UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030240 |
|---|---|
| Receipt number | R000034540 |
| Scientific Title | Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/12/12 00:56:41 |
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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
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
jun0926@yokohama-cu.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034540
