UMIN-CTR Clinical Trial

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

gastric cancer
esophagogastric junction cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Second Department of Surgery, Wakayama Medical University

Institute

Department

Personal name

Organization

Second Department of Surgery, Wakayama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Wakayama Medical University

Address

811-1, Kimiidera, Wakayama841-8510, Japan

Tel

073-441-2300

Email

wa-rinri@wakayama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

10

Month

21

Day

Last modified on

2020

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048148