UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017767
Receipt number 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 16:56:15

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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 or person

Institute

Kagawa University Hospital

Institute

Department

Personal name



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

Value
https://center6.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