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

NCT03516500 | Completed

• 1 other identifier: RTS-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm; Segmentectomy;Intersegmental Plane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Surgical margin

  Day of surgery

Other Outcomes (2)

• duration of air leaks

  30 days after the patient was discharged.

• Hospital Costs

  30 days after the patient was discharged

Study Arms (1)

Iron Sucrose injection group

EXPERIMENTAL

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

Interventions

Iron Sucrose Injection DRUG

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

Iron Sucrose injection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• Li C, Zhang X, Feng X, Han D, Xiang J, Li H. A feasible technique for distinguishing the intersegmental plane by transbronchial injection of iron sucrose. JTCVS Tech. 2023 Jan 16;18:137-142. doi: 10.1016/j.xjtc.2022.12.007. eCollection 2023 Apr.

  PMID: 37096093 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: May 4, 2018
• Study Start: May 9, 2018
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The investigators hope the data will available in the end of 2018.

Locations

CN (1)