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A Prospective, Multicenter, Randomized, Single-blind, Controlled Trial Evaluating SSAE and Different Embolic Materials to Reduce Intraoperative Bleeding During Resection of Infectious Chest Diseases

A Prospective, Multicenter, Randomized, Single-blind, Controlled Trial Evaluating SSAE and Different Embolic Materials to Reduce Intraoperative Bleeding During Resection of Infectious Chest Diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105930
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-06-03
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Infectious thoracic diseases

Interventions

PVA :Receive PVA particle embolization combined with surgical operation of the internal artery
embolic microspheres :Receive embolic microspheres embolization combined with surgical operation of the internal artery
PVA +embolic microspheres :Receive PVA particle and embolic microspheres embolization combined with surgical operation of the internal artery

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Laboratory and imaging examinations have confirmed the diagnosis of chest infectious diseases, including tuberculous destructive lung, chronic empyema, pulmonary fungal infection, chronic lung abscess, and bronchiectasis with infection, etc. 2.Patients with thoracic infectious diseases: Tuberculous destructive lung lesions involving a single or multiple lung lobes, chronic empyema, pulmonary fungal infection, chronic lung abscess, and bronchiectasis with infection. Two senior chest imaging physicians completed the diagnosis blindly. In case of disagreement, the third senior chest imaging physician made the final decision. 3.Patients who can undergo surgical treatment including lobectomy, combined lobectomy or pneumonectomy, as well as empyema pleurodesis surgery for treatment 4.Age: >= 18 years old, = 1.5 x 10^9/L, platelets>= 100 x 10^9/L, hemoglobin >= 90 g/L. International normalized ratio (INR) or prothrombin time (PT) =3 months. 9.informed consent obtained, with good compliance and willingness to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with combined malignant tumors; 2. Those who have had a history of thoracic surgery in the past; 3. Those who have not received standard anti-infection treatment (including anti-tuberculosis, aspergillus, etc.); 4. Patients with major diseases involving the heart, kidneys, liver, bone marrow or central nervous system; 5. Patients with uncontrollable asthma, heart failure, idiopathic pulmonary fibrosis, etc.; 6. Pregnant or lactating women; 7. Patients judged by the researcher to be unsuitable for SSAE due to clinical conditions ( for arterial puncture); 8. Uncontrollable hyperthyroidism; 9. Those who are severely allergic to iodine contrast agents; 10. Patients whose condition, as judged by the researcher, poses a serious threat to patient safety or affects their ability to complete the study; 11. Patients currently participating in or participating in other clinical trials within 4 weeks before the surgery. twelve Patients with mental disorders or a history of abuse of psychotropic drugs.

Design outcomes

Primary

MeasureTime frame
bleeding volume during operation;

Secondary

MeasureTime frame
Surgical operation time;Separation time of pleural adhesions;The situation of conversion to thoracotomy during total thoracoscopic surgery;Postoperative thoracic drainage volume, time of thoracic tube extraction, and pulmonary leakage;The incidence of bleeding events within one week and one month after the operation;The infection rate occurred during the perioperative period;Pulmonary function before and after the operation;

Countries

China

Contacts

Public ContactSen Jiang

Shanghai Pulmonary Hospital

jasfly77@vip.163.com+86 138 1881 5584

Outcome results

None listed

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