Unique ID issued by UMIN | UMIN000036603 |
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Receipt number | R000040517 |
Scientific Title | The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer |
Date of disclosure of the study information | 2019/04/25 |
Last modified on | 2019/04/25 20:42:52 |
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
Japan |
Biliary tract cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy of EUS-FNA for preoperative diagnosis of lymph node metastasis in patients with biliary tract cancer
Efficacy
Exploratory
Pragmatic
Not applicable
Diagnostic accuracy of lymph node metastasis by preoperative EUS-FNA compared with resected specimen
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) Age =or >20
(2) Biliary tract cancer scheduled for radical resection
(3) Providing written informed consent
(1) Distant metastasis
(2) Preoperative chemotherapy or radiation therapy
(3) PT-INR =or >1.5
(4) Platelate count < 50000/m3
(5) ASA =or >3
(6) ECOG-PS=4
(7) Pregnancy
(8) Unsuitable for inclusion at the discretion of the physician
55
1st name | Masaki |
Middle name | |
Last name | Kuwatani |
Hokkaido University Hospital
Division of Endoscopy
060-8648
North 14, West 5, Kita-ku, Sapporo
011-716-1161
mkuwatan@med.hokudai.ac.jp
1st name | Ryo |
Middle name | |
Last name | Sugiura |
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Department of Gastroenterology and Hepatology
060-8638
North 15, West 7, Kita-ku, Sapporo
011-716-1161
rsugiura-hok@umin.ac.jp
Hokkaido University Hospital
None
Self funding
Institutional Review Board of Hokkaido University Hospital
North 14, West 5, Kita-ku, Sapporo
011-706-7636
crjimu@huhp.hokudai.ac.jp
NO
2019 | Year | 04 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 01 | Month | 14 | Day |
2019 | Year | 04 | Month | 24 | Day |
2019 | Year | 04 | Month | 24 | Day |
2023 | Year | 12 | Month | 31 | Day |
1) Patient characteristics: age, gender, Performance status, commorbidity
2) Hematological findings: WBC, Hb, Plt, blood fraction
3) Chemistry: ALP, total billirubin, Alb, AST, ALT, gamma-GT, total protein, LDH, creatinine, BUN, amylase, lipase, CRP
4) Coagulation: PT activity(%), PT-INR
5) Tumor maker: CEA, CA19-9
6) Evaluation of the tumor: imaging (abdominal roentgenogram, CT, MRI, US, EUS)
7) Pathological findings of EUS-FNA specimen
8) Procedure characteristics of EUS-FNA (puncture site, success rate, number of puncture, with or without rapid on-site evaluation)
9) Adverse events of EUS-FNA
10) Details of surgery
11) Pathological findings of surgical specimen
2019 | Year | 04 | Month | 25 | Day |
2019 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040517
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