UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041372 |
|---|---|
| Receipt number | R000047233 |
| Scientific Title | A Retrospective cohort study of evaluating the efficacy of ICG Fluorescence imaging for lymphatic flow in Laparoscopic lateral pelvic lymph node dissection for locally advanced middle-low rectal cancer. |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2020/08/10 12:23:57 |
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Basic information
Public title
A Retrospective cohort study of evaluating the efficacy of ICG Fluorescence imaging for lymphatic flow in Laparoscopic lateral pelvic lymph node dissection for locally advanced middle-low rectal cancer.
Acronym
A Retrospective cohort study of evaluating the efficacy of ICG Fluorescence imaging for lymphatic flow in Laparoscopic lateral pelvic lymph node dissection for locally advanced middle-low rectal cancer.
Scientific Title
A Retrospective cohort study of evaluating the efficacy of ICG Fluorescence imaging for lymphatic flow in Laparoscopic lateral pelvic lymph node dissection for locally advanced middle-low rectal cancer.
Scientific Title:Acronym
A Retrospective cohort study of evaluating the efficacy of ICG Fluorescence imaging for lymphatic flow in Laparoscopic lateral pelvic lymph node dissection for locally advanced middle-low rectal cancer.
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the efficacy of lymphatic flow evaluation by near-infrared imaging with indocyanine green (ICG) in laparoscopic lateral pelvic lymph node dissection for increasing the total number of harvested lateral pelvic lymph nodes by comparison with conventinal laparoscopic lateral pelvic lymph node dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the total number of harvested lateral pelvic lymph nodes
Key secondary outcomes
the number of metastatic positive lateral pelvic lymph nodes, the total number of harvested lymph nodes, the number of metastatic positive lymph nodes, postoperative complications (short-term and long term), intraoperative complications, re-operation rate, length of postoperative hospital stay, operation time, volume of blood loss, distal margin, proximal margin, circumferential resection margin, preoperative treatment, postoperative treatment, local recurrence rate, distant recurrence-free survival, relapse-free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
with ICG local administration, 0.25 ml of ICG (2.5mg/ml) was locally injected submucosally into 4 points (the ventral side, dorsal side, left side, and right side) at anal side of tumor under direct vision or endoscopically immediately before surgery (Total 1.0 ml)
Interventions/Control_2
without ICG local administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Laparoscopic lateral pelvic lymph node dissection for rectal cancer
Key exclusion criteria
patients preoperatively diagnosed with distant metastases, patients who underwent total pelvic exenteration, patients who underwent open or robotic surgery, patients with iodine allergy.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Masui |
Organization
Yokosuka kyosai hospital
Division name
Department of surgery
Zip code
238-8558
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL
046-822-2710
hmsi@ykh.gr.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Suwa |
Organization
Yokosuka kyosai hospital
Division name
Department of surgery
Zip code
238-8558
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL
046-822-2710
Homepage URL
hiro0302.suwa@gmail.com
Sponsor or person
Institute
Yokosuka kyosai hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokosuka kyosai hospital clinical research ethics committee
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
Tel
046-822-2710
syomu@ykh.gr.jp
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
| 2020 | Year | 08 | Month | 11 | 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
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047233
