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The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

Phase 2
18 Years
80 Years
Not Enrolling
Pleural Effusion, Pleural Effusion Malignant

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Trial Information

The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

In this study the investigators will attempt to reduce the degree of inflammation (and thus
polymorphonuclear leukocyte counts) in the pleural space following a lung resection
procedure by administering the Non Steroid Anti-Inflammatory Drug (NSAID) Naproxen in tandem
with Proton Pump Inhibitor (PPI) Pantoprazole, ideally leading towards a significantly
reduced volume of transudate and exudate generated.

This will be achieved by running a placebo-controlled double blinded randomized control
trial where investigators and participants will be blinded so as to eliminate experimenter
bias. After screening for suitable participants using stringent inclusion and exclusion
criteria, patients will be administered by allied health professionals 500mg Naproxen BID
and 40mg Pantoprazole QD, or an identical placebo for four weeks following resection
surgery. Patients will undergo a thorough examination during their scheduled follow-up
appointments to monitor general vitals as well as possible gastrointestinal complications.
The primary outcome is a significant reduction (Δ100ml) of chest fluid extracted in the
intervention arm of the study in comparison to that of the control arm. Secondary outcomes
will include a reduction in length of stay measured in days between control and intervention
arms as well as a reduction in the total number of days chest tubes are retained in-situ.
Conditions such as mortality and morbidity, the onset of complications, and general
re-admission rates will also be recorded.

Inclusion Criteria:

- Participants must be between 18 and 80 years of age

- Participants must be undergoing a major lung resection due to primary or secondary

- Must have an aptitude for following directions and commitment to the study

Exclusion Criteria:

- Patients who are unable to read and communicate in English

- Patients undergoing a pneumonectomy or VATS lung resection

- Previous treatments on the same anatomical side including chemotherapy, radiation
therapy, and radio-frequency ablation

- Patients who have undergone decortication for empyema or malignancy.

- Patients who have a chest tube in-situ for persistent air leak

- Patients with clinical or laboratory indicators of renal failure, defined as serum
creatinine level of 170µmol/l

- Patients with active or previous history of peptic ulcer disease

- Patients with a known intolerance to Proton Pump Inhibitors (PPIs)

- Known allergy to study drugs

- Use of NSAIDs 4 weeks prior to randomization or on-going use of NSAIDs.

- The use of any medications known to reduce inflammation, including but not limited
to: steroids (both oral and intravenously), methotrexate, COX-II inhibitors, other

- Chest tube for persistent air leak.

- Patients who are pregnant or lactating

- Current drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.

- Inability or unwillingness of individual or legal guardian/representative to give
written informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in volume of pleural effusion collected

Outcome Description:

The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Yaron Shargall, MD, BSc, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University


Canada: Health Canada

Study ID:




Start Date:

January 2013

Completion Date:

February 2014

Related Keywords:

  • Pleural Effusion
  • Pleural Effusion Malignant
  • Chest tubes
  • Length of stay
  • Pleural effusion
  • Lung resection
  • Post-operative
  • Lung cancer
  • Pleural Effusion
  • Pleural Effusion, Malignant