Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

NCT02449980 | Terminated DMC

• 1 other identifier: H-32402
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of two treatment strategies--delayed versus immediate surgery-- for children with primary spontaneous pneumothorax (collapse of the lung). Currently, both treatment modalities are used and there is no clear evidence that either option is superior. The investigators hypothesize that immediate surgery will have better outcomes with lower recurrence rates than delayed surgery.

Conditions

Pneumothorax

Keywords

Spontaneous Pneumothorax; Video Assisted Thoracoscopic Surgery; Tube Thoracostomy; Pediatric Surgery

Outcome Measures

Primary Outcomes (4)

• Recurrence rate

  The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.

  1 month

• Recurrence rate

  The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.

  3 months

• Recurrence rate

  The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.

  6 months

• Recurrence rate

  12 months

Secondary Outcomes (4)

• Postoperative complications

  30 days

• Hospital Length of stay

  1 month

• Time to return to normal activities

  1 month, 3 months, 6 months, 12 months

• Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department)

  1 month

Study Arms (2)

Primary Surgery Group

ACTIVE COMPARATOR

Patients randomized to the primary surgical intervention group will undergo VATS (video-assisted thoracoscopic surgery), apical blebectomy and mechanical pleurodesis during the initial hospital admission by the admitting staff surgeon. The general principles of the surgical technique consist of a 3-port thoracoscopic approach, stapled blebectomy, apical mechanical pleurodesis, and placement of chest tube . Variations of this technique will be at the discretion of the surgeon.

Procedure: Primary Surgery Group

Initial Non-operative management

ACTIVE COMPARATOR

Those randomized to the control group will be admitted and their chest tube or percutaneous drainage catheter managed according to standard protocol. This consists of a minimum of 48 hours of Pleur-Evac suction and daily chest radiographs. The drainage tube is then placed to water seal when resolution of the pneumothorax is documented by x-ray, as well as absence of an air leak. If there are no clinical or radiographic changes after a water seal period, the chest tube is then removed. A post-removal chest radiograph is obtained and the patient is discharged if clinical and radiographic criteria are met.

Procedure: Initial Non-operative management

Interventions

Primary Surgery Group PROCEDURE

Patients will receive surgical intervention during the initial hospital admission, as previously described, for the spontaneous pneumothorax. Patients will then be admitted postoperatively and monitored until discharge criteria are met

Primary Surgery Group

Initial Non-operative management PROCEDURE

Patients will receive percutaneous drainage or chest tube placement as initial management for spontaneous pneumothorax. This will be followed by an observation period until discharge criteria are met.

Initial Non-operative management

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children ages 5 to 18 with clinical diagnosis of primary spontaneous pneumothorax (symptoms of chest pain and/or shortness of breath and pneumothorax demonstrated on chest radiograph) and no prior history of pneumothorax

You may not qualify if:

• Blunt or penetrating trauma
• Cystic fibrosis
• Pneumonia
• Uncontrolled asthma with hospitalization for exacerbation within previous 30 days
• Congenital cystic adenomatoid malformation or congenital lobar emphysema
• History of previous cardiac or pulmonary surgery

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (17)

• Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. doi: 10.1056/NEJM200003233421207. No abstract available.

  PMID: 10727592 BACKGROUND

• Dotson K, Timm N, Gittelman M. Is spontaneous pneumothorax really a pediatric problem? A national perspective. Pediatr Emerg Care. 2012 Apr;28(4):340-4. doi: 10.1097/PEC.0b013e31824d9a65.

  PMID: 22453728 BACKGROUND

• Robinson PD, Cooper P, Ranganathan SC. Evidence-based management of paediatric primary spontaneous pneumothorax. Paediatr Respir Rev. 2009 Sep;10(3):110-7; quiz 117. doi: 10.1016/j.prrv.2008.12.003. Epub 2009 May 21.

  PMID: 19651381 BACKGROUND

• O'Lone E, Elphick HE, Robinson PJ. Spontaneous pneumothorax in children: when is invasive treatment indicated? Pediatr Pulmonol. 2008 Jan;43(1):41-6. doi: 10.1002/ppul.20734.

  PMID: 18041754 BACKGROUND

• Waller DA, Forty J, Morritt GN. Video-assisted thoracoscopic surgery versus thoracotomy for spontaneous pneumothorax. Ann Thorac Surg. 1994 Aug;58(2):372-6; discussion 376-7. doi: 10.1016/0003-4975(94)92210-1.

  PMID: 8067834 BACKGROUND

• Kim J, Kim K, Shim YM, Chang WI, Park KH, Jun TG, Park PW, Chae H, Lee KS. Video-assisted thoracic surgery as a primary therapy for primary spontaneous pneumothorax. Decision making by the guideline of high-resolution computed tomography. Surg Endosc. 1998 Nov;12(11):1290-3. doi: 10.1007/s004649900842.

  PMID: 9788848 BACKGROUND

• Donahue DM, Wright CD, Viale G, Mathisen DJ. Resection of pulmonary blebs and pleurodesis for spontaneous pneumothorax. Chest. 1993 Dec;104(6):1767-9. doi: 10.1378/chest.104.6.1767.

  PMID: 8252960 BACKGROUND

• Cook CH, Melvin WS, Groner JI, Allen E, King DR. A cost-effective thoracoscopic treatment strategy for pediatric spontaneous pneumothorax. Surg Endosc. 1999 Dec;13(12):1208-10. doi: 10.1007/pl00009622.

  PMID: 10594267 BACKGROUND

• Poenaru D, Yazbeck S, Murphy S. Primary spontaneous pneumothorax in children. J Pediatr Surg. 1994 Sep;29(9):1183-5. doi: 10.1016/0022-3468(94)90795-1.

  PMID: 7807340 BACKGROUND

• Butterworth SA, Blair GK, LeBlanc JG, Skarsgard ED. An open and shut case for early VATS treatment of primary spontaneous pneumothorax in children. Can J Surg. 2007 Jun;50(3):171-4.

  PMID: 17568487 BACKGROUND

• Seguier-Lipszyc E, Elizur A, Klin B, Vaiman M, Lotan G. Management of primary spontaneous pneumothorax in children. Clin Pediatr (Phila). 2011 Sep;50(9):797-802. doi: 10.1177/0009922811404699. Epub 2011 Apr 11.

  PMID: 21482575 BACKGROUND

• Qureshi FG, Sandulache VC, Richardson W, Ergun O, Ford HR, Hackam DJ. Primary vs delayed surgery for spontaneous pneumothorax in children: which is better? J Pediatr Surg. 2005 Jan;40(1):166-9. doi: 10.1016/j.jpedsurg.2004.09.042.

  PMID: 15868579 BACKGROUND

• Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. doi: 10.1378/chest.119.2.590.

  PMID: 11171742 BACKGROUND

• MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.

  PMID: 20696690 BACKGROUND

• Ozcan C, McGahren ED, Rodgers BM. Thoracoscopic treatment of spontaneous pneumothorax in children. J Pediatr Surg. 2003 Oct;38(10):1459-64. doi: 10.1016/s0022-3468(03)00496-2.

  PMID: 14577068 BACKGROUND

• Cardillo G, Facciolo F, Giunti R, Gasparri R, Lopergolo M, Orsetti R, Martelli M. Videothoracoscopic treatment of primary spontaneous pneumothorax: a 6-year experience. Ann Thorac Surg. 2000 Feb;69(2):357-61; discussion 361-2. doi: 10.1016/s0003-4975(99)01299-0.

  PMID: 10735663 BACKGROUND

• Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.

  PMID: 14506122 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Monica E Lopez, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery and Pediatrics

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 21, 2015
• Study Start: May 5, 2017
• Primary Completion: July 26, 2018
• Study Completion: January 31, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

US (1)