UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008014 |
|---|---|
| Receipt number | 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 08:37:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
