UMIN-CTR Clinical Trial

Basic information
Public title	Double tract reconstruction versus esophago-gastrostomy after laparoscopic proximal gastrectomy : A randomized Phase III trial to evaluate postoperative body weight change (DREAM trial)
Acronym	Double tract reconstruction vs. esophago-gastrostomy (DREAM trial)
Scientific Title	Double tract reconstruction versus esophago-gastrostomy after laparoscopic proximal gastrectomy : A randomized Phase III trial to evaluate postoperative body weight change
Scientific Title:Acronym	Double tract reconstruction vs. esophago-gastrostomy
Region	Japan

Condition
Condition	gastric cancer esophagogastric junction cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We compare the double tract reconstruction with esophago-gastrostomy after proximal gastrectomy in terms of safety and feasibility.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of over 20% weight loss in one year after surgery
Key secondary outcomes	Incidence rate of average weight loss in one and three year after surgery, Incidence of over 20% weight loss in three year after surgery, Incidence of reflux esophagitis, and anastomotic stricture, anastomotic leakage and all postoperative complications, duration of surgery, blood loss, blood transfusion, Hemoglobin, Total protein, Albumin, QOL evaluation, 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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Esophago-gastrostomy
Interventions/Control_2	B: 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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric carcinoma or esophagogasric junction carcinoma 2) Resectable cancer 3) Not applicable of ESD according to the Japanese classification 4) Excluding esophageal invasion > 3 cm 5) Aged 20 to 90 year 6) PS (ECOG) 0 or 1 7) BMI < 35 8) No history of gastrointestinal surgery 9) No history of chemotherapy or radiotherapy 10) Normal function of the major organs; indicated by a leukocyte count of over 3000 mm3, a platelet count of over 100 000 mm3, aspartate aminotransferase and alanine aminotransferase levels less than 200 IU/L, total bilirubin less than 3 g/dl and creatinine levels less than 2 mg/dl 11) Proven written informed consent 12) Both reconstructions can be safely performed by intraoperative judgment
Key exclusion criteria	1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Pregnancy or breast-feeding 3) Severe mental disease 4) Continuous systemic steroid therapy 5) History of myocardial infarction or unstable angina pectoris within six months 6) Doctors decision not to register to this trial
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Keiji Middle name Last name Hayata
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama841-8510, Japan
TEL	073-441-0613
Email	keiji@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Keiji Middle name Last name Hayata
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama841-8510, Japan
TEL	073-441-0613
Homepage URL
Email	keiji@wakayama-med.ac.jp

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

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University
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
Address	811-1, Kimiidera, Wakayama841-8510, Japan
Tel	073-441-2300
Email	wa-rinri@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	2020 Year 11 Month 01 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	2020 Year 10 Month 05 Day
Date of IRB	2020 Year 10 Month 26 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2029 Year 12 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 10 Month 21 Day
Last modified on	2020 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048148