UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000878
Receipt number 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 14:38:45

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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