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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008014
Receipt No. R000008003
Scientific Title Feasibility Study of Delta-Shaped Anastomosis in Totally Laparoscopic Billroth I Gastrectomy using Tri-Staple
Date of disclosure of the study information 2012/05/23
Last modified on 2015/05/25

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Basic information
Public title Feasibility Study of Delta-Shaped Anastomosis in Totally Laparoscopic Billroth I Gastrectomy using Tri-Staple
Acronym Feasibility Study of Delta-Shaped Anastomosis in Totally Laparoscopic Billroth I Gastrectomy using Tri-Staple
Scientific Title Feasibility Study of Delta-Shaped Anastomosis in Totally Laparoscopic Billroth I Gastrectomy using Tri-Staple
Scientific Title:Acronym Feasibility Study of Delta-Shaped Anastomosis in Totally Laparoscopic Billroth I Gastrectomy using Tri-Staple
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to determine if intracorporeal delta-shaped anastomosis following distal gastrectomy using Tri-Staple is not only clinically feasible but also advantageous as compared to that using conventional staplers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short-term surgical outcomes related to anastomosis are assessed, including the incidence of anastomotic leakage, stenosis, bleeding, and stasis.
Key secondary outcomes maneuverability, hemostability

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 Tri-Staple
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. The patient is 20 years and older.
2. The patient is scheduled to undergo gastrectomy with Delta anastomisis.
3. Performance status 0-1 (ECOG)
4. The patient has no history of upper abdominal surgery (except cholecystectomy for mild inflammation and appendectomy).
5. The patient is healthy organ function.
6. The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
Key exclusion criteria 1) Pregnant, suspected pregnant, or nursing.
2) Undergoing continuing systemic administration (intravenous or oral) of steroids.
3) Complicated by uncontrolled diabetes mellitus (HbA1c>8.0).
4) Allergic to nickel chromium
5) Judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
6) Judged unsuitable for study participation by the investigator for any other reason.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Uyama
Organization Fujita Health University School of Medicine
Division name Upper GI Surgery
Zip code
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Suda
Organization Fujita Health University School of Medicine
Division name Upper GI Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Covidien Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
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 藤田保健衛生大学(愛知県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 23 Day
Last modified on
2015 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008003

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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