UMIN-CTR Clinical Trial

Basic information
Public title	Indocyanine green fluorescence imaging to reduce the risk of anastomotic leakage in laparoscopic low anterior resection for rectal cancer: A Large, Multicenter, Propensity Score Matched Cohort Study
Acronym	Fluorescence imaging in laparoscopic low anterior resection
Scientific Title	Indocyanine green fluorescence imaging to reduce the risk of anastomotic leakage in laparoscopic low anterior resection for rectal cancer: A Large, Multicenter, Propensity Score Matched Cohort Study
Scientific Title:Acronym	Fluorescence imaging in laparoscopic low anterior resection
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate the effect of ICG fluorescence imaging (ICG-FI) on AL rates during laparoscopic low anterior resection (LAR) for rectal cancer, compared to a propensity score matched series of laparoscopic LAR performed without ICG-FI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint of this study was the rate of AL within 30 days after surgery.
Key secondary outcomes	Secondary endpoints were operative time, blood loss, postoperative complications, reoperation within 30 days after surgery, length of hospital stays, oncological clearance, and the rate of changing the surgical plan.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligibility criteria were 1) rectal cancer located within 15 cm from anal verge with histologically proven adenocarcinoma or signet-ring cell carcinoma and 2) having undergone primary rectal cancer resection.
Key exclusion criteria	The exclusion criteria were 1) multiple primary cancers, 2) a history of treatment for other pelvic malignancy, 3) open or robotic surgery cases, and 4) emergent cases.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center, Yokohama, Japan
Division name	Department of Surgery, Gastroenterological Center
Zip code	232-0024
Address	4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL	045-261-5656
Email	jun0926@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center, Yokohama, Japan
Division name	Department of Surgery, Gastroenterological Center
Zip code	232.0024
Address	4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL	045-261-5656
Homepage URL
Email	jun0926@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center, Yokohama, Japan
Institute
Department

Funding Source
Organization	Self funding
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	Y-NEXT IRB
Address	1-1-1, Fukuura, Kanazawa-ku, Yokohama, 236-0004. Japan
Tel	045-370-7976
Email	rinri@yokohama-cu.ac.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	2018 Year 05 Month 21 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	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This retrospective multi-institutional study was conducted to evaluate the AL rates after laparoscopic LAR for rectal cancer at three institutions of Yokohama Clinical Oncology Group in Japan from September 2014 to December 2017. The study protocol was approved by the Ethical Advisory Committee of Yokohama City University Medical Center and the institutional review board of each participating hospital before the study was initiated. Patient data were collected from clinical report forms. Eligibility criteria were 1) rectal cancer located within 15 cm from anal verge with histologically proven adenocarcinoma or signet-ring cell carcinoma and 2) having undergone primary rectal cancer resection. The exclusion criteria were 1) multiple primary cancers, 2) a history of treatment for other pelvic malignancy, 3) open or robotic surgery cases, and 4) emergent cases. The primary endpoint of this study was the rate of AL within 30 days after surgery. Secondary endpoints were operative time, blood loss, postoperative complications, reoperation within 30 days after surgery, length of hospital stays, oncological clearance, and the rate of changing the surgical plan.

Management information
Registered date	2018 Year 05 Month 21 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037233