Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

Study Overview
=================
Brief Summary
-----------------
Currently there are no existing data to determine why some achalasia patients lose weight while others do not. The purpose of this study is to gather data from patients diagnosed with achalasia to determine if differences may be identified between those who lose weight and those who do not that would help us better understand the mechanism of weight loss in this population.

Detailed Description
-----------------
Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. Blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. These data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.

Official Title
-----------------
Mechanisms of Weight Loss in Patients Diagnosed With Achalasia: A Prospective Observational Study

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: pneumatic dilation
* Procedure: surgical myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to provide written informed consent to participate in the study before completing any study-related procedures Subject is male or female aged 18-75 years, inclusive at time of consent. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol. Exclusion Criteria: Subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery. Subject has had previous pneumatic dilation of treatment of achalasia. Subject has had botulinum toxin (botox) injection for treatment of achalasia. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pneumatic Dilation<br>Subject with achalasia undergoing routine care EGD (Esophagogastroduodenoscopy) with pneumatic dilation | Procedure: pneumatic dilation<br>* Pneumatic dilation of the lower esophageal sphincter (LES) consists of inserting a guide wire under visual control into the stomach and to pass the balloon over the guide wire. The balloon is inflated, disrupting the muscle fibers of the sphincter.<br>|
| Surgical Myotomy<br>Subject with achalasia undergoing routine care EGD with surgical myotomy | Procedure: surgical myotomy<br>* This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Currently there are no existing data to determine why some achalasia patients lose weight while others do not. The purpose of this study is to determine if differences may be identified between those who lose weight and those who do not. Body weight will be monitored at study visits throughout the study. | One year |