Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

NCT03063463 | Enrolling By Invitation

• 1 other identifier: 161769
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pneumatic Dilation

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

Procedure: pneumatic dilation

Surgical Myotomy

Subject with achalasia undergoing routine care EGD with surgical myotomy

Procedure: surgical myotomy

Interventions

pneumatic dilation 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.

Pneumatic Dilation

surgical myotomy PROCEDURE

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

Surgical Myotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator or a sub-investigator as part of their routine care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum sample will be collected for future genomic analysis.

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Vaezi, MD,PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 15, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)