A Review of Surgical Management of Congenital Pulmonary Airway Malformations (CPAM): A Decade of Experience

NCT04449614 | Completed

• 1 other identifier: IRAS 238420
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital pulmonary malformation in children is a rare abnormality mostly diagnosed before birth during antenatal ultrasound examinations. These lesions may expand to form lung cysts in children, cause recurrent lung infections and has a potential for malignant change. Therefore, surgical removal in childhood is favoured as the treatment of choice. The surgical correction may involve 'open' surgery or 'key hole' surgery. There is, however, a variation in surgical and anaesthetic techniques and timing of this surgery and subsequent complications reported post-surgery. The purpose of this investigation is to review anaesthetic and surgical case notes and the subsequent well-being of all children who underwent lung surgery to remove above lung lesions over the last 10 years (2008-2017) at a regional centre. The aim is to look at the current status of these children in relation to their health, growth and development evaluated via a 20-minute structured telephone interview with prior consent.

Conditions

Pulmonary Arteriovenous Malformation; Congenital Disorders

Outcome Measures

Primary Outcomes (2)

• Perioperative morbidity associated with the CPAM removal surgical episode

  This will be a descriptive measure of perioperative complications, namely, number including converted to 'open' surgery from thoracoscopy and its reasons, postoperative respiratory complications needing active therapy such as return to theatre, reintubation, insertion of chest drains to manage pneumothorax, haemothorax or chylothorax, duration of intensive care needed and duration of hospital stay needed.

  28 days postoperative

• Perioperative mortality associated the CPAM removal surgical episode

  This will include 28 day mortality associated with the surgical episode

  28 days postoperative

Secondary Outcomes (2)

• Post surgery long-term well being as reported by parents/guardian

  A prospective 1 year to complete a telephone follow-up of all participant children who had their surgery performed between 2007-2017

• Post surgery long-term development and growth of children as reported by parent/guardian

  A prospective 1 year to complete a telephone follow-up of all participant children who had their surgery performed between 2007-2017

Study Arms (1)

1

Inclusion criteria: All consenting Infants and children who have had A Congenital Pulmonary Airway Malformation (CPAM) surgically removed by thoracoscopy over a 10 year period (2008-2017) in a regional centre. Exclusion criteria: Non consenting participants

Procedure: Thoracoscopic CPAM resection

Interventions

Thoracoscopic CPAM resection PROCEDURE

Surgical removal of lung lesion

1

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants and children who had undergone thoracoscopic surgery for a CPAM from 2008 to 2017 at a regional centre

You may qualify if:

• All children undergoing surgery for a CPAM removal between 2008 - 2017 at a regional hospital.

You may not qualify if:

• Lack of informed consent. Inability to contact parents/guardian for the required post-operative interview

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

Kings College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (10)

• Subramanyam R, Ledbetter K, Fleck R, Mahmoud M. Images in Anesthesiology: Congenital Pulmonary Airway Malformation. Anesthesiology. 2017 Aug;127(2):382. doi: 10.1097/ALN.0000000000001602. No abstract available.

  PMID: 28719530 BACKGROUND

• Cloutier MM, Schaeffer DA, Hight D. Congenital cystic adenomatoid malformation. Chest. 1993 Mar;103(3):761-4. doi: 10.1378/chest.103.3.761.

  PMID: 8449065 BACKGROUND

• Sfakianaki AK, Copel JA. Congenital cystic lesions of the lung: congenital cystic adenomatoid malformation and bronchopulmonary sequestration. Rev Obstet Gynecol. 2012;5(2):85-93.

  PMID: 22866187 BACKGROUND

• Mann S, Wilson RD, Bebbington MW, Adzick NS, Johnson MP. Antenatal diagnosis and management of congenital cystic adenomatoid malformation. Semin Fetal Neonatal Med. 2007 Dec;12(6):477-81. doi: 10.1016/j.siny.2007.06.009. Epub 2007 Oct 22.

  PMID: 17950681 BACKGROUND

• David M, Lamas-Pinheiro R, Henriques-Coelho T. Prenatal and Postnatal Management of Congenital Pulmonary Airway Malformation. Neonatology. 2016;110(2):101-15. doi: 10.1159/000440894. Epub 2016 Apr 13.

  PMID: 27070354 BACKGROUND

• Sueyoshi R, Koga H, Suzuki K, Miyano G, Okawada M, Doi T, Lane GJ, Yamataka A. Surgical intervention for congenital pulmonary airway malformation (CPAM) patients with preoperative pneumonia and abscess formation: "open versus thoracoscopic lobectomy". Pediatr Surg Int. 2016 Apr;32(4):347-51. doi: 10.1007/s00383-015-3848-z. Epub 2015 Dec 12.

  PMID: 26661941 RESULT

• CH'IN KY, TANG MY. Congenital adenomatoid malformation of one lobe of a lung with general anasarca. Arch Pathol (Chic). 1949 Sep;48(3):221-9. No abstract available.

  PMID: 18137795 RESULT

• Laberge JM, Flageole H, Pugash D, Khalife S, Blair G, Filiatrault D, Russo P, Lees G, Wilson RD. Outcome of the prenatally diagnosed congenital cystic adenomatoid lung malformation: a Canadian experience. Fetal Diagn Ther. 2001 May-Jun;16(3):178-86. doi: 10.1159/000053905.

  PMID: 11316935 RESULT

• Kapralik J, Wayne C, Chan E, Nasr A. Surgical versus conservative management of congenital pulmonary airway malformation in children: A systematic review and meta-analysis. J Pediatr Surg. 2016 Mar;51(3):508-12. doi: 10.1016/j.jpedsurg.2015.11.022. Epub 2015 Dec 9.

  PMID: 26775193 RESULT

• Khan H, Kurup M, Saikia S, Desai A, Mathew M, Sheikh A, Goonasekera CDA. Morbidity after thoracoscopic resection of congenital pulmonary airway malformations (CPAM): single center experience over a decade. Pediatr Surg Int. 2021 May;37(5):549-554. doi: 10.1007/s00383-020-04801-1. Epub 2021 Jan 3.

  PMID: 33388955 DERIVED

MeSH Terms

Conditions

Pulmonary Arteriovenous Fistulas; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chulananda Goonasekera

  Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: June 29, 2020
• Study Start: January 10, 2018
• Primary Completion: September 30, 2019
• Study Completion: February 28, 2020
• Last Updated: June 29, 2020

Record last verified: 2018-04

Locations

GB (1)