![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000004343 |
Receipt No. | R000004734 |
Scientific Title | Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer |
Date of disclosure of the study information | 2010/10/07 |
Last modified on | 2013/10/16 |
Basic information | ||
Public title | Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer | |
Acronym | Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer | |
Scientific Title | Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer | |
Scientific Title:Acronym | Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer | |
Region |
|
Condition | ||
Condition | gastric cancer | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer and to prove the non-inferiority of the antecolic route. |
Basic objectives2 | Bio-equivalence |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Gastric emptying after the operation |
Key secondary outcomes | Nutrient state
Complication of the operation Quality of life after the operation Operation time Blood loss during the operation Endoscopic remark |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | from 2009/10/2 to 2012/9/30
The number of object is 30 per year Patients were distributed to antecolic group and retrocolic group using a table of random numbers. |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients with gastric cancer
POHOCY0 Curability A or B ECOG PS 0 or 1 No past history of surgery of the upper abdomen, and no past history of operation with int |
|||
Key exclusion criteria | When non curative factor is found.
When we judged that we cannot continue the operation because of unexpected complications. When the patient wished to discontinue. When the operator decided to discontinue the operation. |
|||
Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | National center for global health and medicine | ||||||
Division name | Department of eneral surgery | ||||||
Zip code | |||||||
Address | 1-21-1 Toyama Shinjuku-ku,Tokyo | ||||||
TEL | 03-3202-7181 | ||||||
qpsaho@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | National center for global health and medicine | ||||||
Division name | Department of general surgery | ||||||
Zip code | |||||||
Address | 1-21-1 Toyama Shinjuku-ku,Tokyo | ||||||
TEL | 03-3202-7181 | ||||||
Homepage URL | |||||||
qpsaho@yahoo.co.jp |
Sponsor | |
Institute | Department of gerenral surgery,National center for global health and medicine |
Institute | |
Department |
Funding Source | |
Organization | National center for global health and medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
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 | 国立国際医療研究センター(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004734 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |