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

Not Applicable

Completed

• Conditions: Segmentectomy;Intersegmental Plane; Lung Neoplasm
• Interventions: Drug: Iron Sucrose Injection

• Registration Number: NCT03516500
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Study Start: 2018-05-09
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-29
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron Sucrose injection group	Iron Sucrose Injection	The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China