UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021117 |
|---|---|
| Receipt number | R000024365 |
| Scientific Title | Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2016/02/20 22:21:45 |
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Basic information
Public title
Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation
Acronym
laparoscopic D1 plus lymphadenectomy for rectal cancer
Scientific Title
Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation
Scientific Title:Acronym
laparoscopic D1 plus lymphadenectomy for rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer without lymph node metastasis on preoperative computed tomography scans
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal lymphadenectomy for the rectal cancer without lymphadenopathy on preoperative CT scans
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease specific survival rate and recurrence free survival rate were compared for at least three-year follow-up.
Key secondary outcomes
Feasibility of defining more than 10 mm of the minor axis of the lymph nodes as positive
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A laparoscopic low or high anterior resection with a D2 lymphadenectomy was performed. The inferior mesenteric artery was exposed at the root of the left colic artery branching and clipped and dissected preserving the left colic artery. The iliac or obturator lymph nodes were not dissected.
Interventions/Control_2
A laparoscopic low or high anterior resection with D1 plus lymphadenectomy was performed.
The inferior mesenteric artery was dissected by using a surgical stapler with implantable staples or exposed and clipped at the site between the root of left colic artery and superior rectal artery. We tried to cut and dissect as close to the root of the left colic artery as possible from the information of preoperative CT scans and intraoperative findings, when we used surgical stapler with implantable staples. The iliac or obturator lymph nodes were not dissected.
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
| 44 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with rectal cancer without lymph node metastasis by colonoscopies and CT scans
Key exclusion criteria
Patients diagnosed with lymph node metastasis, who were treated by chemotherapy and/or radiation therapy preoperatively were excluded. One patient who died of pneumonia within 30 days after surgery was also excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yanagita |
Organization
Kameda medical center
Division name
Department of gastroenterological surgery
Zip code
Address
929 Higashi-cho Kamogawa city Chiba prefecture, Japan
TEL
81-4-7099-1111
tkshyngtx@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yanagita |
Organization
Kameda medical center
Division name
Department of gastroenterological surgery
Zip code
Address
929 Higashi-cho Kamogawa city Chiba prefecture, Japan
TEL
81-4-7099-1111
Homepage URL
tkshyngtx@gmail.com
Sponsor or person
Institute
Takeshi Yanagita
Institute
Department
Personal name
Funding Source
Organization
Kameda medical center
Organization
Division
Category of Funding Organization
Self funding
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
Kameda medical center (Chiba)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 21 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 20 | Day |
Last modified on
| 2016 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024365
