Study on Lansoprazole for Preventing Acid Reflux in Patients with Esophageal Achalasia After Endoscopic Myotomy

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What is this study about?

This clinical trial focuses on a condition called esophageal achalasia, which affects the ability of the esophagus to move food toward the stomach. The study is examining the use of a medication called Lansoprazole, which is taken as orodispersible tablets, meaning they dissolve in the mouth. The purpose of the study is to evaluate whether taking Lansoprazole regularly for 12 months is more effective in preventing acid reflux compared to taking it only when symptoms appear, after a procedure known as POEM (Peroral Endoscopic Myotomy) for treating esophageal achalasia.

Participants in the study will be randomly assigned to one of two groups. One group will receive routine treatment with Lansoprazole for a year, while the other group will take the medication only if they experience symptoms of acid reflux. The study will monitor the presence of acid reflux at 6 months and again at 12 months. This will help determine the effectiveness of the treatment in preventing acid reflux, which can cause discomfort and other complications.

Throughout the study, various aspects will be assessed, including the quality of life of participants, the amount of Lansoprazole consumed, and any adverse reactions. Additionally, the study will evaluate the presence of esophagitis, a condition where the esophagus becomes inflamed, and other related symptoms. The trial aims to provide valuable insights into the best approach for managing acid reflux in patients who have undergone the POEM procedure for esophageal achalasia.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose and procedures. The patient must provide informed consent, confirming understanding and willingness to participate.

Eligibility criteria include being an adult (18 years or older) with esophageal achalasia, having an Eckardt score greater than 3, and being affiliated with a health insurance plan.

2 randomization

The patient will be randomly assigned to one of two groups. One group will receive routine treatment with lansoprazole for 12 months, while the other group will receive lansoprazole only if symptoms occur.

3 treatment phase

If assigned to the routine treatment group, the patient will take lansoprazole 30mg orodispersible tablets orally every day for 12 months.

If assigned to the symptom-based treatment group, the patient will take lansoprazole only if symptoms of acid reflux occur.

4 6-month evaluation

At 6 months, the patient will undergo an evaluation to check for acid reflux. This may include tests like esophageal pH-metry, which measures acid exposure in the esophagus over 24 hours.

The presence of esophagitis, a condition where the esophagus becomes inflamed, will also be assessed.

5 12-month evaluation

At 12 months, another evaluation will be conducted to assess acid reflux and esophagitis. Additional tests may include pH-impedancemetry, which measures both acid and non-acid reflux.

Quality of life questionnaires will be completed to assess the impact of treatment on daily living.

6 end of trial

Upon completion of the trial, the patient’s participation will conclude. The patient will be informed of any relevant findings related to their health and the study’s outcomes.

Who Can Join the Study?

Patient with an indication for esophageal POEM for achalasia. POEM stands for Peroral Endoscopic Myotomy, a procedure used to treat swallowing disorders.
Patient with all types of achalasia with Eckardt score greater than 3. The Eckardt score is a system used to measure the severity of symptoms in achalasia, such as difficulty swallowing and chest pain.
Patient with free and informed consent. This means the patient understands the study and agrees to participate.
Patient affiliated or beneficiary of a health insurance plan. This means the patient must have health insurance coverage.
Adult patient (18 years old or older).

Who Cannot Join the Study?

Patients who have not been diagnosed with esophageal achalasia cannot participate. Esophageal achalasia is a condition where the esophagus, the tube that carries food from the mouth to the stomach, has trouble moving food down.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are part of a vulnerable population, such as those who cannot give consent for themselves, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hopital Saint Eloi	Montpellier	France
Altukptldt Pbxqjwod Hxkvscic Dd Mgaookqzc	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.01.2023

Trial locations

Investigated drugs:

Lansoprazole

PPI stands for proton pump inhibitors, which are a type of medication that helps reduce the amount of acid produced in the stomach. In this clinical trial, PPIs are being used to see if taking them regularly for 12 months can help prevent acid reflux in patients who have undergone a procedure called POEM for a condition known as esophageal achalasia. Esophageal achalasia is a disorder that makes it difficult for food and liquid to pass into the stomach. By reducing stomach acid, PPIs may help prevent discomfort and potential damage caused by acid reflux.

Esophageal achalasia – Esophageal achalasia is a disorder where the esophagus, the tube that carries food from the mouth to the stomach, has trouble moving food down into the stomach. This happens because the lower esophageal sphincter, a ring of muscle at the end of the esophagus, fails to relax properly. As a result, food can get stuck in the esophagus, leading to difficulty swallowing. Over time, the esophagus may become dilated or widened due to the accumulation of food. This can cause discomfort, chest pain, and regurgitation of undigested food. The condition progresses slowly and can lead to significant changes in eating habits and weight loss.

Trial ID:

2022-500218-25-01

Protocol code:

GCSMERRI/2020/LC-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lansoprazole for Preventing Acid Reflux in Patients with Esophageal Achalasia After Endoscopic Myotomy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?