UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033919 |
|---|---|
| Receipt number | R000038677 |
| Scientific Title | Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/03/20 18:10:29 |
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Basic information
Public title
Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract.
Acronym
Clipping, Over-the-scope clip (OTSC) and Stenting Application for a fistula and anastomotic leakage of GI tract.
Scientific Title
Endoscopic Application of Clipping, Over-the-scope clip (OTSC) and Stenting for a fistula and anastomotic leakage of gastro- intestinal tract.
Scientific Title:Acronym
Clipping, Over-the-scope clip (OTSC) and Stenting Application for a fistula and anastomotic leakage of GI tract.
Region
| Japan |
Condition
Condition
Fistula and anastomotic leakage of gastro- intestine after surgery
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to prevent serious infectious state, to shorten hospital inpatient day and cost for medical material and drug
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Leakage or fistula is evaluated by contrast examination on the operation day, third day, a week later and a month later.
Key secondary outcomes
The term of disappearance of leakage, and fistula and cost including hospital charges, a medical care material and drug costs after treatment are calculated. We compare them between this endoscopic treatment and conventional conservative therapy and surgery.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Undergo clipping, over-the-scope clip and tenting for a fistula and anastomotic leakage of gastro- intestine after surgery.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with leakage or fistula after gastrointestinal surgery
Key exclusion criteria
Patients with general condition with pyothorax, panperitonitis and sepsis.
Patients of necessary emergency operation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Makino |
Organization
Nippon Medical School, Tama Nagayama Hospital
Division name
Department of Surgery
Zip code
206-8512
Address
1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512
TEL
0423712111
himiyumo@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Makino |
Organization
Nippon Medical School, Tama Nagayama Hospital
Division name
Department of Surgery
Zip code
206-8512
Address
1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512
TEL
0423712111
Homepage URL
himiyumo@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School,
Tama Nagayama Hospital,
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School,
Tama Nagayama Hospital,
Department of Surgery
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
Nippon Medical School, Tama Nagayama Hospital, Department of Surgery
Address
1-7-1, Nagayama, Tama, Tokyo, Japan, ZIP206-8512
Tel
0423712111
himiyumo@nms.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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038677
