Achalasia Digestive System Achalasia of cardia
Conditions
Interventions
Endoscopic balloon dilation:
In this study EBD will be performed by experienced (pediatric) gastroenterologists that have independently performed at least 15 procedures. The procedure will be recorde
Sponsors
Amsterdam University Medical Centers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eckardt score >3 2. Presence of a HRM pattern consistent with achalasia type I or II according to the Chicago classification (CC) V3.0 criteria 3. Age 7 years up to 17 years inclusive
Exclusion criteria
Exclusion criteria: 1. Achalasia type III (this extremely rare subtype in children that is accompanied by esophageal spasm and associated complaints has a worse prognosis compared to type I and II. Literature and expert-opinion based recommendations suggest to treat type III with POEM. Randomizing these patients to EBD with a high a priori risk of relapses is therefore considered unethical) 2. Previous surgical or endoscopical achalasia treatment 3. Previous surgery of the upper gastrointestinal tract 4. Known coagulopathy 5. Known Liver cirrhosis and/or esophageal varices 6. Known LA grade =B esophagitis 7. Known Barrett’s esophagus 8. Known pregnancy at time of treatment 9. Stricture of the esophagus 10. Known presence of malignant or premalignant esophageal lesions 11. Hiatal hernia >1 cm based on HRM measurement 12. Extensive, tortuous dilatation (>7 cm luminal diameter, S shape) of the esophagus 13. Barium esophagram suggestive of other pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The need for any retreatment (also including retreatment that is planned before 12 months follow-up, but scheduled after 12 months follow-up), as suggested by the treating physician, using Eckhardt score, high-resolution manometry (HRM), and barium esophagram at 3, 6 and 12 months follow-up or during clinically indicated emergency interim visits. The indication for re-treatment is to be confirmed by a majority of three researchers who are blinded to the treatment arm of the patient. In case a patient does not adhere to the protocol, or is lost to follow-up, available data from the last included timepoint are used for estimation of the primary endpoint in an intention to treat analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achalasia symptoms defined by the Eckardt symptom score at 3, 6 and 12 months 2. Health-related and disease-specific quality of life (QoL) measured using the Pediatric Quality of Life inventory (PedsQL + PEDSQL-GI) and achalasia disease-specific QoL questionnaire (DSQoL) at 3, 6 and 12 months 3. Gastroesophageal reflux disease (GERD) symptoms defined by the reflux disease questionnaire (RDQ) at 3, 6 and 12 months 4. Grade of esophagitis defined by Los Angeles (LA) grade during esophagogastroduodenoscopy (EGD) at 12 months 5. Degree of GERD defined by 24-hour pH-impedance (pH-MII) measurement parameters at 12 months 6. Esophageal and lower esophageal sphincter function defined by high-resolution manometry (HRM) parameters at 12 months 7. Procedure-related complications (any unwanted events that arise following treatment and/or that are secondary to the treatment) measured using clinical symptoms and/or observation and appropriate additional testing at 3, 6 and 12 months 7.1. Severe: resulting in admission >24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, blood transfusion or death 7.2. Mild: all other complications 8. Procedure times measured using a digital timer at baseline intervention(s) and during the retreatment procedure 9. Growth (absolute growth in cm and kg, as well as relative growth measured as the change in SD scores [height for age and weight for height]) measured using the digital scale supplied by the hospital at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months 10. Cost-effectiveness evaluated using the hospital declaration system at 12 months | — |
Countries
Netherlands
Outcome results
None listed