Clinical trial · Interventional
Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma
Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study
NCT03404921CI-TRIAL-00039534completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Superficial Mucosal Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD | Procedure | — | UNRESOLVED |
| ESTD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ESTD group
- description
- Use tunnelling method during ESD operation
- interventionNames
- Procedure: ESTD
- type
- OTHER
- label
- ESD group
- description
- Use traditional method during ESD operation
- interventionNames
- Procedure: ESD
Primary outcomes (1)
- measure
- The procedure time
- timeFrame
- day 1
- description
- Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years; * Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications; * Suspected localized mucosal lesions detected by endoscopy. Exclusion Criteria: * Malignancy or other advanced disease with a life expectancy of \< 6 months as judged by the investigator. * The ASA classification of physical status ≥ 4 as judged by the investigator. * Severe hepatic disease or renal disease * Ability to understand and the willingness to sign a written informed consent document. * Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. * Haemorrhagic disorder. * Patients who had a history of esophagectomy or a recurrent lesion. * Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine. * Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. * Known or suspected alcohol, drug or medication abuse. * Any condition associated with poor compliance as judged by the investigator. * Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. * Involvement in the planning and conduct of the study. Previous enrollment in the present study
References
Publications (1)
- DERIVEDFan X, Wu Q, Li R, Chen W, Xie H, Zhao X, Zhu S, Fan C, Li J, Liu M, Liu Z, Han Y. Clinical benefit of tunnel endoscopic submucosal dissection for esophageal squamous cancer: a multicenter, randomized controlled trial. Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22. PMID 35461890