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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017767
Receipt No. R000020581
Scientific Title Individualized choice of suction method into application cap of over-the-scope clip system: Comparison of simple suction and Twin Grasper assist in a multicenter study
Date of disclosure of the study information 2015/06/22
Last modified on 2016/11/30

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Basic information
Public title Individualized choice of suction method into application cap of over-the-scope clip system: Comparison of simple suction and Twin Grasper assist in a multicenter study
Acronym Suction method of an OTSC system: Comparison of simple suction and Twin Grasper in a multicenter study
Scientific Title Individualized choice of suction method into application cap of over-the-scope clip system: Comparison of simple suction and Twin Grasper assist in a multicenter study
Scientific Title:Acronym Suction method of an OTSC system: Comparison of simple suction and Twin Grasper in a multicenter study
Region
Japan

Condition
Condition GI refractory bleeding and leaks, including perforations, anastomotic leakage, and fistulae
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To suggest a directional strategy for choosing a suction method into application cap of the OTSC system by comparing the clinical data of simple suction to the Twin Grasper (TG) assist in a multicenter study to manage GI refractory bleeding, leaks, and fistulae
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The technical success rate (TSR), clinical success rate (CSR), procedure time, and complication rate
Key secondary outcomes The TSR and CSR regarding each parameter and the indications, location of the defect, maximum defect size and duration since onset (Immediate, Acute, or Chronic), the CSRs between both groups regarding the combined parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 simple suction:one time per one procedure
Interventions/Control_2 Twin Grasper (TG) assist:one time per one procedure
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 We included 56 patients who underwent OTSC placement using Simple Suction or the TG assist due to GI refractory bleeding, leaks, or fistulae.
Key exclusion criteria excluding two cases that used the Anchor
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Kobara
Organization Faculty of Medicine, Kagawa University
Division name Gastroenterology and Neurology
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-891-2156
Email kobara@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuoka
Organization Faculty of Medicine, Kagawa University
Division name Investigator
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-898-5111
Homepage URL
Email chosa@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University Hospital
Institute
Department

Funding Source
Organization Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kochi Health Sciences Center, Sakaide City Hospital, Ehime Rosai Hospital, Kagawa Saiseikai Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 香川済生会病院(香川県)、愛媛労災病院(愛媛県)、高知医療センター(高知県)、坂出市立病院(香川県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 22 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
Aim, To demonstrate the clinical outcomes of a multicenter experience and to suggest guidelines for choosing a suction method. 
Methods, This retrospective study at 5 medical centers involved 58 consecutive patients undergoing OTSC placement. The overall rates of technical success (TSR), clinical success (CSR), complications, and procedure time were analyzed as major outcomes. Subsequently, 56 patients, excluding two cases that used the Anchor device, were divided into two groups: 14 cases of simple suction (SS group) and 42 cases using the Twin Grasper (TG group). Secondary evaluation was performed to clarify the predictors of OTSC success. 
Results, The TSR, CSR, complication rate, and median procedure time were 89.7%, 84.5%, 1.8%, and 8 min, respectively, demonstrating good outcomes. However, significant differences were observed between the two groups in terms of the mean procedure time (5.9 vs. 14.1 min). The CSR of the SS- and TG-groups among cases with a maximum defect size less than 10 mm and immediate or acute refractory bleeding was 100%, which suggests that SS is a better method than TG in terms of time efficacy. The CSR in the SS-group (78.6%), despite the technical success of the SS method (TSR, 100%), tended to decrease due to delayed leakage compared to that in the TG-group (TSR, CSR, 88.1%), indicating that TG may be desirable for leaks and fistulae with defects of the entire layer. 
Conclusion, OTSC system is a safe and effective therapeutic option for GI defects. Individualized selection of the suction method based on particular clinical conditions may contribute to the improvement of OTSC success.
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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 22 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 01 Day
Last modified on
2016 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020581

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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