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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039583

Enrollment

254

Registered

2020-02-24

Start date

2020-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early colon tumor

Interventions

A:Conventional ESD group B:ESD with countertraction method group

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
ESD procedure time	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactRyoji Ichijima

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

ryoji0331@yahoo.co.jp+81-3-3293-1711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026