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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Sucrose injection group | Experimental | The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Sucrose Injection | Drug | The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related grade 3-5 adverse events | 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 | Up to 90 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical margin | 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. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| duration of air leaks | when there is no air leak in the drainage system | 30 days after the patient was discharged. |
| Hospital Costs | The expenses incurred in hospital. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37096093 | Derived | Li C, Zhang X, Feng X, Han D, Xiang J, Li H. A feasible technique for distinguishing the intersegmental plane by transbronchial injection of iron sucrose. JTCVS Tech. 2023 Jan 16;18:137-142. doi: 10.1016/j.xjtc.2022.12.007. eCollection 2023 Apr. |
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The investigators hope the data will available in the end of 2018.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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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.
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| 30 days after the patient was discharged |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |