Lung Neoplasm, Segmentectomy;Intersegmental Plane
Conditions
Brief summary
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.
Detailed description
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.
Interventions
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years ≤age ≤80 years * The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy. * The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.
Exclusion criteria
* A known allergy to Iron Sucrose Injection * The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung. * Patients who have not received segmental resection. * Patients who converted to thoracotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related grade 3-5 adverse events | Up to 90 days post-surgery | Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical margin | Day of surgery | Intraoperative measured by the surgeons.From the tumor peripheral to the lung margin.According to the guidelines,the margins should ≥2cm or ≥ the size of the tumor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| duration of air leaks | 30 days after the patient was discharged. | when there is no air leak in the drainage system |
| Hospital Costs | 30 days after the patient was discharged | The expenses incurred in hospital. |
Countries
China
Outcome results
None listed