UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036286
Receipt number 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 23:14:39

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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