Unique ID issued by UMIN | UMIN000022318 |
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Receipt number | R000023975 |
Scientific Title | Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial. |
Date of disclosure of the study information | 2016/06/01 |
Last modified on | 2023/05/21 09:27:34 |
Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial.
Preservation of celiac branch of the vagus nerve
Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial.
Preservation of celiac branch of the vagus nerve
Japan |
Early gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the nutritional impact of preserving the celiac branch of the vagus nerve on nutritional status after gastrectomy for early gastric cancer.
Efficacy
Primary endpoint:
The change of serum albumin, total protein, and hemoglobin one year after gastrectomy
Secondary endpoint:
1. The change of serum albumin, total protein, and hemoglobin two or three year after gastrectomy.
2. The change of serum albumin, total protein, and hemoglobin two or three year after gastrectomy according to operative procedure.
3. The change of body weight one, two, and three year after gastrectomy.
4. Operative time and blood loss
5. Short-term outcome
6. Assesment of clinical outocome using questionnaire one, two, and three year after gastrectomy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
2
Treatment
Maneuver |
Preservation of the celiac branch of the vagus nerve
No preservation of the celiac branch of the vagus nerve
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) The patients diagnosed as gastric adenocarcinoma with cT1N0
2) PS 0-1
3) Informed consent is obtained
1) Remnant gastric cancer
2) Gasrectomy with any other organs (not including gall bladder)
3) Any other malignancy which is including synchronal double cancer, but they are not including the carcinoma in situ or intramucosal cancer diagnosed as cure by local procedure
4) Severe respiratory disease
5) Severe cardiac disease
6) Severe hepatic cirrhosis or active hepatitis
7) Severe chronic renal failure
8) Patient who is judged as an inappropriate case by the doctor in charge
90
1st name | Kohei |
Middle name | |
Last name | Wakatsuki |
Nara Medical University
Surgery
6348522
840, Shijo-cho, Kashihara, Nara, Japan
0744-22-3051
kohei@naramed-u.ac.jp
1st name | Kohei |
Middle name | |
Last name | Wakatsuki |
Nara Medical University
Surgery
6348522
840, Shijo-cho, Kashihara, Nara, Japan
0744-22-3051
kohei@naramed-u.ac.jp
Nara Medical University
Dep. of Surgery
None
Other
Nara Medical University Ethics Committee
840, Shijo-cho, Kashihara, Nara, Japan
0744223051
ino_rinri@naramed-u.ac.jp
NO
2016 | Year | 06 | Month | 01 | Day |
Unpublished
56
No longer recruiting
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 07 | Month | 01 | Day |
2023 | Year | 12 | Month | 31 | Day |
2016 | Year | 05 | Month | 15 | Day |
2023 | Year | 05 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023975
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