UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001787 |
|---|---|
| Receipt number | R000002154 |
| Scientific Title | Limited surgery for early gastric cancer using sentinel node navigation |
| Date of disclosure of the study information | 2009/03/19 |
| Last modified on | 2010/03/23 16:39:33 |
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Basic information
Public title
Limited surgery for early gastric cancer using sentinel node navigation
Acronym
Limited surgery for early gastric cancer using sentinel node navigation
Scientific Title
Limited surgery for early gastric cancer using sentinel node navigation
Scientific Title:Acronym
Limited surgery for early gastric cancer using sentinel node navigation
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of limited gastrectomy with dissection of lymph node stations where sentinel nodes belong in T1N0M0 gastric cancer patients with negative sentinel node biopsy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We survey postoperative complications, disease recurrence, and postoperative physical conditions after this procedure.
Key secondary outcomes
We evaluate the sensitivity for detecting lymph node metastasis by sentinel node biopsy using frozen section.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with T1N0M0 gastric cancer with a tumor diameter of 4 cm or less.
Key exclusion criteria
Patients who meet the criteria for endoscopic treatment, women during pregnancy or the lactation period, and patients with severe comorbidity.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishikura |
Organization
National Defense Medical College Hospital
Division name
Department of Surgery
Zip code
Address
3-2, Namiki, Tokorozawa, Japan
TEL
04-2295-1637
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Tsujimoto |
Organization
National Defense Medical College Hospital
Division name
Department of Surgery
Zip code
Address
3-2, Namiki, Tokorozawa, Japan
TEL
04-2295-1637
Homepage URL
Sponsor or person
Institute
Department of Surgery, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Boei-igaku-shinkokai Incorporated Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2002 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although false negative results of sentinel node biopsy cannot be ignored in gastric cancer surgery, dissection of lymph node stations where sentinel node belong may minimize the possibility of leaving metastasis behind in case of negative sentinel node biopsy.
Until the end of 2008, there were no operative mortalities or morbidities. All patients undergoing the limited surgery had no lymph node metastasis by postoperative pathology, and survived without any recurrence.
Management information
Registered date
| 2009 | Year | 03 | Month | 19 | Day |
Last modified on
| 2010 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002154
