A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)

A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial) - A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024080

Enrollment

240

Registered

2016-09-16

Start date

2016-09-16

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

superficial esophageal cancer

Interventions

A: Conventional ESD group B: countertraction ESD group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma or basal cell carcinoma, or endoscopically diagnosed as cancer based on the Japan esophageal society classification. 2) Tumor size of 20 mm or more. 3) Tumor depth of EP, LPM, MM or SM1. 4) Aged 20 years old or more. 5) ECOG performance status of 0, 1 or 2. 6) Adequate organ functions and all of the following conditions within 56 days at registration must be fulfilled: i) Hb is no less than 9.0 g/dl, ii) Plt is no less than 100,000 /mm3. 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Treatment for gastric lesions the same day. 2) The predicted line of mucosal incision is on the previous esophageal ESD. 3) Stenosis due to the previous esophageal ESD. 4) Status after radiation or surgery for esophageal cancer. 5) Severe psychiatric disease. 6) Infectious disease with systemic therapy indicated. 7) Women during pregnancy or breastfeeding. 8) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 9) Unsuitable patient for clinical trial judged by clinicians' view.

Design outcomes

Primary

Measure	Time frame
ESD procedure time	—

Secondary

Measure	Time frame
ESD procedure time according to the location of the lesion, the circumference, and tumor size; the rate of conversion case from conventional ESD to counter-traction ESD; procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa; damage of specimen caused by counter-traction; en bloc resection rate; complete en bloc resection rate; serious adverse events; factors related to technical difficulty	—

Measure

Time frame

ESD procedure time according to the location of the lesion, the circumference, and tumor size; the rate of conversion case from conventional ESD to counter-traction ESD; procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa; damage of specimen caused by counter-traction; en bloc resection rate; complete en bloc resection rate; serious adverse events; factors related to technical difficulty

—

Countries

Japan

Contacts

Public ContactMasao Yoshida

Shizuoka Cancer Center Division of Endoscopy

ma.yoshida@scchr.jp055-989-5222

Outcome results

None listed

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