Unique ID issued by UMIN | UMIN000019208 |
---|---|
Receipt number | R000020255 |
Scientific Title | Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor. |
Date of disclosure of the study information | 2015/10/10 |
Last modified on | 2020/07/09 14:01:10 |
Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor.
Safety of LECS for duodenal tumor.
Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor.
Safety of LECS for duodenal tumor.
Japan |
duodenal tumor
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
The aim of this study is to evaluate the safety of laparoscopic-endoscopic cooperative surgery for duodenal tumor.
Safety
Confirmatory
The incidence rate of anastomotic leakage of the duodenum within one month after operation.
The incidence rate of adverse event (Clavien-Dindo classification, GradeII and higher) and operation related death within one month after opeartion, and proportion of conversion to open surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Laparoscopic-endoscopic cooperative surgery
20 | years-old | <= |
80 | years-old | >= |
Male and Female
For inclusion in the study, patients must fulfill the following requirements preoperatively:
1) duodenal tumor is 5 cm or smaller and difficult having en-bloc resection by endoscopic mucosal resection.
2) Aged 20 to 80 year
3) PS (ECOG)0 or 1
4) provided written informed consent
1) no history of gastrointestinal surgery except appendectomy due to appendicitis.
2) no history of chemotherapy or radiotherapy.
3) all laboratory data must fulfill the following requirements within 56 days prior to trial registration.
1. white blood cell count; 3,000/mm3 or more
2. blood platelet count; 100,000/mm3 or more
3. Aspartate Aminotransferase; 100 IU/L or lower
4. Alanine aminotransferas; 100 IU/L or lower
5. total bilirubin; 2.0 mg/dL or lower
6. creatinine; 1.5 mg/dL or lower
4) without informed consent
5) patients who were judged inadequate by clinical trial principal investigator or subinvestigator
20
1st name | Shingo |
Middle name | |
Last name | Kanaji |
Kobe University
Gastrointestinal Surgery
6500017
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
078-382-5925
kanashin@med.kobe-u.ac.jp
1st name | Shingo |
Middle name | |
Last name | Kanaji |
Kobe University
Gastrointestinal Surgery
6500017
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
078-382-5925
kanashin@med.kobe-u.ac.jp
Gastrointestinal Surgery, Kobe University
None
Self funding
Kobe University Hospital CTRC
Kobe University Hospital CTRC
078-382-6515
kainyu@med.kobe-u.ac.jp
NO
神戸大学病院(兵庫県)
2015 | Year | 10 | Month | 10 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020255
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/den.13705
20
Sixteen tumors were located in the second portion, three in the first portion, and one in the third portion of the duodenal region. The median operative time was 225 (134-361) min and the median blood loss was 0 (0-150) mL. Curative resection (R0) with negative margins was achieved in 19 cases.The median duration of postoperative hospital stay was 9 (5-12) days.
2020 | Year | 07 | Month | 09 | Day |
2020 | Year | 04 | Month | 25 | Day |
Between January 2015 and September 2018, 20 eligible patients were enrolled.
Patients participated this study when their written consent has been obtained.
One case of postoperative leakage and one case of bleeding of grade 2 according to the Clavien-Dindo classification were observed in this series.
No local recurrence was observed in any patient during the median follow-up of 15.0 (12.0-38.0) months.
Completed
2015 | Year | 09 | Month | 24 | Day |
2015 | Year | 09 | Month | 24 | Day |
2015 | Year | 10 | Month | 10 | Day |
2019 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2030 | Year | 03 | Month | 31 | Day |
2015 | Year | 10 | Month | 02 | Day |
2020 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020255
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