Unique ID issued by UMIN | UMIN000000878 |
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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 |
A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
Randomized study for reconstruction after distal gastrctomy
A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
Randomized study for reconstruction after distal gastrctomy
Japan |
Curative distal gastrectomy for gastric cancers
Gastrointestinal surgery |
Malignancy
NO
To investigate the superiority of Roux-en-Y method to Billroth I method for reconstruction after distal gastrectomy
Efficacy
Exploratory
Pragmatic
Phase II
body weight loss rate at one year afer surgery
incidence of delayed gastric empty, reflux esphagitis and surgical complication
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
Billroth-I method
Roux-en-Y method
20 | years-old | <= |
90 | years-old | >= |
Male and Female
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
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
320
1st name | |
Middle name | |
Last name | Yuichiro Doki, MD |
Osaka University, Graduate School of Medicine
Gastroenterological Surgery
2-2-E2, Yamadaoka, Siuta, Osala, 565-0871, Japan
06-6879-3251
1st name | |
Middle name | |
Last name | Yuichiro Doki, MD |
Osaka University, Graduate School of Medicine
Gastroenterological Surgery
2-2-E2, Yamadaoka, Siuta, Osala, 565-0871, Japan
06-6879-3251
ydoki@surg2.med.osaka-u.ac.jp
Clinical surgery research group/The supporting center for clinilcal and education
none(self funding)
Self funding
Japan
NO
2007 | Year | 11 | Month | 05 | Day |
Unpublished
No longer recruiting
2005 | Year | 07 | Month | 01 | Day |
2005 | Year | 08 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2007 | Year | 11 | Month | 05 | Day |
2012 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001057
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