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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033919
Receipt No. 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

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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
Email 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
Email himiyumo@nms.ac.jp

Sponsor
Institute Nippon Medical School,

Tama Nagayama Hospital,

Department of Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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