UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010389 |
|---|---|
| Receipt number | R000012156 |
| Scientific Title | Safety of endoscopic papillectomy after a pancreatic stent placement above the pancreatic duct orifice |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/04/04 21:02:45 |
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Basic information
Public title
Safety of endoscopic papillectomy after a pancreatic stent placement above the pancreatic duct orifice
Acronym
Inside pancreatic stenting papillectomy
Scientific Title
Safety of endoscopic papillectomy after a pancreatic stent placement above the pancreatic duct orifice
Scientific Title:Acronym
Inside pancreatic stenting papillectomy
Region
| Japan |
Condition
Condition
Tumors of the major duodenal papilla
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic snare papillectomy after a pancreatic stent placement above the pancreatic duct orifice (inside pancreatic stenting papillectomy).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Technical success rate
Incidence of complications
Key secondary outcomes
Residual tumor rate
Tumor recurrence rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Placement of pancreatic stent and endoscopic papillectomy
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
1) Protruded-type tumors of the major duodenal papilla
2) Lesion confined to the major duodenal papilla without spread into the bile duct or pancreatic duct
3) Patients who provided written informed consent
Key exclusion criteria
1) Distant metastases to other organs and lymph nodes
2) Hemorrhagic tendency in patients receiving oral anticoagulants, those with hepatic cirrhosis with coagulation disorders
3) Possibility of the pregnancy
4) Patients who were judged inappropriate for the entry to this study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Nakahara |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Nakahara |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2013 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2017 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012156
