Back to resultsStaple-line Reinforcement for Prevention of Pulmonary Air Leakage (SPIRAL)
Primary Purpose
Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
FOREseal
Stapling
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Absorbable implants, Humans, Alginates, Pneumonectomy/methods, Pneumonectomy/instrumentation, Surgical Stapling, Thoracic surgery, Tissue Adhesives, Prospective studies
Eligibility Criteria
Inclusion Criteria:
- Patient 18 years old or over.
- Patient that undergoes a lobectomy or bilobectomy for lung cancer,
- Patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling.
- Patient that has signed the informed consent before the operation.
- Patient that benefits from a social security regime.
Exclusion Criteria:
- Patient with history of thoracotomy on the side operated on.
- Patient with severe pleural infection and/or infection of parenchyma.
- Presence of air leakage after liberation of lung in cases of pleural symphysis.
- Patient pregnant, giving birth or nursing.
- Patient presenting a contra indication to the aerostatic products used.
- Patient already participating in biomedical research.
Sites / Locations
- Assistance Publique Hopitaux de Paris
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOREseal
Stapling
Arm Description
Outcomes
Primary Outcome Measures
Air leak (presence or absence of bubbles) will be assessed from T0: one hour after extubation, and then twice daily (morning and evening). The mean duration of post-operative air leakage will be calculated from T0 to the last day air leak observed.
Secondary Outcome Measures
Incidence of patients presenting prolonged air leakage (lasting more than 5 days). Average duration of drainage Incidence of patients without any air leakage at 24 hours after surgery Post-operative complications Nature and costs of treatments
Full Information
NCT ID
NCT00925444
First Posted
June 19, 2009
Last Updated
September 17, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00925444
Brief Title
Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
Acronym
SPIRAL
Official Title
Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer.
Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).
Detailed Description
Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung.
FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification.
Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants.
This is a multi centre, prospective controlled and randomised clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers, Tissue Adhesives, Chest Tubes
Keywords
Absorbable implants, Humans, Alginates, Pneumonectomy/methods, Pneumonectomy/instrumentation, Surgical Stapling, Thoracic surgery, Tissue Adhesives, Prospective studies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOREseal
Arm Type
Experimental
Arm Title
Stapling
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
FOREseal
Intervention Description
a pair of alginate sleeves for linear cutting staplers used in lung surgery
Intervention Type
Device
Intervention Name(s)
Stapling
Intervention Description
Stapling alon or associated with sealants
Primary Outcome Measure Information:
Title
Air leak (presence or absence of bubbles) will be assessed from T0: one hour after extubation, and then twice daily (morning and evening). The mean duration of post-operative air leakage will be calculated from T0 to the last day air leak observed.
Time Frame
from T0 to the last day air leak observed
Secondary Outcome Measure Information:
Title
Incidence of patients presenting prolonged air leakage (lasting more than 5 days). Average duration of drainage Incidence of patients without any air leakage at 24 hours after surgery Post-operative complications Nature and costs of treatments
Time Frame
withing the first one year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient 18 years old or over.
Patient that undergoes a lobectomy or bilobectomy for lung cancer,
Patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling.
Patient that has signed the informed consent before the operation.
Patient that benefits from a social security regime.
Exclusion Criteria:
Patient with history of thoracotomy on the side operated on.
Patient with severe pleural infection and/or infection of parenchyma.
Presence of air leakage after liberation of lung in cases of pleural symphysis.
Patient pregnant, giving birth or nursing.
Patient presenting a contra indication to the aerostatic products used.
Patient already participating in biomedical research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean François REGNARD, PhD
Organizational Affiliation
Centre Hospitalier Hotel Dieu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Paris
City
Paris
ZIP/Postal Code
75000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
2297261
Citation
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PubMed Identifier
11383810
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PubMed Identifier
11383811
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PubMed Identifier
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Citation
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Citation
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Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
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