UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study
Acronym	LPG double tract
Scientific Title	Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study
Scientific Title:Acronym	LPG double tract
Region	Japan

Condition
Condition	Gastric cancer in the upper third
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety in double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Weight loss rate 6 months after surgery
Key secondary outcomes	Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis, usage rate of PPI, incidence rate of GERD).

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	Maneuver
Interventions/Control_1	Laparoscopic proximal gastrectomy with double-tract reconstruction
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically proven gastric carcinoma in the upper third 2. Performance status 0 and 1 3. Aged 20 to 85 year 4. No history of surgery for gastric cancer (Endoscopic treatment is tolerant) 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	22

Research contact person
Last name of lead principal investigator	1st name Toshiyasu Middle name Last name Ojima
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Zip code	641-8510
Address	Kimiidera 811-1, Wakayama
TEL	0734410613
Email	tojima@wakayama-med.ac.jp

Public contact
1st name of contact person	1st name Toshiyasu Middle name Last name Ojima
Organization	Wakayama Medical University School of Medicine
Division name	Second Department of Surgery
Zip code	641-8510
Address	Kimiidera 811-1, Wakayama
TEL	0734410613
Homepage URL
Email	tojima@wakayama-med.ac.jp

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

Funding Source
Organization	Wakayama Medical University, School of Medicine, Second Department of Surgery
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	Wakayama Medical University Hospital
Address	811-1 Kimiidera, Wakayama
Tel	0734410613
Email	tojima@wakayama-med.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 05 Month 08 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	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 08 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036918