UMIN-CTR Clinical Trial

Public title

A prospective multicenter observational study of surgical palliation examining postoperative quality of life in patients treated for malignant gastric outlet obstruction caused by incurable advanced gastric cancer

Acronym

gastric outlet obstruction (GOO)

Scientific Title

A prospective multicenter observational study of surgical palliation examining postoperative quality of life in patients treated for malignant gastric outlet obstruction caused by incurable advanced gastric cancer

Scientific Title:Acronym

gastric outlet obstruction (GOO)

Region

Japan

Condition

Gastric Cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study was to prospectively evaluate patient-reported outcomes and observational outcome measures of patients who underwent palliative surgery for GOO. In addition, we sought to identify the clinical and demographic variables associated with those outcomes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in QOL for patients undergoing surgical palliation for GOO caused by incurable primary gastric cancer.

Key secondary outcomes

Postoperative improvement of oral intake, safety of surgical procedures, and postoperative overall survival.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) histologically proven primary gastric adenocarcinoma presenting with GOO diagnosed clinically, endoscopically, or radiographically (2) presence of non-curable factors confirmed by both enhanced abdominal computed tomography (CT) and exploratory laparoscopy or laparotomy (3) no oral intake or extremely poor oral intake requiring parenteral nutrition (4) age of 20 years or more (5) surgically fit (6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 through 2 (7) adequate organ function within 14 days before enrollment, and (8) written informed consent (IC).

Key exclusion criteria

(1) active bleeding or perforation of the gastric tumour demanding an urgent surgery; (2) active coexisting cancer (synchronous coexisting cancer and recurrence of metachronous cancer) showing symptoms; (3) clinically suspected brain metastasis or carcinomatous meningitis; (4) presence of disseminated intravascular coagulation (DIC); and (5) severe mental disorder.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Motoki Ninomiya, MD.

Organization

Hiroshima City Hospital

Division name

Surgery

Zip code

Address

Motomachi 7-33, Naka-ku, Hiroshima, Japan

TEL

082-221-2291

Email

motoki-n@city-hosp.naka.hiroshima.jp

Name of contact person

1st name
Middle name
Last name	Kazumasa Fujitan, MDi

Organization

Osaka Prefectural General Medical Center

Division name

Surgery

Zip code

Address

Bandaihigashi 3-1-56, Sumiyoshi-ku, Osaka, Japan

TEL

06-6692-1201

Homepage URL

Email

fujitani@onh.go.jp

Institute

Japanese Gastric Cancer Association

Institute

Department

Personal name

Organization

Japanese Gastric Cancer Association

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

函館五稜郭病院(北海道庁)、山形県立中央病院(山形県)、国立病院機構仙台医療センター(宮城県)、宮城県立がんセンター(宮城県)、新潟県立がんセンター新潟病院(新潟県)、富山県立中央病院(富山県)、石川県立中央病院(石川県)、帝京大学医学部附属病院(東京都)、東京都健康長寿医療センター(東京都)、東邦大学医療センター大森病院(東京都)、慶応義塾大学医学部院附属病院(東京都)、静岡県立静岡がんセンター(静岡県)、静岡県立総合病院(静岡県)、名古屋大学医学部附属病院(愛知県)、愛知県立愛知がんセンター中央病院(愛知県)、岐阜大学医学部附属病院(岐阜県)、岐阜市民病院(岐阜県)、兵庫医科大学附属病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、国立病院機構四国がんセンター(愛知県)、広島市立安佐市民病院(広島県)、島根大学医学部附属病院(島根県)、大分大学医学部附属病院(大分県)、国立病院機構熊本医療センター(熊本県)、大阪府立急性期・総合医療センター(大阪府)、国立病院機構大阪医療センター(大阪府)、神奈川県立がんセンター(神奈川県)、広島市立広島市民病院(広島県)、市立貝塚病院(大阪府)、湘南鎌倉総合病院(神奈川県)、千葉県がんセンター(千葉県)、堺市立総合医療センター(大阪府)、西宮市立中央病院(兵庫県)、大阪労災病院(大阪府)、市立豊中病院(大阪府）

Date of disclosure of the study information

2016

Year

08

Month

05

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

No longer recruiting

Date of protocol fixation

2013

Year

02

Month

07

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design: A prospective multicenter observational study

Registered date

2016

Year

08

Month

04

Day

Last modified on

2016

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027064