Staple-line Reinforcement for Prevention of Pulmonary Air Leakage (SPIRAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00925444
First received: June 19, 2009
Last updated: September 17, 2013
Last verified: January 2009
  Purpose

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).


Condition Intervention Phase
Lung Neoplasms
Pulmonary Surgical Procedures
Surgical Staplers
Tissue Adhesives
Chest Tubes
Device: FOREseal
Device: Stapling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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. [ Time Frame: from T0 to the last day air leak observed ] [ Designated as safety issue: No ]

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 [ Time Frame: withing the first one year after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: June 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOREseal Device: FOREseal
a pair of alginate sleeves for linear cutting staplers used in lung surgery
Other Name: FOREseal
Active Comparator: Stapling Device: Stapling
Stapling alon or associated with sealants
Other Name: Stapling

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925444

Locations
France
Assistance Publique Hopitaux de Paris
Paris, France, 75000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean François REGNARD, PhD Centre Hospitalier Hotel Dieu
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00925444     History of Changes
Other Study ID Numbers: P080204, IDRCB 2008-A01386-49
Study First Received: June 19, 2009
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Absorbable implants
Humans
Alginates
Pneumonectomy/methods
Pneumonectomy/instrumentation
Surgical Stapling
Thoracic surgery
Tissue Adhesives
Prospective studies

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014