Skip to content

Comparative analysis of the efficacy of dental floss clip traction endoscopic submucosal dissection and conventional submucosal dissection for early esophageal cancer and precancerous lesions: a multicenter, randomized controlled trial

Comparative analysis of the efficacy of dental floss clip traction endoscopic submucosal dissection and conventional submucosal dissection for early esophageal cancer and precancerous lesions: a multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064444
Enrollment
Unknown
Registered
2022-10-08
Start date
2022-10-09
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Early esophageal cancer and precancerous lesions

Interventions

traditional ESD group:Auxiliary traction
dental floss clip traction endoscopic submucosal dissection (ESD) group:Auxiliary traction

Sponsors

Second People's Hospital of Shandong Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years, no gender limit, who agree to undergo esophageal ESD; 2. Lesion length >=2cm; 3. Preoperative white light, iodine staining, narrow band imaging with magnify endoscopy (NBI+ME) and endoscopy were performed.EUS and chest CT showed that the lesion was confined to M1, M2, M3 or SM1 without vascular or lymphatic metastasis (SM1 layer refers to the upper 1/3 layer of submucosa); 4. Early esophageal cancer or precancerous lesions confirmed by preoperative endoscopic biopsy pathology:low grade intraepithelial neoplasia (LGIN) High grade intraepithelial neoplasia (HGIN) or moderate to severe atypical hyperplasia.

Exclusion criteria

Exclusion criteria: 1. Lymph node metastasis or distant metastasis exists; 2. The tumor has invaded the musculi propria; 3. Severe bleeding tendency (prothrombin time > 14s or platelet count < 90x10^9/L). For patients who need to take anticoagulants for a long time due to cardiovascular problems, the anticoagulants should be stopped for at least 3-7 days before surgery, even if the coagulation function is within the normal range, and then again for 3-7 days); 4. Negative mucosal uplift sign; 5. Patients with iodine allergy; 6. Patients with severe heart, liver and kidney insufficiency, severe neuropathy or mental disease; 7. Pregnant or lactating patients; 8. Refuse endoscopic therapy for those who are considered unsuitable for the physical examination of this project by the researchers.

Design outcomes

Primary

MeasureTime frame
ESD operation time;Disease stripping time;Stripping speed per unit time;Number of postoperative complications and their specific situation;

Countries

China

Contacts

Public ContactWei Zhi
bj-1256@163.com+86 13969156983

Outcome results

None listed

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