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Multi-center randomized controlled study for the effect of different auxiliary traction methods on the efficiency of endoscopic mucosal stripping in esophageal lesions

Multi-center randomized controlled study for the effect of different auxiliary traction methods on the efficiency of endoscopic mucosal stripping in esophageal lesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026917
Enrollment
Unknown
Registered
2019-10-26
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Early esophageal carcinoma and precancerous lesions

Interventions

Group B (dental floss traction group):denta floss traction
Group C (endoloops traction group):endoloops traction
Group A:traditional ESD surgical method

Sponsors

Zhengzhou University First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Before preoperative endoscopic biopsy in January, the pathology was diagnosed as preesophageal carcinoma or early carcinoma: Epithelial(HGIN) or moderate or severe atypical hyperplasia; (2) Preoperative use of white light, iodine staining, enlarged endoscopic narrowband imaging(NBI-ME), endoscopy ultrasound (EUS) and chest CT examination suggested that the lesions were limited to M1, M2, M3 or sm1 and there was no vascular and lymphatic metastasis; (3) The length of the lesion >= 2cm.

Exclusion criteria

Exclusion criteria: (1) There has been lymph node metastasis or distant metastasis; (2) The tumor has invaded the inherent muscle layer; (3) At the same time suffering from serious diseases such as heart, lungs, kidneys, brain, blood and other important organs; (4) There is a serious bleeding tendency (prothrombin time > 14 S or platelet count < 90 x10^9/L. Because cardiovascular and other diseases require long-term anticoagulant drugs, even if the coagulation function is in the normal range before surgery, at least 3 to 7D of the drug should be stopped, and 3 to 7D should be stopped after surgery). (5) Iodine allergy. (6) Negative mucosal lifting. (7) Those who refuse to undergo endoscopic treatment.

Design outcomes

Primary

MeasureTime frame
Total time of ESD surgery;ESD operation time;Disease stripping time;Area of diseased tissue;

Secondary

MeasureTime frame
Total number and time of installation of ancillary equipment;Total and Number of Submucosal Supplements;Traction equipment related complications;Traction equipment related complications;Number of perforations and uncontrolled bleeding during surgery, and the circumstances;Number of sites damaged in deep tissue(different depths) during operation;Number of postoperative complications and their specific situation;

Countries

China

Contacts

Public ContactLiu Bingrong

The First Affiliated Hospital of Zhengzhou University

bingrongliu@qq.com+86 15713815559

Outcome results

None listed

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