UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039583
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

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Basic information

Public title

A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor

Acronym

CONNECT-C trial

Scientific Title

A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor

Scientific Title:Acronym

CONNECT-C trial

Region

Japan


Condition

Condition

early colon tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To comfirm the superiority of countertraction ESD to conventional ESD in terms of procedure time for patients with early colon tumor

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

ESD procedure time

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

A:Conventional ESD group

Interventions/Control_2

B:ESD with countertraction method group

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

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

Key exclusion criteria

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.

Target sample size

254


Research contact person

Name of lead principal investigator

1st name Hisatomo
Middle name
Last name Ikehara

Organization

Nihon University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Medicine

Zip code

101-8309

Address

1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan

TEL

+81-3-3293-1711

Email

h.ikehara@gmail.com


Public contact

Name of contact person

1st name Ryoji
Middle name
Last name Ichijima

Organization

Nihon University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Medicine

Zip code

101-8309

Address

1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan

TEL

+81-3-3293-1711

Homepage URL


Email

ryoji0331@yahoo.co.jp


Sponsor or person

Institute

Division of Gastroenterology and Hepatology, Department of Medicine
Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Nihon University Hospital

Address

1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo,Japan

Tel

+81-3-3293-1711

Email

ryoji0331@yahoo.co.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

2020 Year 02 Month 24 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

Completed

Date of protocol fixation

2020 Year 02 Month 13 Day

Date of IRB

2020 Year 02 Month 13 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 24 Day

Last modified on

2023 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name