UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005120 |
|---|---|
| Receipt number | R000006086 |
| Scientific Title | Clinical trial to investigate safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2013/10/22 13:19:48 |
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Basic information
Public title
Clinical trial to investigate safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy
Acronym
Safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy
Scientific Title
Clinical trial to investigate safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy
Scientific Title:Acronym
Safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and feasibility of Roux-Y with aboral pouch reconstruction after laparoscopically assisted total gastrectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Postoperative hospital stay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients participated in this study undergo laparoscopically assisted total gastrectomy with Roux-Y with aboral pouch reconstruction.
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
1) A gastric cancer patient diagnosed as clinical stage 1A-2B (Japanese Classification of Gastric Carcinoma The 14th Edition).
2) Planned to receive laparoscopically assisted total gastrectomy.
3) ECOG Performance Status Scale: 0-1.
4) Greater than or equal to 20 years of age and less than or equal to 85 years of age.
5) BMI (Body Mass Index): less than or equal to 25 Kg/m2
6) Meet the above-mentioned conditions and able to provide written informed consent.
Key exclusion criteria
1) Neo-adjuvant chemotherapy within four weeks prior to the operation.
2) Coexistence/past history of any inflammatory bowel disease; ulcerative colitis or Crohn's disease.
3) Emergency operation.
4) Double cancer.
5) Resection of adjacent organs except gallbladder
6) Use of anticoagulation and/or antiplatelet agents
7) Dysfunction of major organs.
8) During pregnancy and lactation
9) Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Shibata |
Organization
Tohoku University Hospital
Division name
Division of Gastrointestinal Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tanaka |
Organization
Tohoku University Hospital
Division name
Division of Gastrointestinal Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Homepage URL
n-tanaka@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Division of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
non
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 21 | Day |
Last modified on
| 2013 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006086
