Diagnosis and Treatment of Lung Lesions

NCT07642986 | Completed

• 1 other identifier: SirRRSH-2024-RABone
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).

Conditions

Peripheral Pulmonary Nodules; Ablation Techniques

Keywords

Peripheral pulmonary lesions; Tumor ablation; Robotic-assisted bronchoscopy; Single-session procedure

Outcome Measures

Primary Outcomes (3)

• Navigation success rate

  Perioperatively

• Ablation success rate

  Perioperatively

• Post-operative complication rate

  Immediately after the procedure through hospital discharge

Secondary Outcomes (3)

• Diagnostic yield

  Perioperatively

• Postoperative hospital stay

  Immediately after the procedure through hospital discharge

• Local progression-free survival rate

  Three months after the operation

Study Arms (1)

One-stop treatment group

EXPERIMENTAL

Inoperable patients underwent synchronous biopsy and ablation under RAB and cone-beam CT guidance. Following confirmation of atypical cells by rapid on-site evaluation (ROSE), individualized ablation (cryoablation, radiofrequency ablation, or synergistic irreversible electroporation) was performed in the same anesthetic setting.

Procedure: A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)

Interventions

A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) PROCEDURE

Inoperable patients underwent synchronous biopsy and ablation under RAB and cone-beam CT guidance. Following confirmation of atypical cells by rapid on-site evaluation (ROSE), individualized ablation (cryoablation, radiofrequency ablation, or synergistic irreversible electroporation) was performed in the same anesthetic setting.

One-stop treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Have peripheral pulmonary lesions (PPLs).
• Meet at least one of the following conditions: (1) Deemed medically inoperable due to surgical intolerance; (2) Have newly developed or residual nodules after previous lung cancer surgery; (3) Present with multiple bilateral pulmonary nodules; or (4) Explicitly refuse surgical resection.

You may not qualify if:

• Centrally located tumors invading the main bronchi.
• Uncorrectable coagulopathy.
• Evidence of advanced nodal (N2/N3) or distant metastatic disease (unless the PPL represented an oligometastatic lesion targeted with curative intent).

Sponsors & Collaborators

• Jisong Zhang: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Interventions

Coal Tar

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Jisong Zhang, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)