UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer
Title of the study (Brief title)	Phase II trial of LECS and SNNS for elderly patients with early gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Toshiyasu Ojima
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera 811-1, Wakayama, Japan
TEL	073-441-0613
Email	tojima@wakayama-med.ac.jp

Public contact
Name of contact person	Toshiyasu Ojima
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera 811-1, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	tojima@wakayama-med.ac.jp

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

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University, 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)

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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035311