The iTOF study pilot

• Research type

  Research Study

• Full title

  Indocyanine green (ICG) and near infrared fluorescence (NIRF) guided assessment of the bowel and oesophageal anastomosis during repair of oesophageal atresia with distal trachea-oesophageal fistula (OA/dTOF): a cohort pilot study

• IRAS ID

  302896

• Contact name

  Max Pachl

• Contact email

  max.pachl@nhs.net

• Sponsor organisation

  Birmingham Children's Hospital

• Clinicaltrials.gov Identifier

  NCT05735964

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  Oesophageal atresia (OA) is the most common congenital anomaly of the oesophagus (gullet). There is interruption of the continuity of the oesophagus, with or without an abnormal communication with the trachea (windpipe) called a tracheo-oesophageal fistula (TOF). Once incompatible with life, it is now a congenital anomaly with overall survival rates > 90%. This reflects significant developments in surgical techniques and in neonatal care since the 1940s.
  All children with OA and/or TOF need surgical repair to restore continuity of the oesophagus allowing them to eat and drink normally.
  Only types C and D have a connection (fistula) from the distal (lower) end of the oesophagus to the trachea called a distal tracheo-oesophageal fistula (dTOF).
  Initial management of any baby with suspected oesophageal atresia involves placing a replogle tube to drain saliva from the upper blind ending oesophageal pouch and prevent overspill into the lungs. This is usually removed during surgery.
  Surgical repair involves dissecting the fistula off the trachea and closing the resulting defect. The fistula is then joined to the upper atretic oesophageal pouch to create an oesophagus which is in continuity. A naso-gastric tube is passed from the nose down into the stomach
  This is a major thoracic procedure and complications include a leak from the anastomosis in 15% of patients; stricture (narrowing) in 30% and recurrent TOF in 10%.
  A leak can be a mild problem which seals spontaneously with non-operative management, to a severe problem requiring multiple operations, a prolonged stay in intensive care and hospital with short, medium and long-term problems. Sometimes the oesophagus has to be abandoned and replaced. Rarely death can occur.
  This study aims to see if a full randomised trail is feasible to see if indocyanine green(ICG) and near infrared fluorescence(NIRF) can predict or prevent patients developing an anastomotic leak or stricture

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  22/WM/0153

• Date of REC Opinion

  16 Aug 2022

• REC opinion

  Further Information Favourable Opinion