Lung NeoplasmsPhase 4SPIRALNCT00925444

Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

A Phase 4 study testing FOREseal and Stapling in people with Lung Neoplasms and Pulmonary Surgical Procedures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers
What is being tested?: FOREseal and Stapling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 1 siteFrance
Study dates: Jun 2009to Mar 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Assistance Publique Hopitaux de Paris
Paris, 75000

Other trials in France

About this study

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.

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).

Read the 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.

Conditions: Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers, Tissue Adhesives, Chest Tubes
Being tested: FOREseal, Stapling
Keywords: Absorbable implants, Humans, Alginates, Pneumonectomy/methods, Pneumonectomy/instrumentation, Surgical Stapling, Thoracic surgery, Tissue Adhesives, Prospective studies
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOREsealDevice
a pair of alginate sleeves for linear cutting staplers used in lung surgery
StaplingDevice
Stapling alon or associated with sealants

Study groups in NCT00925444
Study group	Role	What they receive
FOREseal	Experimental	Not described Receives: Device: FOREseal
Stapling	Active comparator	Not described Receives: Device: Stapling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: from T0 to the last day air leak observed

Secondary outcomes (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
Measured: withing the first one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Mar 2013

First posted22 Jun 2009 (estimated)
Study startJun 2009
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00925444
Sponsor's protocol ID: P080204
Other IDs: IDRCB 2008-A01386-49
Acronym: SPIRAL
Status last verified: Jan 2009
First submitted: 19 Jun 2009
Last updated: 18 Sep 2013
Results posted: No
Data monitoring committee: No

Publications

Fleisher AG, Evans KG, Nelems B, Finley RJ. Effect of routine fibrin glue use on the duration of air leaks after lobectomy. Ann Thorac Surg. 1990 Jan;49(1):133-4. doi: 10.1016/0003-4975(90)90371-c.
PubMed 2297261
Macchiarini P, Wain J, Almy S, Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg. 1999 Apr;117(4):751-8. doi: 10.1016/S0022-5223(99)70296-5.
PubMed 10096971
Porte HL, Jany T, Akkad R, Conti M, Gillet PA, Guidat A, Wurtz AJ. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg. 2001 May;71(5):1618-22. doi: 10.1016/s0003-4975(01)02468-7.
PubMed 11383810
Wain JC, Kaiser LR, Johnstone DW, Yang SC, Wright CD, Friedberg JS, Feins RH, Heitmiller RF, Mathisen DJ, Selwyn MR. Trial of a novel synthetic sealant in preventing air leaks after lung resection. Ann Thorac Surg. 2001 May;71(5):1623-8; discussion 1628-9. doi: 10.1016/s0003-4975(01)02537-1.
PubMed 11383811
Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Ann Thorac Surg. 2003 May;75(5):1587-92. doi: 10.1016/s0003-4975(02)04994-9.
PubMed 12735583
Thomas P, Massard G, Porte H, Doddoli C, Ducrocq X, Conti M. A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal): report of a three-center phase II clinical trial. Eur J Cardiothorac Surg. 2006 Jun;29(6):880-5. doi: 10.1016/j.ejcts.2006.01.067. Epub 2006 May 3.
PubMed 16675257
Abolhoda A, Liu D, Brooks A, Burt M. Prolonged air leak following radical upper lobectomy: an analysis of incidence and possible risk factors. Chest. 1998 Jun;113(6):1507-10. doi: 10.1378/chest.113.6.1507.
PubMed 9631785
Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263.
PubMed 11083673
Varela G, Jimenez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):329-33. doi: 10.1016/j.ejcts.2004.11.005.
PubMed 15691691
Mouritzen C, Dromer M, Keinecke HO. The effect of fibrin glueing to seal bronchial and alveolar leakages after pulmonary resections and decortications. Eur J Cardiothorac Surg. 1993;7(2):75-80. doi: 10.1016/1010-7940(93)90184-d.
PubMed 8442983
Wong K, Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg. 1997 Oct;64(4):979-81. doi: 10.1016/s0003-4975(97)00820-5.
PubMed 9354513
Tansley P, Al-Mulhim F, Lim E, Ladas G, Goldstraw P. A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks. J Thorac Cardiovasc Surg. 2006 Jul;132(1):105-12. doi: 10.1016/j.jtcvs.2006.02.022.
PubMed 16798309
Rami R, Mateu M. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev. 2001;(4):CD003051. doi: 10.1002/14651858.CD003051.
PubMed 11687173
Belboul A, Dernevik L, Aljassim O, Skrbic B, Radberg G, Roberts D. The effect of autologous fibrin sealant (Vivostat) on morbidity after pulmonary lobectomy: a prospective randomised, blinded study. Eur J Cardiothorac Surg. 2004 Dec;26(6):1187-91. doi: 10.1016/j.ejcts.2004.08.009.
PubMed 15541982

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00925444
Acronym / sponsor ID: SPIRAL / P080204
Conditions: 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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 380 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: Jun 2009
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 22 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FOREseal	Experimental	Device: FOREseal
Stapling	Active comparator	Device: Stapling

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FOREseala pair of alginate sleeves for linear cutting staplers used in lung surgery	Device	FOREseal
StaplingStapling alon or associated with sealants	Device	Stapling

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Background: PubMed 2297261Fleisher AG, Evans KG, Nelems B, Finley RJ. Effect of routine fibrin glue use on the duration of air leaks after lobectomy. Ann Thorac Surg. 1990 Jan;49(1):133-4. doi: 10.1016/0003-4975(90)90371-c.
Background: PubMed 10096971Macchiarini P, Wain J, Almy S, Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg. 1999 Apr;117(4):751-8. doi: 10.1016/S0022-5223(99)70296-5.
Background: PubMed 11383810Porte HL, Jany T, Akkad R, Conti M, Gillet PA, Guidat A, Wurtz AJ. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg. 2001 May;71(5):1618-22. doi: 10.1016/s0003-4975(01)02468-7.
Background: PubMed 11383811Wain JC, Kaiser LR, Johnstone DW, Yang SC, Wright CD, Friedberg JS, Feins RH, Heitmiller RF, Mathisen DJ, Selwyn MR. Trial of a novel synthetic sealant in preventing air leaks after lung resection. Ann Thorac Surg. 2001 May;71(5):1623-8; discussion 1628-9. doi: 10.1016/s0003-4975(01)02537-1.
Background: PubMed 12735583Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Ann Thorac Surg. 2003 May;75(5):1587-92. doi: 10.1016/s0003-4975(02)04994-9.
Background: PubMed 16675257Thomas P, Massard G, Porte H, Doddoli C, Ducrocq X, Conti M. A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal): report of a three-center phase II clinical trial. Eur J Cardiothorac Surg. 2006 Jun;29(6):880-5. doi: 10.1016/j.ejcts.2006.01.067. Epub 2006 May 3.
Background: PubMed 9631785Abolhoda A, Liu D, Brooks A, Burt M. Prolonged air leak following radical upper lobectomy: an analysis of incidence and possible risk factors. Chest. 1998 Jun;113(6):1507-10. doi: 10.1378/chest.113.6.1507.
Background: PubMed 11083673Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263.
Background: PubMed 15691691Varela G, Jimenez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):329-33. doi: 10.1016/j.ejcts.2004.11.005.
Background: PubMed 8442983Mouritzen C, Dromer M, Keinecke HO. The effect of fibrin glueing to seal bronchial and alveolar leakages after pulmonary resections and decortications. Eur J Cardiothorac Surg. 1993;7(2):75-80. doi: 10.1016/1010-7940(93)90184-d.
Background: PubMed 9354513Wong K, Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg. 1997 Oct;64(4):979-81. doi: 10.1016/s0003-4975(97)00820-5.
Background: PubMed 16798309Tansley P, Al-Mulhim F, Lim E, Ladas G, Goldstraw P. A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks. J Thorac Cardiovasc Surg. 2006 Jul;132(1):105-12. doi: 10.1016/j.jtcvs.2006.02.022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean François REGNARD, PhD principal investigator

Centre Hospitalier Hotel Dieu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FOREseal and Stapling in people with Lung Neoplasms and Pulmonary Surgical Procedures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925444, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.