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

Ruijin Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Neoplasm Segmentectomy;Intersegmental Plane

Interventions

Iron Sucrose InjectionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Time frame: Up to 90 days post-surgery

Secondary Outcomes

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.

Time frame: Day of surgery

Data from ClinicalTrials.gov

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