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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000878
Receipt No. R000001057
Scientific Title A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
Date of disclosure of the study information 2007/11/05
Last modified on 2012/11/05

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Basic information
Public title A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
Acronym Randomized study for reconstruction after distal gastrctomy
Scientific Title A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
Scientific Title:Acronym Randomized study for reconstruction after distal gastrctomy
Region
Japan

Condition
Condition Curative distal gastrectomy for gastric cancers
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the superiority of Roux-en-Y method to Billroth I method for reconstruction after distal gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes body weight loss rate at one year afer surgery
Key secondary outcomes incidence of delayed gastric empty, reflux esphagitis and surgical complication

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Billroth-I method
Interventions/Control_2 Roux-en-Y method
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) Primary treatment for histologically proven adenocarcinoma of the stomach. 2)Indication for distal gastrectomy due to tumor localization 3) Reconstruction feasible for both Billroth I and Roux-en-Y 4) Aged 20 to 90 years old 5) PS (ECOG) of 0 or 16) Curable operation ( Curability B or more according to Japanese Classification for Gastric carcinomas) 7) Written informed consent
Key exclusion criteria 1) History of laparotomy excluding laparoscopic cholecyctectomy and addendectomy (skin incision less than 5cm) 2) Non-curative factors proven by pre-operative examinations 3) Pre-operatiev chemotherapy 4) Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancers 5) Metachronous malignancies within 5 years or with tumor recurrence 6) Severe respiratory dysfunction 7) History of myocardial infarction of two-step Master positive by ECG 8) Liver cirrhosis or chronic active hepatitis 9) Chronic renal failure with hemodialysis 10) Uncontrolled diabetes (HbA1C 9.0 or more) 11) Reflux esophagitis (LA grade A or more) 12) Other unfeasible factors to perform study safely, approved by attending surgeon
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki, MD
Organization Osaka University, Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Siuta, Osala, 565-0871, Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Doki, MD
Organization Osaka University, Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Siuta, Osala, 565-0871, Japan
TEL 06-6879-3251
Homepage URL
Email ydoki@surg2.med.osaka-u.ac.jp

Sponsor
Institute Clinical surgery research group/The supporting center for clinilcal and education
Institute
Department

Funding Source
Organization none(self funding)
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

Other administrative information
Date of disclosure of the study information
2007 Year 11 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
2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 11 Month 05 Day
Last modified on
2012 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001057

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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