida, Kagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa University
Division name Department of Gastroenterology and Neurology
Zip code
Address
TEL
Homepage URL
Email hiro4884@med.kagawa-u.ac.jp

Sponsor
Institute Hirohito Mori
Institute
Department

Funding Source
Organization kagawa University
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
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
2013 Year 06 Month 14 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 Terminated
Date of protocol fixation
2013 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 13 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012825

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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