UMIN-CTR Clinical Trial

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
Email	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
Email	hiro0302.suwa@gmail.com

Sponsor
Institute	Yokosuka kyosai hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047233