UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042395 |
|---|---|
| Receipt number | R000048378 |
| Scientific Title | Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial |
| Date of disclosure of the study information | 2020/11/10 |
| Last modified on | 2023/04/26 17:14:41 |
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Basic information
Public title
Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial
Acronym
Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial
Scientific Title
Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial
Scientific Title:Acronym
Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial
Region
| Japan |
Condition
Condition
High risk patient for post-ERCP pancreatitis (PEP)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify pancratic region (head or body/tail) into which prophylactic pancreatic stent should be inserted for PEP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrance of PEP
Key secondary outcomes
1. The highest pancreatic isozyme of serum amylase within a week after ERCP
2. The comparison of ERCP rlated procedures (EST, Precut of Vater papilla, EPBD, endoscopic stone removal, biliary drainage, IDUS, pancratic investigation, the time of procedure)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Insertion of a prophylactic pancreatic stent up to pancreatic body or tail
Interventions/Control_2
Insertion of a prophylactic pancreatic stent in pancreatic head
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
The cases who were performed ERCP to investigate or treat pancreaticobiliary diseases. The patients has more than one of the below risk factors and are placed ERCP guidewire to main pancreatic duct.
1. Past history of pancreatitis
2. Endoscopic pancreatography
3. Precut of Vater papilla
3. The invasive pancreaticobiliary investigation (brush cytology, biopsy, IDUS, cygology of pancreatic juice, etc...)
4. The biliary metallic stent insertion
Key exclusion criteria
1. Vater papilla that has already performed endoscopic procedures (EST, stenting, EPBD, etc)
2. The imposiblity of endoscopic access to Vater papilla
3. The past history of gastorectomy
4. Pancreas divism
5. Intraductal papillary mucinous neoplasm
6. Theraperutic pancreatic stent insertion
7. Chronic pancreatitis, pancreatic head cancer
8. Postampllectomy
9. Malfusion of pancreaticobiliary ducts
10. Allergies to drugs that are used in ERCP
11. Acute pancreatitis, or serum hyperamylasemia (pancratic isozyme more than 150 IU/L)
12. Not sufficiently sedated
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ohira |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City
TEL
+81-24-547-1111
h-ohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City
TEL
+81-24-547-1111
Homepage URL
kita335@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Fukushima Medical University, School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City
Tel
+81-24-547-1111
rs@fmu.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
| 2020 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048378
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