UMIN-ICDS Clinical Trial

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

Rectal cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University Medical Center, Yokohama, Japan

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2018

Year

05

Month

21

Day

Last modified on

2022

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037233