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Completed

NCT Number: NCT03516500

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron Sucrose Injection

Drug

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

Primary outcomes

  1. Incidence of treatment-related grade 3-5 adverse events

    Time frame: 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 outcomes

  1. Surgical margin

    Time frame: 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 outcomes

  1. duration of air leaks

    Time frame: 30 days after the patient was discharged.

    when there is no air leak in the drainage system

  2. Hospital Costs

    Time frame: 30 days after the patient was discharged

    The expenses incurred in hospital.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 4, 2018
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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