UMIN-CTR Clinical Trial

Public title

Phase II trial of laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer

Acronym

Phase II trial of LECS and SNNS for elderly patients with early gastric cancer

Scientific Title

Phase II trial of laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer

Scientific Title:Acronym

Phase II trial of LECS and SNNS for elderly patients with early gastric cancer

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of in laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer selected to undergo additional resection after endoscopic treatment

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Postoperative one-week complication rates in laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery

Key secondary outcomes

Surgical process (operative time, intraoperative bleeding, rates of laparotomy transition), postoperative course (oral intake, length of safety), rates of late complications (from discharge to 3 years after surgery), postoperative quality of life (QOL), overall survival (OS), disease specific survival (DSS), disease free survival (DFS)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hybrid endoscopic and laparoscopic partial gastrectomy for the scar of endoscopic treatment
Closing the site of gastrectomy by laparoscopic hand-sewn saturation.
Sentinel lymph nodes navigation surgery in laparoscopic
The sentinel lymph nodes and surrounding sentinel lymphatic basin are dissected out from the fatty tissue.

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Gastric cancer requiring additional resection after ESD (All non-applied lesions, non-curative resection with absolute adaptive lesion or adaptive enlarged lesion)
2)Performance status 0 and 1
3)Over 75 years old patient
4)No history of preoperative chemotherapy for gastric cancer
5)Plt => 100,000/mm3 Creatinine <= 2.0 mg/dl AST <= 200 IU/L ALT <= 200 IU/L T-bil <= 2.0 mg/dl Hb => 8.0 g/dl
6)Patients who gave written informed consent before entry in this study

Key exclusion criteria

1)Ischemic heart disease
2)Liver cirrhosis, active hepatitis
3)Interstitial pneumonia
4)Haemodialysis
5)Both malignant disorder
6)Severe abdominal adhesion
7)Doctor's decision not to register to this regimen

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Toshiyasu Ojima

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera 811-1, Wakayama, Japan

TEL

073-441-0613

Email

tojima@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Ojima

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera 811-1, Wakayama, Japan

TEL

073-441-0613

Homepage URL

Email

tojima@wakayama-med.ac.jp

Institute

Second Department of Surgery, Wakayama Medical University, School of Medicine

Institute

Department

Personal name

Organization

Second Department of Surgery, Wakayama Medical University, School of Medicine

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

2018

Year

02

Month

01

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

Preinitiation

Date of protocol fixation

2018

Year

01

Month

19

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

25

Day

Last modified on

2018

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035311