UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011390 |
|---|---|
| Receipt number | R000013340 |
| Scientific Title | A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2014/12/19 15:49:15 |
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Basic information
Public title
A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Acronym
A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Scientific Title
A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Scientific Title:Acronym
A prospective feasibility study of reduced-port laparoscopic distal gastrectomy for clinical stage I gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the non-inferiority of incidence of postoperative complication of reduced-port laparoscopic distal gastrectomy with lymph node dissection compared with conventional laparoscopic distal gastrectomy for clinical stage IA or IB gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of postoperative complication
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reduced-port laparoscopic gastrectomy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma.
2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0).
3) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achivable by distal gastrectomy.
4) Aged 20 to 80 years.
5) Body mass index less than 30.
6) PS (ECOG) of 0 or 1.
7) No history of upper abdominal surgery.
8) No prior treatment of chemotherapy or radiation therapy against any other malignancies.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2) Infectious disease with systemic therapy indicated.
3) Body temperature of 38 or more degrees Celsius.
4) Women during pregnancy or breast-feeding.
5) Severe mental disease.
6) Continuous systemic steroid therapy.
7) Unstable angina pectoris, or history of myocardial infarction within six months.
8) Uncontrollable hypertension.
9) Uncontrollable diabetes millutus.
10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Graduate School of Medicine, Nagoya University
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2250
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie TANAKA |
Organization
Graduate School of Medicine, Nagoya University
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2250
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
| 2013 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
