- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516500
Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining
August 29, 2021 updated by: Hecheng Li M.D., Ph.D, Ruijin Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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.
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The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to 90 days post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day of surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of air leaks
Time Frame: 30 days after the patient was discharged.
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when there is no air leak in the drainage system
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30 days after the patient was discharged.
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Hospital Costs
Time Frame: 30 days after the patient was discharged
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The expenses incurred in hospital.
|
30 days after the patient was discharged
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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