CLINICAL TRIAL

Short Myotomy for Megaesophagus

EnrollingByInvitation · 18+ · All Sexes · Chicago, IL

This study is evaluating whether a shorter myotomy is as effective as a standard length myotomy.

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About the trial for Megaesophagus

Eligible Conditions
Esophageal Achalasia · Achalasia

Treatment Groups

This trial involves 2 different treatments. Short Myotomy is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Short Myotomy
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard Length Myotomy
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
All patients aged 18+ diagnosed with Type I or Type II achalasia, and patients with EGJ Outflow Obstruction with features of achalasia based on HRM or Endoscopic Functional Lumen Imaging Probe (EndoFLIP)
All subjects must have given signed, informed consent prior to registration in the study
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Short Myotomy will improve 1 primary outcome and 3 secondary outcomes in patients with Megaesophagus. Measurement will happen over the course of 1 year.

Compare procedural time and intra-procedural findings between 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
1 YEAR
We will record procedure times and procedural findings including submucosal tunnel length, position of myotomy, cautery settings for myotomy, need for revision of myotomy and endoclips used for tunnel closure.
1 YEAR
Compare procedure complications after 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
1 YEAR
We will monitor for any evidence of complications post-procedure including bleeding, perforation and blown-out myotomy.
1 YEAR
Compare post-POEM gastro-esophageal reflux between 4 cm myotomy and 8 cm myotomy using GERDQ assessment.
2 YEARS
At 1, 6 and 12 months, patient reported outcome of acid reflux will be assessed. The GERDQ is a validated survey tool to assess acid reflux symptoms. Scores range from 0-18 with a higher score indicating worse symptoms.
2 YEARS
Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy
2 YEARS
At 1, 6 and 12 months, patient reported outcome of achalasia symptoms will be assessed. The Eckardt Score is a validated research tool for achalasia symptoms. Scores range from 0-12. A higher score indicates worse symptoms. We will compare Eckardt Score pre-POEM and post-PEM at various time points.
2 YEARS

Who is running the study

Principal Investigator
A. A. A.
Prof. A. Aziz Aadam, Associate Professor of Medicine
Northwestern University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for megaesophagus?

[Megaesophagus] was shown to be related to age, male sex, high BMI, dysphagia, and [other variables] (P<0.05). Clinical trials for the treatment of patients with megaesophagus may be necessary.

Anonymous Patient Answer

What causes megaesophagus?

Patients with megaesophagus are more likely to have a prior surgical or medical condition, such as malignancy or congenital deformity. The underlying cause of megacolon or malformation of the stomach cannot be determined, but it may be an isolated condition.

Anonymous Patient Answer

What are common treatments for megaesophagus?

There is no conclusive evidence on the efficacy of endoscopic therapy and other non-surgical treatments for megaesophagus. There is, however, some evidence for surgical therapy. In particular, endoscopic dilation and laser ablation have been used. Despite all of this, definitive surgical therapy of megaesophagus remains the treatment for choice by specialists.

Anonymous Patient Answer

Can megaesophagus be cured?

The majority of patients who have long-term symptoms have symptoms resolve with the use of proton pump inhibitors, but the risk of relapse is high. Recent findings support ongoing surveillance for symptom evolution and symptom alleviation.

Anonymous Patient Answer

What is megaesophagus?

Megaesophagus is an abnormally thickened muscular segment of the oesophageal wall in which a muscular gap can be seen on an upper GI endoscopy. Megaesophagus is not associated with pathological reflux.

Anonymous Patient Answer

What are the signs of megaesophagus?

The diagnosis of megaesophagus cannot be based on symptoms alone. A high degree of suspicion for megaesophagus is necessary for diagnosing the disorder early and preventing unnecessary investigations, unnecessary treatment and delays to surgery.

Anonymous Patient Answer

How many people get megaesophagus a year in the United States?

The incidence of megaesophagus is low, at around 1 per 100,000 per year. The incidence of megaesophagus remains fairly stable over time and over different age groups. It is most frequently diagnosed in older men with a history of peptic ulcer disease.

Anonymous Patient Answer

Does megaesophagus run in families?

No significant results (p < 0.05) were recorded in the frequency of megaesophagus among affected families and control families. This result may be due to the differences in occurrence in the families of some cases and also the small number of cases.

Anonymous Patient Answer

What are the latest developments in short myotomy for therapeutic use?

The short myotomy remains a commonly accepted treatment for achalasia, but recent technological advancements have created new treatment options for surgeons and endoscopists with the help of an advanced surgical endoscope.

Anonymous Patient Answer

Does short myotomy improve quality of life for those with megaesophagus?

MME for correction of oesophageal dysmotility does not improve the quality of life of patients at rest and during the day, and has a negative impact on the general health of patients.

Anonymous Patient Answer

Have there been any new discoveries for treating megaesophagus?

Because of the current availability of only one treatment method for megaesophagus, we believe that new treatment methods in this area are very necessary to develop the appropriate type of treatment and to select appropriate candidates for treatment.

Anonymous Patient Answer

Is short myotomy typically used in combination with any other treatments?

Patients treated with short myotomy with either endoscopic or open surgery typically respond well with improvement in cough, pain, and swallowing. The long-term results of these treatments are not clear because of the small sample size and our short follow-up at this time. Despite this study, surgeons and referral centers should continue their experience with short myotomy, because patients seem to have a higher success rate.

Anonymous Patient Answer
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