Unique ID issued by UMIN | UMIN000034194 |
---|---|
Receipt number | R000038636 |
Scientific Title | Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2021/03/21 09:12:09 |
Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis
ECO-JAPAN study
Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis
ECO-JAPAN study
Japan |
Type 1 autoimmune pancreatitis (AIP)
Hepato-biliary-pancreatic medicine |
Others
NO
Evaluate the safety and effectiveness of treatment of
obstructive jaundice with corticosteroids alone in definitive AIP without biliary stenting.
Safety,Efficacy
Exploratory
Others
Phase II
The rate of improvement of liver tests after corticosteroid treatment in AIP patients.
1. Steroid-related adverse events (e.g. developed cholangitis or other infectious complications during steroid treatment)
2. Recurrent rate of obstructive jaundice during steroid treatment
3. Steroid-related complications
4. Comparing with control group about the above and medial expense
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
1
Treatment
Other |
without biliary stenting
20 | years-old | <= |
Not applicable |
Male and Female
Patients with suspect of type 1 autoimmune pancreatitis
Agree to consent form
Patients with ECOG performance status 0 or 1
1) Liver dysfunction with viral hepatitis
2) Patients with acute cholangitis
3) Patients with ASA criteria 3, 4, or 5
4) Uncooperative patients
5) Refusal to consent form
100
1st name | Akira |
Middle name | |
Last name | Kurita |
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division of Gastroenterology and Hepatology, Digestive Disease Center
530-8480
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
06-6131-2662
kuritaaki1976@gmail.com
1st name | Akira |
Middle name | |
Last name | Kurita |
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division of Gastroenterology and Hepatology, Digestive Disease Center
530-8480
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
06-6131-2662
kuritaaki1976@gmail.com
Bilio-Pancreatic Stenting study group
None
Self funding
Kitano Hospital, Ethics Committe
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
06-6131-2662
rinshou@kitano-hp.or.jp
NO
大阪医科大学附属病院(大阪府)、関西医科大学附属病院(大阪府)、大阪市立大学医学部附属病院(大阪府)、近畿大学医学部附属病院(大阪府)、北野病院(大阪府)、大阪赤十字病院(大阪府)、天理よろづ相談所病院(奈良県)、神戸大学医学部附属病院(兵庫県)、川崎医科大学附属総合医療センター(岡山県)、福岡大学筑紫病院(福岡県)、宮崎大学医学部附属病院(宮崎県)、熊本大学医学部附属病院(熊本県)、和歌山県立医科大学附属病院(和歌山県)、鹿児島大学医学部附属病院(鹿児島県)、大阪国際がんセンター(大阪府)、鳥取赤十字病院(鳥取県)、北播磨総合医療センター(兵庫県)、島根大学医学部附属病院(島根県)、京都桂病院(京都ふ)、京都府立医科大学附属病院(京都府)、広島赤十字・原爆病院(広島県)、久留米大学医学部附属病院(福岡県)、淀川キリスト教病院(大阪府)、済生会中津病院(大阪府)、香川大学医学部附属病院(香川県)、鳥取大学医学部附属病院(鳥取県)、ベルランド総合病院(大阪府)、大阪大学医学部附属病院(大阪府)、大阪市立総合医療センター(大阪府)、JA尾道総合病院(広島県)、日赤和歌山医療センター(和歌山県)
2018 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 08 | Month | 23 | Day |
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 10 | Month | 01 | Day |
2024 | Year | 12 | Month | 31 | Day |
None
2018 | Year | 09 | Month | 18 | Day |
2021 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038636