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

NCT07167355 | Not Yet Recruiting DMC

• 1 other identifier: COS 1
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary: Clinical success is defined as • Eckardt score ≤ 3 • Absence of need for further endoscopic or surgical treatments to maintain Eckardt score ≤ 3 and • TBE showing oesophageal stasis of <5cm at 5minutes

  • Eckardt score is calculated based on chest pain, regurgitation, dysphagia and weight loss

  12 month

Secondary Outcomes (4)

• Secondary objective:

  12 month

• Percentage of patients developing gastroesophageal reflux disease

  12 months

• Minor complication rate

  12 months

• Change in growth

  12 months

Study Arms (2)

POEM

ACTIVE COMPARATOR

Procedure: POEM

BALLOON DILATATION

ACTIVE COMPARATOR

Children randomised to BD arm, will undergo BD of 20mm (Controlled radial expansion \[CRE\], Boston Scientific) following an overnight fast. The balloon will be positioned at the gastroesophageal junction and inflated to a diameter of 20mm and a note will be made of whether the waist has disappeared or not. A repeat session of BD will be done after 1 month if TBE reveals a holdup of \>5cm at 5 minutes. In this subgroup of children calculating Eckardt score will be difficult and unreliable. Balloon dilatation (children 7-17 years of age): 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 disappe

Procedure: BALLOON DILATATION

Interventions

POEM PROCEDURE

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

POEM

BALLOON DILATATION PROCEDURE

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

BALLOON DILATATION

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \> All children of age 3-17 years diagnosed as a case of achalasia cardia

You may not qualify if:

• Children who had previously underwent BD, LHM or POEM
• Type 3 achalasia cardia. In children in whom HRM is not possible, if symptoms or barium oesophagogram is classical of type 3 achalasia, they will be excluded.
• Prior history of oesophageal or gastric surgery
• Coagulopathy
• Alternative diagnosis

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Related Publications (3)

• Tang X, Gong W, Deng Z, Zhou J, Ren Y, Zhang Q, Chen Z, Jiang B. Usefulness of peroral endoscopic myotomy for treating achalasia in children: experience from a single center. Pediatr Surg Int. 2015 Jul;31(7):633-8. doi: 10.1007/s00383-015-3717-9. Epub 2015 May 9.

  PMID: 25957132 BACKGROUND

• de Moura ETH, Jukemura J, Ribeiro IB, Farias GFA, de Almeida Delgado AA, Coutinho LMA, de Moura DTH, Aissar Sallum RA, Nasi A, Sanchez-Luna SA, Sakai P, de Moura EGH. Peroral endoscopic myotomy vs laparoscopic myotomy and partial fundoplication for esophageal achalasia: A single-center randomized controlled trial. World J Gastroenterol. 2022 Sep 7;28(33):4875-4889. doi: 10.3748/wjg.v28.i33.4875.

  PMID: 36156932 BACKGROUND

• Mayberry JF, Mayell MJ. Epidemiological study of achalasia in children. Gut. 1988 Jan;29(1):90-3. doi: 10.1136/gut.29.1.90.

  PMID: 3343019 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dr.Mohan Kumar Ramchandani, MD, DM

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Srinivas srinidhi vadlapudi, MD, DM

CONTACT

96525221524; srinivas.vadlapudi19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Interventional Endoscopy

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 11, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share