UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046950 |
|---|---|
| Receipt number | R000053572 |
| Scientific Title | A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstruction |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/08/23 13:09:28 |
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Basic information
Public title
A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstruction
Acronym
A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstruction
Scientific Title
A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstruction
Scientific Title:Acronym
A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstruction
Region
| Japan |
Condition
Condition
gastric caner
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the clinical efficacy of performing the B-II method compared to the conventional R-Y method in elderly patients with gastric cancer after distal gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss rate 1 month after surgery
Key secondary outcomes
Weight loss rate at discharge, 3 months, 6 months, and 1 year after surgery
Postoperative complications
Nutritional status
Blood loss, operative time, postoperative hospital stay
Frequency of reflux esophagitis, residual gastritis, and dumping
Compliance with postoperative adjuvant chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Billroth-II
Interventions/Control_2
Roux-en-Y
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1-1 Primary gastric cancer diagnosed as adenocarcinoma by biopsy.
1-2 Patients who are scheduled for distal gastrectomy for gastric cancer.
1-3 Patients in whom preoperative examination findings suggest that Billroth-I reconstruction is inappropriate, and reconstruction by Billroth-II or Roux-en-Y reconstruction is possible.
1-4 Age 75 years or older
1-5 Performance status 0-2 ECOG classification
1-6 Patients who have been diagnosed as being able to undergo R0 resection.
1-7 Patients who have given written consent to participate in this study.
1-8 Patients who have not undergone previous surgery involving open bowel resection.
1-9 Patients with sufficient bone marrow, liver, and kidney function.
Key exclusion criteria
2-1) Patients with non-curative factors such as peritoneal dissemination, liver metastasis, distant metastasis, or invasion of other organs (T4b) in pre-treatment and preoperative examinations (abdominal CT, abdominal ultrasound, x-ray, etc., in addition to general blood tests).
2-2) Patients with concurrent multiple cancers other than stomach. However, carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer are not exclusion criteria.
2-3) Patients with heterogeneous multiple cancers that have recurred after treatment or have not passed more than 5 years after treatment. (2-3) Heterogeneous multiple cancers that have recurred after treatment or have not been treated for more than 5 years. 2-4) Patients with emphysema, etc.
2-4) Patients with severe respiratory disorders such as emphysema.
2-5) Patients with a definite history of myocardial infarction. Or cases that can be judged positive by Master two step.
2-6) Cirrhosis or
2-6) Patients with liver cirrhosis or active hepatitis.
2-7) Patients with chronic renal failure requiring dialysis.
2-7) Patients with chronic renal failure requiring dialysis. 2-8) Diabetic patients with poor control (HbA1c: 8.0 or higher).
(2-9) Patients who are judged by the investigator to be inappropriate for the safe conduct of the study.
2-10) Patients with reflux esophagitis (LA classification A or higher).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
0668793251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Tanaka |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
0668793251
Homepage URL
ktanaka@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Clinical Study Group of Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, Osaka University
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
0668793251
ykurokawa@gesurg.med.osaka-u.ac.jp
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
| 2022 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053572
