UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Acronym	Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Scientific Title	Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Scientific Title:Acronym	Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the best reconstruction method after laparoscopic proximal gastrectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of weight loss 1 year after surgery.
Key secondary outcomes	Operative time, Complication, The percentage of conversion to laparotomy, Nutritional assessment, Reflux esophagitis, Recurrence-free survival, Overall Survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The arm of esophagogastrostomy.
Interventions/Control_2	The arm of double tract reconstruction.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically diagnosed unresectable advanced or recurrent gastric or esophagogastric junction adenocarcinoma. 2) Scheduled for Proximal gastrectomy. 3) cStage I. 4) Age over 20 years old. 5) PS:0-2(ECOG). 6) BMI under 30. 8) No history of upper abdominal surgery 9) No history of chemotherapy, radiation, hormone therapy, molecular target drugs. 6) Written informed consent.
Key exclusion criteria	1) With double cancer. 2) Have an infectious disease that requires systemic treatment. 3) Pregnant or lactating. 4) Psychosis. 5) Administration of steroids. 6) History of myocardial infarction. 7) With uncontrolled hypertension. 8) With uncontrolled diabetes. 9) With respiratory disease requiring continuous oxygen administration. 10) Renal failure requiring hemodialysis.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Yamasaki
Organization	Graduated School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2-E2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3251
Email	myamasaki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Yamasaki
Organization	Graduated School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2-E2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3251
Homepage URL
Email	myamasaki@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Oasaka University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka International Cancer Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University
Address	2-2-E2, Yamadaoka, Suita City, Osaka
Tel	06-6879-3251
Email	myamasaki@gesurg.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	19206-2
Org. issuing International ID_1	Osaka International Cancer Institute
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 27 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	Preinitiation
Date of protocol fixation	2020 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 15 Day
Last follow-up date	2027 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	2020 Year 06 Month 27 Day
Last modified on	2020 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046307