UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034938 |
|---|---|
| Receipt number | R000039829 |
| Scientific Title | Follow-up study of endoscopic necrosectomy for severe acute pancreatitis |
| Date of disclosure of the study information | 2018/11/19 |
| Last modified on | 2019/11/25 18:13:04 |
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Basic information
Public title
Follow-up study of endoscopic necrosectomy for severe acute pancreatitis
Acronym
FSEN
Scientific Title
Follow-up study of endoscopic necrosectomy for severe acute pancreatitis
Scientific Title:Acronym
FSEN
Region
| Japan |
Condition
Condition
acute pancreatitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To declare the efficacy and safety of endoscopic necrosectomy for patients with necrotizing pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of serious complications or death within 6 months of the onset of acute pancreatitis.
Key secondary outcomes
Internal and external secretion failure, bile duct narrowing, treatment times of drainage and necroseectomy, hospital stay and ICU staying period, cost
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Place the tube under the endoscopic ultrasound and drainage the pancreatic necrosis site. If improvement can not be obtained by drainage alone, endoscopic necrosectomy is performed. The necrosectomy is repeated up to 8 times at a frequency of once to twice a week.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a patient with Infectious pancreatic necrosis
A state in which endoscopic treatment is possible
Key exclusion criteria
(1) Cases with bleeding tendency
(2) Case in which insertion of endoscope is difficult
(3) Case in which pancreatic necrosis part can not be visualized by ultrasonic endoscope (EUS)
(4) Patients requiring emergency surgical treatment (gastrointestinal perforation, intestinal necrosis, bleeding which does not respond to medical treatment)
(5) During pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Masamune |
Organization
Tohoku University
Division name
Division of gastroenterology
Zip code
022-717-7171
Address
Sendai city, Aoba-ku, Seiryo-machi 1-1
TEL
022-717-7171
amasamune@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Kume |
Organization
Tohoku University
Division name
Division of gastroenterology
Zip code
022-717-7171
Address
Sendai city, Aoba-ku, Seiryo-machi 1-1
TEL
022-717-7171
Homepage URL
kkume@med.tohoku.ac.jp
Sponsor or person
Institute
Division of gastroenterology, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Division of gastroenterology, Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
Sendai city, Aoba-ku, Seiryo-machi 1-1
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2018 | Year | 11 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039829
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
