Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal 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

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2028-02-29

Brief Summary

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Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.

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Detailed Description

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Conditions

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Esophageal Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Systematic protein pump inhibitor therapy

Group Type EXPERIMENTAL

Protein pump inhibitor therapy systematically

Intervention Type DRUG

Lansoprazole 30mg once per day

Protein pump inhibitor therapy as necessary

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Protein pump inhibitor therapy systematically

Lansoprazole 30mg once per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with an indication for esophageal POEM for achalasia
* Patient with all types of achalasia with Eckardt score \> 3
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria

* Patient with contraindications to PPIs
* Patient with mediastinal and esophageal neoplasia
* Patient with a history of Heller myotomy surgery
* Patients requiring any type of anti-reflux valve surgery
* The subject is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No