Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Achalasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pneumatic Dilation

Subject with achalasia undergoing routine care EGD (Esophagogastroduodenoscopy) with pneumatic dilation

pneumatic dilation

Intervention Type PROCEDURE

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.

Surgical Myotomy

Subject with achalasia undergoing routine care EGD with surgical myotomy

surgical myotomy

Intervention Type PROCEDURE

This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.

Interventions

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pneumatic dilation

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.

Intervention Type PROCEDURE

surgical myotomy

This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject is able to provide written informed consent to participate in the study before completing any study-related procedures
2. Subject is male or female aged 18-75 years, inclusive at time of consent.
3. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report.
4. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia.
5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.

Exclusion Criteria

1. 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.
2. Subject has had previous pneumatic dilation of treatment of achalasia.
3. Subject has had botulinum toxin (botox) injection for treatment of achalasia.
4. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No