Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax

NCT01848860 | Unknown Phase 2 DMC

• 1 other identifier: 201211051DIC
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or persisted air leakage. In recent years, thoracoscopic bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax and prolonged air leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a novel method using coverage of the endoscopic suture line by a large absorbable mesh during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the investigators are conducting a prospective randomized trial in National Taiwan University Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to compare the rate of pneumothorax recurrence within one year between the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term pulmonary function between the two groups.

Conditions

Spontaneous Pneumothorax; Surgery

Keywords

Pneumothorax; thoracoscopy; mesh; pleurodesis; treatment

Outcome Measures

Primary Outcomes (1)

• the rates of ipsilateral pneumothorax recurrence

  The detection of pneumothorax recurrence will be performed by chest radiography

  12 months

Secondary Outcomes (2)

• Safety of mesh coverage

  30 days

• long-term safety of mesh coverage

  12 months

Study Arms (2)

Control group

SHAM COMPARATOR

In this group, only thoracoscopic bullectomy and pleural abrasion will be done.

Procedure: Thoracoscopic bullectomy and pleural abrasion

Mesh group

EXPERIMENTAL

In this group, absorbable mesh coverage of the staple line will be performed after thoracoscopic bullectomy and pleural abrasion.

Procedure: Thoracoscopic bullectomy and pleural abrasion; Biological: Mesh coverage of the staple line

Interventions

Thoracoscopic bullectomy and pleural abrasion PROCEDURE

Thoracoscopic bullectomy and pleural abrasion will be performed in a standard fashion under general anesthesia using intubated one-lung ventilation. When blebs are identified, they will be grasped with the ring forceps and excised with an endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. Thoracoscopic pleural abrasion will be performed at the parietal pleura above the 5th intercostal space by inserting the dissector with a strip of diathermy scratch pad through the port sites in all patients.

Control group; Mesh group

Mesh coverage of the staple line BIOLOGICAL

Absorbable mesh coverage of the staple line will be performed in the mesh group after thoracoscopic bullectomy in the mesh group

Mesh group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15 and 50 years old.
• Spontaneous pneumothorax requiring thoracoscopic surgery.
• With written inform consent

You may not qualify if:

• With underlying pulmonary disease (chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, etc)
• A history of previous ipsilateral thoracic operation
• Diagnosis of catamenial pneumothorax
• Diagnosis of lymphangioleiomyomatosis
• Concurrent hemopneumothorax with bleeding \> 500ml/h
• Pregnant or lactating women
• Other serious concomitant illness or medical conditions:
• Congestive heart failure or unstable angina pectoris.
• History of myocardial infarction within 1 year prior to the study entry.
• Uncontrolled hypertension or arrhythmia.
• History of significant neurologic or psychiatric disorders, including dementia or seizure.
• Active infection requiring i.v. antibiotics.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (1)

• Hsu HH, Liu YH, Chen HY, Chen PH, Chen KC, Hsieh MJ, Lin MW, Kuo SW, Huang PM, Chao YK, Wu CF, Wu CY, Chiu CH, Chen WH, Wen CT, Liu CY, Wu YC, Chen JS. Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax. Ann Thorac Surg. 2021 Nov;112(5):1609-1615. doi: 10.1016/j.athoracsur.2020.11.012. Epub 2021 May 1.

  PMID: 33279544 DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jin-Shing Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Shing Chen, MD, PhD

CONTACT

886-972651421; chenjs@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

TW (1)