UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Acronym	Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Scientific Title	Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Scientific Title:Acronym	Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the presence or absence of tumor cell dispersal during intracorporeal anastomosis and prove that the intracavitary anastomosis is a safe procedure.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of tumor cells in cytology of intraperitoneal lavage water before and after intracorporeal anastomosis and lavage water for stapler
Key secondary outcomes	Evaluation of recurrence (peritoneal dissemination, local recurrence) 3 years after surgery

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	1.Patients diagnosed with colon cancer after undergoing colonoscopy 2.Patients who are judged to be appropriate for treatment by laparoscopic surgery. 3.Patients aged 20 years or older at the time of consent acquisition. 4.Patients who received sufficient explanation in participating in this study, and obtained written consent by the patient's free will after sufficient understanding.
Key exclusion criteria	1. Patients reconstructed using circular stapler 2. Patients with peritoneal dissemination. 3. Patients with conversion to open surgery. 4. Other patients who are deemed by the attending physician to be unable to participate in the research.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Eguchi
Organization	Nagasaki university hospital
Division name	Department of Surgery
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL	095-819-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Adachi
Organization	Nagasaki university hospital
Division name	Department of Surgery
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL	095-819-7316
Homepage URL
Email	t-adachi@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki university hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel	095-819-7229
Email	gaibushikin@ml.nagasaki-u.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	2022 Year 03 Month 18 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	Open public recruiting
Date of protocol fixation	2022 Year 02 Month 23 Day
Date of IRB	2022 Year 03 Month 01 Day
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 03 Month 17 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053843