UMIN-CTR Clinical Trial

Public title

A prospective randomized trial comparing endoscopic stent placement with surgical gastrojejunostomy in gastric outlet obstruction caused by advanced gastric cancer

Acronym

Surgical bypass vs endoscopic stent in malignant gastric outlet obstruction:a randomized trial

Scientific Title

A prospective randomized trial comparing endoscopic stent placement with surgical gastrojejunostomy in gastric outlet obstruction caused by advanced gastric cancer

Scientific Title:Acronym

Surgical bypass vs endoscopic stent in malignant gastric outlet obstruction:a randomized trial

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastroenterology	Surgery in general	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To validate non-inferiority of endoscopic stent to surgical bypass in improving oral intake in gastric outlet obstruction caused by advanced gastric cancer.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Length of the period which oral intake is possible after the intervention

Key secondary outcomes

Safety of the procedure,
Improvement of oral intake,
Survival period after the procedure,
Necessity of additional intervention,
Length of the period which patient is able to stay home,
Quality of life after the procedure

Study type

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

gastrojejunal bypass

Interventions/Control_2

endoscopic stent

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

Gastric adenocarcinoma diagnosed by biopsy

Un resectable cancer

Gastric cancer which does not occur in residual stomach after surgery

Patients who are not be able to take solid meal due to a stricture caused by tumor

Patients who are assessed to be able to have the operations

Blood test which is taken within 2 weeks before registration show following results;
White blood cell count >3000/mm3
Hemoglobin level >7.0 g/dL
Platelet count>100,000 /mm3
Serum total bilirubin level<3.0 mg/dL
Serum creatinine level <2.0 mg/dL

Performance status score 0-2

Patents with survival expectancy more than 3 months

The enrollment in the study is confirmed in written consent

Key exclusion criteria

Cases of emergency operation for gastric perforation,bleeding or etc.

Cases of simultaneous or recurrence of heterochronous active double cancer

Patients with a history of or are suspected of brain metastasis or carcinomatous meningitis

Patients with Disseminated Intravascular Coagulation

Patients with mental disorder or abnormal mental status and are assessed to be difficult to join the study

Patients with severe ascites

Patients with a history of radiotherapy

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Yuichirou Doki

Organization

Osaka University

Division name

Gastroenterological Surgery

Zip code

Address

2-2,Yamadaoka,Suita,Osaka

TEL

+81668793251

Email

ydoki@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shuji Takiguchi

Organization

Osaka University

Division name

Gastroenterological Sugery

Zip code

Address

2-2,Yamadaoka,Suita,Osaka

TEL

+81668793251

Homepage URL

Email

stakiguchi@gesurg.med.osaka-u.ac.jp

Institute

Osaka University Graduate School of Medicine,Department of Gastroenterology

Institute

Department

Personal name

Organization

Osaka University Graduate School of Medicine,Department of Gastroenterology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

市立豊中病院(大阪府)、箕面市立病院(大阪府)、吹田市立病院(大阪府)、済生会千里病院(大阪府)、公立学校共済組合近畿中央病院(大阪府)、関西労災病院（兵庫県）、市立伊丹病院（兵庫県）、県立西宮病院（兵庫県）、大阪府立成人病センター(大阪府)、国立病院機構大阪医療センター(大阪府)、NTT西日本病院(大阪府)、市立堺病院(大阪府)、八尾市立病院(大阪府)、西宮市立中央病院（兵庫県）、市立池田病院(大阪府)、近大奈良病院（奈良県）、大阪船員保険病院(大阪府)、阪南中央病院(大阪府)、ベルランド病院(大阪府)、多根総合病院(大阪府)、国立病院機構呉医療センター（広島県）、大阪府立急性期総合医療センター(大阪府)、大阪府立呼吸器・アレルギー医療センター(大阪府)、市立芦屋病院（兵庫県）、りんくう総合医療センター(大阪府)、市立泉佐野病院(大阪府)、東大阪市立総合病院(大阪府)、大阪警察病院(大阪府)、大阪厚生年金病院(大阪府)、社会保険紀南病院（和歌山県）、大阪中央病院(大阪府)、大阪労災病院(大阪府)、大手前病院(大阪府)、川崎病院(大阪府)、富田林病院(大阪府)、日生病院(大阪府)、清恵会病院(大阪府)、桜橋渡辺病院(大阪府)、ガラシア病院(大阪府)、東宝塚さとう病院（兵庫県）、大阪大学消化器外科(大阪府)　

Date of disclosure of the study information

2014

Year

05

Month

03

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

2014

Year

01

Month

14

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

03

Day

Last modified on

2015

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015550