UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033002
Receipt No. R000037624
Scientific Title Efficacy and safety of reduced port surgery for Colorectal cancer
Date of disclosure of the study information 2018/06/15
Last modified on 2018/12/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and safety of reduced port surgery for Colorectal cancer
Acronym Efficacy and safety of RPS for CRC
Scientific Title Efficacy and safety of reduced port surgery for Colorectal cancer
Scientific Title:Acronym Efficacy and safety of RPS for CRC
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety of reduced port surgery for colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of adverse event in postoperative 1 month or less
Key secondary outcomes Short-term results (amount of blood loss, operative time, and duration of postoperative hospital stay)
Health related QOL score
Long-term results (5-year over-all survival rate and 5-year relapse-free survival rate)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Standard procedure with 4-5 access ports in laparoscopic colorectal cancer excision
Interventions/Control_2 Reduced-port surgery with 1-2 access ports in laparoscopic colorectal cancer excision
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 1) Histological proven colorectal carcinoma, clinical stage 0-III
2) Radical cure resection with D2-D3 lymph node dissection is scheduled.
3) Tumor location; Cecum, Ascending colon, Transverse colon, Descending colon, Sigmoid colon and Rectosigmoid colon
4) Tumor diameter is 5.0cm or smaller
5) 20 years old or more
6) Performance Status (ECOG); 0-1
7) No severe dysfunction of internal organs (Fill everything the following with the inspection within 14 days before registration)
White blood cell count > 2,000/mm3 and < 20,000/ mm3
Platelet number > 50,000/ mm3
Haemoglobin > 8.0 g/dl
AST(GOT) ALT(GPT) < 5 times of facilities standard value upper bound
Serum total bilirubin < 3.0 mg/dl
Serum creatinine < 3.0 mg/dl
8) Patient who is obtaining agreement by explanation document
Key exclusion criteria 1) Severe hypersensitivity
2) Synchronous or metachronous (within 5 years) malignancy other han carcinoma in situ
3) Active infectious disease
4) Severe mental disease
5) Pregnant or lactating women
6) Severe dysfunction of internal organs
7) History of the organ transplantation
8) Preoperative therapy (chemotherapy, radiotherapy and and hormonal therapy, etc.)
9) Improper patient for clinical trial
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Fujii
Organization International University of Health and Welfare, Ichikawa hospital
Division name Gastroenterological surgery
Zip code
Address 6-1-14 kounodai, Ichikawa, Chiba, Japan
TEL 047-375-1111
Email sfujii@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Komako Suga
Organization International University of Health and Welfare, Ichikawa hospital
Division name General affairs department
Zip code
Address 6-1-14 kounodai, Ichikawa, Chiba, Japan
TEL 047-375-1111
Homepage URL http://ichikawa.iuhw.ac.jp/index.html
Email k.suga@kaken-hp.or.jp

Sponsor
Institute International University of Health and Welfare, Ichikawa hospital
Department of Gastroenterological surgery
Institute
Department

Funding Source
Organization International University of Health and Welfare, Research cooperation center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Teikyo University, Department of Surgery
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 Teirin14-021
Org. issuing International ID_1 Teikyo University, Ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国際医療福祉大学市川病院(千葉県)、帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 15 Day

Related information
URL releasing protocol http://ichikawa.iuhw.ac.jp/index.html
Publication of results Unpublished

Result
URL related to results and publications http://ichikawa.iuhw.ac.jp/index.html
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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 03 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
2025 Year 03 Month 31 Day
Date trial data considered complete
2025 Year 03 Month 31 Day
Date analysis concluded
2025 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2018 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.