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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm; Segmentectomy;Intersegmental Plane
• Intervention / Treatment: Drug: Iron Sucrose Injection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iron Sucrose injection group; The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.	Drug: Iron Sucrose Injection; The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	30 days after the patient was discharged

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2018
• Primary Completion (ACTUAL): January 21, 2021
• Study Completion (ACTUAL): January 21, 2021

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: RTS-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The investigators hope the data will available in the end of 2018.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No