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

Primary Purpose

Lung Neoplasm, Segmentectomy;Intersegmental Plane

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iron Sucrose Injection
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iron Sucrose injection group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2018
Last Updated
August 29, 2021
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03516500
Brief Title
Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm, Segmentectomy;Intersegmental Plane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron Sucrose injection group
Arm Type
Experimental
Arm Description
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose Injection
Intervention Description
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
Primary Outcome Measure Information:
Title
Incidence of treatment-related grade 3-5 adverse events
Description
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 Outcome Measure Information:
Title
Surgical margin
Description
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
Other Pre-specified Outcome Measures:
Title
duration of air leaks
Description
when there is no air leak in the drainage system
Time Frame
30 days after the patient was discharged.
Title
Hospital Costs
Description
The expenses incurred in hospital.
Time Frame
30 days after the patient was discharged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
The investigators hope the data will available in the end of 2018.

Learn more about this trial

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

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