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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036286
Receipt No. R000041330
Scientific Title Prospective observational study to assess the safety of laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Date of disclosure of the study information 2019/03/25
Last modified on 2019/03/24

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Basic information
Public title Prospective observational study to assess the safety of laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Acronym Laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Scientific Title Prospective observational study to assess the safety of laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Scientific Title:Acronym Laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Region
Japan

Condition
Condition primary colorectal cancer with synchronous liver metastases
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of postoperative complication at or greater than Clavien-Dindo grade 3, duration of postoperative hospital stay
Key secondary outcomes Operation time, Blood loss, Intraoperative complication, Conversion to open surgery, Overall survival, Disease free survival

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 Patients with primary colorectal cancer with synchronous liver metastases in accordance with the following criteria

1)no gender
2)age over 20 years old
3)Patients who will undergo laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis in accordance with the following criteria.
・the maximum tumor diameter less than or equal to 3 cm, only up to 2 liver metastasis.
.liver lesions in segment 2-6 (The Couinaud classification)
・liver tumors without proximity to major vessel
・patients who will undergo laparoscopic partial hepatectomy or left lateral segmentectomy.

4)the patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for the participation of this study.
Key exclusion criteria 1) When the laparoscopic simultaneous resection could be a long surgery as described below
・low rectal cancer requiring super-low anterior resection or intersphincteric resection (ISR)
.liver metastasis requiring anatomical resection (greater or equal to subsegmentectomy, except for left lateral segmentectomy).
2) Patients judged unsuitable as research subjects

Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nagano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2264
Email hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Yukio
Middle name
Last name Tokumitsu
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2264
Homepage URL
Email yt790604@yamaguchi-u.ac.jp

Sponsor
Institute Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Center For Clinical Research, Yamaguchi University Hospital
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel 0836-22-2428
Email me223@yamaguchi-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
2019 Year 03 Month 25 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
2019 Year 01 Month 30 Day
Date of IRB
2019 Year 01 Month 30 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Laparoscopic simultaneous resection of primary colorectal carcinoma and liver metastasis may reduce a patient's stress and total hospital stay. Prospective observational study can assess the safety of laparoscopic simultaneous resection in daily practice.

Management information
Registered date
2019 Year 03 Month 24 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041330

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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