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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036675
Receipt No. R000036918
Scientific Title Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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