Endoscopic submucosal dissection followed by regional lymph node dissection in the treatment of high-risk superficial esophageal squamous cell carcinoma: a prospective non-randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085595

Enrollment

Unknown

Registered

2024-06-13

Start date

2024-08-01

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Esophageal squamous cell carcinoma

Interventions

Regional lymph node dissection group:Regional lymph node dissection

Esophagectomy group:Esophagectomy

Lymph node preservation group:Radiotherapy/chemotherapy or follow-up

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Additional lymph node dissection group: 1) age =18 years old, < 80 years old; 2) no previous history of esophageal surgery; 3) SESCC was diagnosed by pathology and endoscopy without evidence of lymph node metastasis on preoperative enhanced CT; 4) lesion size =3/4 weeks; 5) en bloc resection; 6) patients refused or could not tolerate radical resection of esophageal cancer; 7) informed consent of patients. Additional radical resection group: 1) age =18 years old, < 80 years old; 2) no previous history of esophageal surgery; 3) SESCC was diagnosed by pathology and endoscopy without evidence of lymph node metastasis on preoperative enhanced CT; 4) lesion size =3/4 weeks; 5) en bloc resection; 6) patients' informed consent. Lymph node preservation group: 1) age =18 years old, < 80 years old; 2) no previous history of esophageal surgery; 3) SESCC was diagnosed by pathology and endoscopy without evidence of lymph node metastasis on preoperative enhanced CT; 4) lesion size =3/4 weeks; 5) en bloc resection; 6) patients refused or could not tolerate radical esophagectomy/lymph node dissection; 7) informed consent of patients.

Exclusion criteria

Exclusion criteria: 1) positive vertical margin; 2) postoperative pathological non-squamous cell carcinoma; 3) postoperative pathological infiltration to the muscular layer; 4) patients with other malignant tumors or serious underlying diseases, Eastern Cooperative Oncology Group (ECOG) score greater than 2; 5) refusal to follow up or loss to follow-up.

Design outcomes

Primary

Measure	Time frame
Survival rate;Mortality rate;Cancer-specific mortality;Recurrence rate;Lymph node metastasis;Pathological data;Operational procedure;Life quality;	—

Secondary

Measure	Time frame
Baseline data;Endoscopic data;Complications;	—

Countries

China

Contacts

Public ContactJinlin-Yang

Department of gastroenterology, West China hospital of Sichuan University

yangjinlin@wchscu.cn+86 189 8060 2058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026