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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925444
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : September 18, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FOREseal Device: FOREseal
a pair of alginate sleeves for linear cutting staplers used in lung surgery
Active Comparator: Stapling Device: Stapling
Stapling alon or associated with sealants

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925444

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


Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00925444     History of Changes
Other Study ID Numbers: P080204
IDRCB 2008-A01386-49
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: January 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Absorbable implants
Surgical Stapling
Thoracic surgery
Tissue Adhesives
Prospective studies

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