A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)

A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial) - A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018266

Enrollment

640

Registered

2015-07-10

Start date

2015-07-21

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

Gastric epithelial neoplasia

Interventions

A: Conventional ESD group B: Dental floss-clip ESD group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014. 2) ESD for one lesion. 3) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer. 4) Aged 20 years old or more. 5) ECOG performance status of 0, 1 or 2. 6) The possibility of stenosis after ESD is low. All of the following conditions must be fulfilled: i) Predicted line of mucosal incision is not on the EG junction. ii) Predicted line of mucosal incision is not on the pylorus. 7) 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. 8) Follow up for 30 days after ESD. 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Impossible to suspend anticoagulant or antiplatelet medications except low-dose aspirin. 2) Infectious disease with systemic therapy indicated. 3) Women during pregnancy or breast-feeding. 4) Severe psychiatric disease. 5) Systemic steroids medication. 6) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 7) Severe respiratory disease requiring continuous oxygen therapy. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes millutus or administration of insulin.

Design outcomes

Primary

Measure	Time frame
ESD procedure time	—

Secondary

Measure	Time frame
ESD procedure time according to the proficiency of the operator (trainee or expert), the location of the lesion, the presence of ulcer findings and tumor size; self completion rate of ESD among beginners; procedure time of hemostasis; times of hemostasis; damage of specimen caused by dental floss-clip traction; en bloc resection rate; complete en bloc resection rate; serious adverse events	—

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