Unique ID issued by UMIN | UMIN000017767 |
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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 |
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
Suction method of an OTSC system: Comparison of simple suction and Twin Grasper in a multicenter study
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
Suction method of an OTSC system: Comparison of simple suction and Twin Grasper in a multicenter study
Japan |
GI refractory bleeding and leaks, including perforations, anastomotic leakage, and fistulae
Medicine in general | Gastroenterology | Gastrointestinal surgery |
Others
NO
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
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The technical success rate (TSR), clinical success rate (CSR), procedure time, and complication rate
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Placebo
2
Treatment
Maneuver |
simple suction:one time per one procedure
Twin Grasper (TG) assist:one time per one procedure
20 | years-old | <= |
Not applicable |
Male and Female
We included 56 patients who underwent OTSC placement using Simple Suction or the TG assist due to GI refractory bleeding, leaks, or fistulae.
excluding two cases that used the Anchor
56
1st name | |
Middle name | |
Last name | Hideki Kobara |
Faculty of Medicine, Kagawa University
Gastroenterology and Neurology
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
087-891-2156
kobara@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuoka |
Faculty of Medicine, Kagawa University
Investigator
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
087-898-5111
chosa@med.kagawa-u.ac.jp
Kagawa University Hospital
Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Self funding
Kochi Health Sciences Center, Sakaide City Hospital, Ehime Rosai Hospital, Kagawa Saiseikai Hospital
NO
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)
2015 | Year | 06 | Month | 22 | Day |
Unpublished
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.
Completed
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 06 | Month | 22 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 05 | Month | 31 | Day |
2016 | Year | 08 | Month | 31 | Day |
2015 | Year | 06 | Month | 01 | Day |
2016 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020581
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