UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer.
Acronym	EssentiAL study
Scientific Title	Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer.
Scientific Title:Acronym	EssentiAL study
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 is to clarify the usefulness of blood flow evaluation by near infrared imaging using indocyanine green (ICG) as prevention of anastomotic leak after rectal anterior resection for rectal cancer by randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anastomotic leakage rate
Key secondary outcomes	Anastomotic leakage rate(Grade B+C) Fluorescence time at the oral side anastomotic site Rate of the additional transection of the proximal colon toward the oral side Length of the additional transection of the proximal colon toward the oral side Rates of complications within 30 days after surgery Rates of complications during surgery Reoperation rate Postoperative hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Evaluation of blood flow by near infrared imaging using indocyanine green
Interventions/Control_2	control
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who are histologically proven to be rectal cancer 2. The lower edge of the tumor is within 12 cm from the anal margin 3. Patients diagnosed with Stage 0-3 in preoperative diagnostic imaging 4. Patients who are scheduled for rectal resection with intestinal anastomosis (including ISR) 5. Patients with General State Performance Status (ECOG) 0 to 2 6. Patients whose age at registration is 20 years or older 7. Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination 1 White blood cell count> 3,000 / mm 3 2 platelet> 100,000 / mm 3 3 GOT <100 IU / L 4 GPT <100 IU / L 5 Total bilirubin <2.0 mg / dl 6 Cr <2.0 mg / dl 8. About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant
Key exclusion criteria	1. Patients who are allergic to iodine or indocyanine green 2. Preoperative intestinal obstruction patients 3. Patients planning simultaneous resection of other organs due to double cancer 4. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer 5. Patients with intraperitoneal infection (peritonitis or abdominal abscess) 6. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.) 7. Pregnancy and patients with fear thereof 8. Other patients judged inappropriate by the examining physician
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Takemasa
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8556
Address	Nishi 17, Minami 1 jyo, Cyuou-ku, Sapporo
TEL	0116112111
Email	itakemasa@sapmed.ac.jp

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

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Stryker Japan K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Certified Review Board
Address	5F, 1-1-1, Fukuura, Kanazawa-ku, Yokohama
Tel	046-261-5656
Email	jun0926@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	CRB3180007
Org. issuing International ID_1	Yokohama City University Certified Review Board
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 04 Month 01 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 12 Month 04 Day
Date of IRB	2018 Year 09 Month 07 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 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	2017 Year 12 Month 04 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034540