70
Participants
Start Date
September 3, 2025
Primary Completion Date
October 22, 2027
Study Completion Date
July 15, 2028
POEM
Children randomised to POEM arm will undergo a single session of POEM following an overnight fast. The procedure will be done in supine position under general anaesthesia. A gastroscope (Olympus GIF-HQ190) with a transparent tapered cap fit at its distal end will be used. A mucosal bleb will be created using a 21G sclerotherapy needle and a solution of saline with indigo-carmine dye. A posterior approach will be followed in all patients. A small mucosal incision (2-3mm) will be made using a needle knife and enlarged using an insulated tip knife (2-3cm). The submucosal tunned will then be entered and the submucosal fibres will be cleared using a triangular tip knife (TriangularTipKnife J, Olympus). Full thickness will be performed in all patients. Length of the myotomy will be \~3cm in the oesophagus and \~2cm in the cardia of the stomach. Minor bleeding will be controlled using coagulation forceps. Mucosal injury and resistance at the gastroesophageal junction will be examined. Mucosal i
BALLOON DILATATION
"Children randomised to BD arm will undergo BD of 30mm (Rigiflex II, Achalasia balloon dilators, Boston Scientific) following an overnight fast. The balloon will be positioned at the gastroesophageal junction and inflated to a diameter of 30mm with a pressure of 5psi initially and gradually the pressure will be increased to a maximum of 15 psi till the disappearance of waist fluoroscopically. A note will be made at the pressure at which the waist disappears and will be maintained for 1 minute. One month after the initial session, if the Eckardt score \>3 or if the TBE shows a barium column of \>5cm at 5 minutes, a second session of BD will be done using a 35mm balloon.~These children will be kept nil per oral for 4 hours post procedure. They will be observed for signs of perforation (crepitus, hemodynamic instability, chest pain). If they are stable, a clear liquid (water) will be provided. If there is no pain, they will be discharged with an advise to follow soft diet for a day"
Asian Institute of Gastroenterology, India
OTHER