NCT06293885

Brief Summary

Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

February 25, 2024

Last Update Submit

March 1, 2024

Conditions

Air Leak From Lung

Keywords

air leak

Outcome Measures

Primary Outcomes (1)

  • Prolonged Air Leak

    Prolonged Air Leak

    5 days postoperatively

Secondary Outcomes (2)

  • Duration of Chest Tubes

    immediately after the surgery

  • Home with Chest Tube

    immediately after the surgery

Study Arms (2)

D50

EXPERIMENTAL

A solution of 50% glucose will be injected into the pleural space on the first and possibly the second day after surgery. The injection will be administered through the chest tube, which is already in place.

Drug: Dextrose 50

Standard of care

ACTIVE COMPARATOR

monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given.

Other: Standard of Care - No Dextrose 50

Interventions

Dextrose 50DRUG

a solution of 50% glucose (D50) will be injected into your pleural space

Also known as: D50
D50
Standard of Care - No Dextrose 50OTHER

Standard of Care

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer
  • Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Central Study Contacts

Deb Lewis

CONTACT

519-685-8500deb.lewis@lhsc.on.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic Surgeon, Assistant Professor, Western university

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 5, 2024

Study Start

March 30, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

CA(1)