Comparison of Balloon Dilatation and Per Oral Endoscopic Myotomy in Children With Achalasia Cardia

Summary

To compare the efficacy of balloon dilatation (BD) and per oral endoscopic myotomy (POEM) in improving the symptoms of children with achalasia in short and long term Presently most guidelines such as American Society for Gastrointestinal Endoscopy (ASGE) or European Society for Gastrointestinal Endoscopy (ESGE) recommend POEM or LHM or BD for the management of achalasia cardia based on the institutional expertise and patient preference. Only the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommend POEM or LHM over PBD for the management of achalasia in children. This is due to the lack of pediatric randomised control trial comparing the efficacy and safety of the two methods both in long and short term.

Children 3-18 years of age diagnosed as a case of achalasia cardia Place of trial: Department of medical gastroenterology, AIG Hospitals, Gachibowli and Somajiguda/Banjara Hills Duration of the trial: 3-4 years Sample size: 70 (35 each arm) Inclusion criteria: All children diagnosed as a case of achalasia cardia aged 3-18 years Exclusion criteria: Children who have undergone prior BD or POEM or Heller's myotomy. Type 3 achalasia cardia. Prior oesophageal/gastric surgery. Coagulopathy. Patients refusing consent for the trial.

Primary outcome: Percentage of children with achalasia cardia achieving a clinical success of BD and POEM at 12 months post intervention (clinical success is Eckardt score ≤ 3 and timed barium esophagogram (TBE) showing a holdup at gastroesophageal junction of \<5cm at 5 minutes without requirement of further intervention) Secondary outcomes: Major and minor treatment complications, percentage patients developing gastroesophageal reflux disease, procedure time and improvement in growth Randomization: A stratified block randomization shall be performed using computer generated random number tables BD arm: Children \<7 years of age will under 1-2 sessions of BD 1month apart with CRE 20mm balloon. Children 7-17 years of age will undergo 1-2 sessions of BD with Rigiflex II, Achalasia balloon dilator (30mm followed by 35mm).

POEM arm: Children 3-17 years of age will undergo 1 session of POEM as per the unit protocol.

Outcomes will be assessed at 3,6,12 months of the index procedure Crossover: If Eckardt score \>3 and TBE showing a stasis of \>5cm at 5 minutes, treatment is considered to have failed and crossover will be offered Endpoints: One year of follow up from the initial intervention or one year of follow up of the crossover intervention (in case of treatment failure), major complications.

Interim analysis: Following completion of follow up of 50% of the trial participants Early termination of trial: In case of any treatment modality having \>10% major complications or during interim analysis one treatment modality significantly better than other (p\<0.003)

Conditions

• Achalasia Cardia

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India

  lead OTHER

Principal Investigators

• Dr.Mohan Kumar Ramchandani, MD, DM · AIG Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

3 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-03

Primary Completion

2027-10-22

Completion

2028-07-15