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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023494
Receipt No. R000027064
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
Date of disclosure of the study information 2016/08/05
Last modified on 2016/08/04

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Basic information
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
Condition Gastric Cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Japanese Gastric Cancer Association
Institute
Department

Funding Source
Organization Japanese Gastric Cancer Association
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 05 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 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
Other related information Study Design: A prospective multicenter observational study

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2016 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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