UMIN-CTR Clinical Trial

Public title

Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.

Acronym

Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.

Scientific Title

Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.

Scientific Title:Acronym

Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.

Region

Japan

Condition

stomach and colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Age, sex, height, weight, BMI, PS
2. Past medical history:Health history, operation history
3. laboratory test values
4. pathological classification associated tumor, number of lymph nodes harvested, venous invasion
5. Operative information
procedure, reconstruction method, anesthesia time, surgical time, operative bleeding loss, Lymph node dissection number, completed in robot-assisted laparoscopic surgery, the reason of unsuccessful completion
6. Intraoperative and postoperative stomach cancer complication
7. Intraoperative and postoperative colorectal cancer complication
8. presence or absence of post-operation treatment and relapse, post-operation treatment of a therapeutic regimen, survival period, the start time of oral ingestion after operation, postoperative length of stay
9. The number of robot-assisted implemented, analysis of the operation time

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

A robot assisted operation using 'da Vinci Xi'
period of ntervention: 5 years

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed as being stomach and colorectal cancer
2. Pre-operation test diagnosed as stomach and colorectal cancer which can be resected curatively
3. Patients diagnosed as cannot be applied to ESD
4. ECOG performance status scale: 0 or 1, ASA: 1 or 2
5. Age <=20 years old to >=75
6. Written informed consent is obtained

Key exclusion criteria

1. Anemic condition (hemoglobin >10g/dl)
2. The patient who has active multiple cancers
3. Long-term administration of steroids
4. Patients with psychiatric diseases
5. With uncontrolled diabetes composition
6. With uncontrolled hypertension composition
7. With respiratory disorder that need continuous supply supplemental oxygen composition
8. With central nervous system disease composition (intracranial disease)
9. With glaucomatous composition
10. The patient who pose a risk for developing intracranial hypertension by head- tilt
Other conditions judged ineligible by physician

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Masaki Kitazono

Organization

Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital

Division name

Surgery / Gastrointestinal surgery

Zip code

Address

14-3 Nagata-cho, Kagoshima-city, Japan

TEL

0992269111

Email

m-kitazono@nanpuh.or.jp

Name of contact person

1st name
Middle name
Last name	clinical research coordinater

Organization

Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital

Division name

Clinical Research Support Office

Zip code

Address

14-3 Nagata-cho, Kagoshima-city, Japan

TEL

0992269111

Homepage URL

Email

crc-kenkyu@nanpuh.or.jp

Institute

Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital

Institute

Department

Personal name

Organization

Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

11

Month

25

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

08

Day

Last follow-up date

2018

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

08

Month

31

Day

Last modified on

2018

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026828