Pleurodesis Using Hypertonic Glucose

NCT ID: NCT06293885

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Air Leak From Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

D50

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.

Group Type EXPERIMENTAL

Dextrose 50

Intervention Type DRUG

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

Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard of Care - No Dextrose 50

Intervention Type OTHER

Standard of Care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dextrose 50

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

Intervention Type DRUG

Standard of Care - No Dextrose 50

Standard of Care

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

D50

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mehdi Qiabi

Thoracic Surgeon, Assistant Professor, Western university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Deb Lewis

Role: CONTACT

519-685-8500 ext. 75685

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLUG-II

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PleuraSeal Pivotal Study (US)
NCT00748124 TERMINATED PHASE3
PleuraSeal Post Market Study (Europe)
NCT00704171 COMPLETED PHASE4
Thopaz for PALs Evaluation
NCT07105436 NOT_YET_RECRUITING
Stop Air Leak by Talc or Autologous Blood Patch Therapy
NCT06883188 NOT_YET_RECRUITING PHASE2/PHASE3
PCL (Poly-ε-caprolactone) Mesh Pleurodesis
NCT03227978 UNKNOWN EARLY_PHASE1
PRP in 2ry Spontaneous Pneumothorax
NCT03830645 UNKNOWN PHASE1
CT-guided Lung Biopsy Risk Optimization Method
NCT06340178 NOT_YET_RECRUITING NA