UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042395
Receipt No. 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 2020/11/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kita335@fmu.ac.jp

Sponsor
Institute Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.