Unique ID issued by UMIN | UMIN000042396 |
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Receipt number | R000048358 |
Scientific Title | Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial |
Date of disclosure of the study information | 2020/11/10 |
Last modified on | 2023/04/26 17:11:48 |
Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial.
Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Japan |
Autoimmune pancreatitis type 1
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate whether using wet suction teqnique can improve the histological diagnosability of EUS-FNB with franseen needle or not in AIP patients
Safety,Efficacy
The cases who show Level 1 or Level 2 histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP.
1. The cases who show Level 1 histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP.
2. The cases who show each four histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP. These findings are
(1) Lymphoplasmacytic infiltrate without granulocytic infiltration
(2) Obliterative phlebitis
(3) Storiform fibrosis
(4) Abundant (> 10 cells/HPF) IgG4 positive cells
3. Adverse events
4. The cases who are obtained histological specimen
5. Number of punctures
6. The cases whose specimen is sufficient for immunostain
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Diagnosis
Food | Maneuver |
EUS-FNB with wet suction technique
Conventional EUS-FNB without wet suction technique
20 | years-old | <= |
Not applicable |
Male and Female
1. Elevated serum IgG4 (no less thatn 135 mg/dl
2. The cases who show pancreatic swelling by echo, CT, MRI, etc.... and who are thought to be AIP.
1. Elevated serum IgG4 are not observed.
2. The cases who have already been administered steroid and whose IgG4, disease have been already improved.
3. The cases who can't be performed EUS-FNA (difficult to insert scope, bleeding tendency).
4. The cases who can't stop antithrombotic according to the gastroinert endoscopy guideline.
d. The cases who were not sufficiently sedated.
e. The cases who disagree with this RCT.
26
1st name | Hiromasa |
Middle name | |
Last name | Ohira |
Fukushima Medical University, School of Medicine
Gastroenterology
960-1295
1 Hikarigaoka, Fukushima City
+81-24-547-1111
h-ohira@fmu.ac.jp
1st name | Mitsuru |
Middle name | |
Last name | Sugimoto |
Fukushima Medical University, School of Medicine
Department of Gastroenterology
960-1295
1 Hikarigaoka
+81-24-547-1111
kita335@fmu.ac.jp
Fukushima Medical University
Fukushima Medical University
Other
Fukushima Medical University
1 Hikarigaoka
+81-24-547-1825
rs@fmu.ac.jp
NO
2020 | Year | 11 | Month | 10 | Day |
Unpublished
Open public recruiting
2020 | Year | 10 | Month | 22 | Day |
2020 | Year | 10 | Month | 22 | Day |
2020 | Year | 11 | Month | 10 | Day |
2025 | Year | 11 | Month | 10 | Day |
2020 | Year | 11 | Month | 09 | Day |
2023 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048358
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