UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016496
Receipt number R000019124
Scientific Title A Phase II study of robot assisted laparoscopic distal gastrectomy for clinical stage IA gastric cancer
Date of disclosure of the study information 2015/02/10
Last modified on 2019/08/14 15:49:43

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Basic information

Public title

A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer

Acronym

A Phase II study of robot assisted gastrectomy

Scientific Title

A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer

Scientific Title:Acronym

A Phase II study of robot assisted gastrectomy

Region

Japan


Condition

Condition

gastric cancer with cStage IA

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of robot assisted laparoscopic distal gastrectomy for cStage IA gastric cancer not applicable for endoscopic submucosal dissection in the introductory period

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Incidence rate of intra-abdominal complications requiring treatment (postoperative bleeding, anastomotic leakage, intraabdominal abscess, pancreatic fistula)

Key secondary outcomes

Overall survival, Relapse-free survival, Completion rate of robot assisted laparoscopic surgery, Proportion of open conversion, Short-term postoperative course


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Robot assisted laparoscopic distal gastrectomy

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric adenocarcinoma
2) Diagnosed as cStageIA(T1N0) by endoscopy and contrast enhanced CT
3) Not applicable for endoscopic submucosal dissection
4) Regarded as curatively resected by distal gastrectomy with tumor location being M, L, ML, or LM
5) Performance status of 0 or 1
6) Body Mass Index of less than 30
7) No prior surgery in the upper abdomen
8) No prior chemotherapy or radiation therapy for cancers including gastric cancer
9) Informed consent obtained from the patient

Key exclusion criteria

1) Active mutiple primary cancers (carcinoma in situ or mucosal cancer were not included in active cancers)
2) Being pregnant or brestfeeding
3) Continuous steroid use (oral or intravenous)
4) With myocardial infarction in 6 months or with unstable angina
5) With uncontrollable hypertension
6) With uncontrollable diabetes mellitus
7) With respiratory disorder requiring continuous oxgen therapy

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Watanabe

Organization

Kitasato University

Division name

Department of surgery

Zip code

2520374

Address

1-15-1, Kitasato, Sagamihara, Kanagawa, Japan

TEL

042-778-8111

Email

gekaw@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Hosoda

Organization

Kitasato University

Division name

Department of surgery

Zip code

2520374

Address

1-15-1, Kitasato, Sagamihara, Kanagawa, Japan

TEL

042-778-8111

Homepage URL


Email

k.hosoda@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

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

Research Ethics Committee of the Kitasato University School of Medicine

Address

1-15-1 Kitasato, Sagamihara, Japan

Tel

0427788111

Email

rinrib@med.kitasato-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

2015 Year 02 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.journalofsurgicalresearch.com/article/S0022-4804(19)30054-X/fulltext

Number of participants that the trial has enrolled

25

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

Main results already published

Date of protocol fixation

2015 Year 02 Month 01 Day

Date of IRB

2015 Year 02 Month 13 Day

Anticipated trial start date

2015 Year 02 Month 13 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 09 Day

Last modified on

2019 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name