Clinical trial NCT02364791: A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures
Official title: A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thoracic Surgery Lung
Post-operative Thoracic Air Leak
Keywords: pulmonary resection
chest tube
segmentectomy
lobectomy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Istituto Clinico Humanitas
name: European Institute of Oncology
name: Regina Elena Cancer Institute
name: Baxter Healthcare Corporation
First posted: 2015-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* High risk of prolonged air leak due to at least one of the following reasons:

  * Preoperative FEV1\<80%
  * DLco \< 80%
  * LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
  * Anticipation of intraoperative adhesions (ie, redo surgery)
  * Previous induction chemotherapy for locally advanced NSCLC
  * Chronic steroid use
  * Pleural mesothelioma
* Candidate to one of the following major thoracic surgical intervention:

  * Decortication
  * Reintervention on the same side of the previous intervention
  * Segmentectomy
  * Lobectomy with incomplete fissures on CT scan
* Written informed consent.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
* Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
* Known hypersensitivity to bovine proteins or brilliant blue (FD\&C Blue No.1)

Primary outcomes:
measure: number of days from time of extubation to time of drainage tube removal
timeFrame: up to 7 days
Secondary outcomes:
measure: number of days to end of air leak
timeFrame: up to 7 days
measure: worst grade toxicity per patient
timeFrame: up to 6 weeks
measure: change in quality of life
timeFrame: baseline, one week, one month
measure: number of days from surgical intervention to patient discharge
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
Study officials:
affiliation: National Cancer Institute, Naples
name: Gaetano Rocco, MD, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: