Unique ID issued by UMIN | UMIN000039583 |
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Receipt number | R000045123 |
Scientific Title | A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor |
Date of disclosure of the study information | 2020/02/24 |
Last modified on | 2023/02/26 15:33:00 |
A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor
CONNECT-C trial
A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor
CONNECT-C trial
Japan |
early colon tumor
Gastroenterology |
Malignancy
NO
To comfirm the superiority of countertraction ESD to conventional ESD in terms of procedure time for patients with early colon tumor
Safety,Efficacy
Confirmatory
Phase III
ESD procedure time
1,2,3)ESD procedure time according to the location of the lesion, Macroscopic type, traction type
4) the rate of conversion case from conventional ESD to counter-traction ESD
5,6,7) procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa
8)damage of specimen caused by counter-traction
9)en bloc resection rate
10)complete en bloc resection rate
11) serious adverse events
12) the rate of snaring or Hybrid ESD due to difficulty of ESD
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Device,equipment |
A:Conventional ESD group
B:ESD with countertraction method group
20 | years-old | <= |
Not applicable |
Male and Female
1) preoperative endoscopic diagnosis is colon cancer
2) preorerative endoscopic diagnosis of tumor size is 20 mm or more.
3)preorerative endoscopic diagnosis of tumor size isTumor depth of Tis(M)~T1a(SM1)
4)Aged 20 years old or more.
5)ECOG performance status of 0,1or2
6)Written informed consent
1) Past history of colorectomy
2) lesion on preoperative scar (EMR or ESD)
3)Familial adenomatous polyposis
4) Inflamatory bowel disease
5)Infectious disease with systemic therapy indicated.
6) Patints have difficulty taking bowel preparation
7) Women during pregnancy or breast-feeding
8) Patients with serious comorbidities
9)Patients who did not agree to participate in this clinical trial
10)Unsuitable patient for clinical trial judged by clinicians' view.
254
1st name | Hisatomo |
Middle name | |
Last name | Ikehara |
Nihon University School of Medicine
Division of Gastroenterology and Hepatology, Department of Medicine
101-8309
1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan
+81-3-3293-1711
h.ikehara@gmail.com
1st name | Ryoji |
Middle name | |
Last name | Ichijima |
Nihon University School of Medicine
Division of Gastroenterology and Hepatology, Department of Medicine
101-8309
1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan
+81-3-3293-1711
ryoji0331@yahoo.co.jp
Division of Gastroenterology and Hepatology, Department of Medicine
Nihon University School of Medicine
none
Self funding
Nihon University Hospital
1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan
+81-3-3293-1711
ryoji0331@yahoo.co.jp
NO
2020 | Year | 02 | Month | 24 | Day |
Unpublished
Completed
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2020 | Year | 02 | Month | 24 | Day |
2023 | Year | 02 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045123
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