UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053314 |
|---|---|
| Receipt number | R000060840 |
| Scientific Title | Serum trypsin as an early predictor of post-endoscopic retrograde pancreatography pancreatitis |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/10 19:05:54 |
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Basic information
Public title
Serum trypsin as an early predictor of post-endoscopic retrograde pancreatography pancreatitis
Acronym
Serum trypsin as an early predictor of post-endoscopic retrograde pancreatography pancreatitis
Scientific Title
Serum trypsin as an early predictor of post-endoscopic retrograde pancreatography pancreatitis
Scientific Title:Acronym
Serum trypsin as an early predictor of post-endoscopic retrograde pancreatography pancreatitis
Region
| Japan |
Condition
Condition
patients who wil be plaining to undergo ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was performed to clarify the ability of serum trypsin measured immediately after ERCP to predict early-stage PEP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the diagnostic ability of serum of tripsin levels immediately after (0h-TRY) and 2 hours after (2h-TRY) ERCP to predict PEP.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
they were aged over 20 years and
they had intact papilla, defined as the absence of previous sphincterotomy, papillary balloon dilation, or pancreaticobiliary stenting.
Key exclusion criteria
they had acute pancreatitis, defined as two of the following three features: (1) abdominal pain consistent with acute pancreatitis (acute onset of persistent, severe, epigastric pain often radiating to the back); (2) pancreatic enzyme activity at least the upper limit of normal; and (3) characteristic findings of acute pancreatitis on computed tomography(CT), magnetic resonance imaging or transabdominal ultrasound
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | masayuki |
| Middle name | |
| Last name | kitano |
Organization
Wakayama Medical University
Division name
Second Departmet of Internal Medicine
Zip code
6418509
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
0734472300
ttakashi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tamura |
Organization
Wakayama Medical University
Division name
Second Departmet of Internal Medicine
Zip code
6418509
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
0734472300
Homepage URL
ttakashi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Bekelit Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review boards of wakayama medical university
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://nx.ct-portal.com/shinseis/detail_files?id=404031
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
147
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060840
