Hot Water Drinking Therapy in Achalasia

Study Overview
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Brief Summary
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From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.

Detailed Description
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Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

Official Title
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Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients

Conditions
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Achalasia

Intervention / Treatment
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* Other: hot water drinking therapy
* Procedure: Pneumatic dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: achalasia patients diagnosed by endoscopy, barium esophagram and manometry Exclusion Criteria: could not drink water poor compliance severe comorbidities esophageal stenosis secondary to erosions and cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot water drinking therapy<br>Hot water drinking before,after meal and before sleep | Other: hot water drinking therapy<br>* Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep<br>|
| Active Comparator: Pneumatic dilation<br>Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation | Procedure: Pneumatic dilation<br>* Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline achalasia symptom score at 1 month | Dysphagia, Regurgitation and Chest Pain scores | baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse effects | adverse effects of drinking water like distention, nausea and belching | Week 1 | 
| Change from baseline in barium esophagram at 1 year | measure esophageal diameter | baseline and 1 year | 
| Endoscopy at 1 year | esophageal bezoars and esophageal cancer | year 1 | 
| Pneumatic dilation rate and relative efficacy | Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation | any time | 
| Change from baseline in achalasia symptom score at 1 year | Dysphagia,Regurgitation and Chest Pain scores | baseline and 1 year | 
| Change from baseline achalasia symptom scores at 5 years | Dysphagia,Regurgitation and Chest Pain scores | baseline and 5 years | 
| Change from baseline in barium esophagram at 5 years | measure esophageal diameter | baseline and 5 years | 
| Endoscopy at 5 years | esophageal bezoars and esophageal cancer | year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, Hot water drinking therapy, Pneumatic dilation