Health Condition 1: K220- Achalasia of cardia
Conditions
Interventions
Intervention1: Short Myotomy: Patients in the Short Myotomy-group will undergo a Peroral Endoscopic Myotomy (POEM) extended for a total of 6 cm (including 4 cm above the esophago-gastric junction and
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Achalasia cardia (type I and II) 2. Eckardt score >3 3. Patient willing to undergo scheduled follow-up after POEM. 4. ASA class I or II
Exclusion criteria
Exclusion criteria: 1. Prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection will not be taken as exclusion criteria) 2. Pregnancy or nursing mothers 3. Severe co-morbid condition such as congestive heart failure, renal failure, or respiratory failure 4. Coagulopathy with INR >1.6 or platelet count 5. Cirrhosis with or without portal hypertension with or without esophageal varices 6. Secondary achalasia 7. Sigmoid esophagus: A sigmoid esophagus is tortuous (diameter > 6 cm) with axis deviation. Sigmoid achalasia is further classified into two types on the basis of computed tomography (CT)â??(i) Sigmoid type 1 (S1): the esophagus is significantly dilated and tortuous with single lumen only, (ii) Sigmoid type 2 (S2): the esophagus is very dilated and tortuous with double lumen on single CT slice 8. Epiphrenic esophageal diverticulum: Epiphrenic diverticulum are pulsion type diverticulum located in the distal esophagus. They are pseudodiverticulum and lack muscle layer. They are commonly associated with motility disorders, including achalasia cardia. Any epiphrenic diverticulum, which is large enough, and likely to require modification in the posterior myotomy, will be excluded from the study. 9. Any contra-indications for endoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of treatment success at 3 months and 1 year between short segment myotomy vs long segment myotomy.Treatment success will be defined based on Eckardtâ??s score. A score of 3 or less after the procedure will be defined as clinical success of the procedure.Timepoint: 3 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of adverse events between short segment myotomy vs long segment myotomy. The following Adverse events will be recorded: 1. Anesthesia related adverse events. 2. Insufflation related: subcutaneous emphysema, pneumothorax, pneumomediastinum, and pneumoperitoneum, hypercarbia 3. Hypercarbia 4. Mucosal injuries 5. Bleeding: intraprocedural and delayed. 6. Post procedure leak 7. Aspiration pneumonia 8. Fever/sepsis 9. Mediastinitis 10. Pleural effusion/empyema Timepoint: Intraprocedural and periprocedural;Comparison of change in barium column length and area from baseline at 3months and 1 year between short segment myotomy vs long segment myotomyTimepoint: 3 months and 1 year;Comparison of change in basal LES pressure from baseline at 3 months and 1 year between short segment myotomy vs long segment myotomyTimepoint: 3 months and 1 year;Comparison of change in Disease-specific-health-related quality of life for achalasia from baseline at 3 months and 1 year between short segment myotomy vs long segment myotomy. Disease-specific-health-related quality of life (QoL) for achalasia questionnaire developed and validated by David et al will be used to assess QoL before and after POEMTimepoint: 3 months and 1 year;Comparison of change in Dysphagia symptom scoring from baseline at 3 months and 1 year between short segment myotomy vs long segment myotomy. Dysphagia severity will be graded on a 5 point scale from 0-4 according to symptom scoring of modified Mellow and Pinkas scale.Timepoint: 3 months and 1 year;Comparison of change in Heartburn symptom scoring from baseline at 3 months and 1 year between short segment myotomy vs long segment myotomy. Heartburn will be graded on a 4-point scoring system according to modified symptom scoring of DeMeester.Timepoint: 3 months and 1 year;Comparison of change in IRP (Integrated relaxation pressure) from baseline at 3 months and 1 year between short segment myotomy vs long segment myotomyTimepoint: 3 months and 1 | — |
Countries
India
Contacts
Public ContactAshish Agarwal
All India Institute of Medical Sciences
Outcome results
None listed