Clinical trial · Interventional
Hybrid APC Therapy in Early Central Lung Neoplasms
A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
- 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)
1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms. 1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months follow-up, and after 3 months patients could be continued to follow up. The data are expressed in terms of mean and percentage. The categorical variables are analyzed by chi-square test, and the four table data is analyzed using the exact probability method. The continuous variable analysis is used by t test. Statistical analysis is performed with SPSS 20.0 software. P \< 0.05 is considered statistically significant.
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 |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid APC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hybrid APC Therapy Group
- description
- 1\) Patients are diagnosed as early central lung neoplasms (severe dysplasia, carcinoma in situ, microinvasive carcinoma，mucoepidermoid carcinoma.etc.) by inquiry of the first doctor, CT test, endoscopy and histopathology. Patients who meet inclusion/exclusion criteria are not suitable for or refuse surgery.
- interventionNames
- Procedure: Hybrid APC
Primary outcomes (1)
- measure
- Successful remission rate:
- timeFrame
- 3 months
- description
- successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up
Secondary outcomes (1)
- measure
- Complications
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility. 2. Size ≤ 20 mm 3. Flat, nodule or polypoid type 4. Negative imaging: HRCT indicates no tumor in lung and lymph node enlargement; or PET-CT finds no lesions in lung or suspicious lymph node tumors involve. 5. Clinical stage: Tis or T1N0M0 6. High-grade intraepithelial neoplasia (including severe atypical dysplasia and carcinoma in situ) mucoepidermoid carcinomaand ,squamous cancer and etc. confirmed by biopsy histopathology 7. High-frequency EBUS indicates the depth of lesions is cartilage endomembrane or internal part of adventitia of tracheal membranous part 8. Patients are not suitable for surgery or refuse surgery 9. Inform consent is available Exclusion Criteria: 1. Patients with severe cardiopulmonary dysfunction or other contraindication can not tolerate endoscopic examination and treatment 2. Severe bleeding tendency 3. Poor compliance 4. Unstable vital signs 5. Investigators consider subjects should not be included because of specific situations
References
Publications (0)
Data not yet available