Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining

Lung Neoplasm Clinical Trial

Official title:

This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516500
• Other study ID #: RTS-006
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: January 21, 2021

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms
• Segmentectomy;Intersegmental Plane

Intervention

Drug:
• Iron Sucrose Injection
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of air leaks	when there is no air leak in the drainage system	30 days after the patient was discharged.
Other	Hospital Costs	The expenses incurred in hospital.	30 days after the patient was discharged
Primary	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
Secondary	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