Interest of systematic treatment with PPI after endoscopic myotomy compared to PPI treatment in case of symptoms in prevention of gastroesophageal reflux after POEM for esophageal achalasia. Randomized open-label clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHU de Nimes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

1 Jun 2023 → ongoing

Decision date (initial)

2023-02-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU NIMES

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the impact of routine PPI therapy for 12 months versus PPI therapy if indicated on the rate of acid reflux at 6 months in patients who received POEM for esophageal achalasia

Secondary objectives 6

1. To evaluate the impact of routine PPI therapy for 12 months versus PPI on demand therapy on acid reflux rate as defined by the Lyon criteria at 12 months
2. To evaluate the impact of systematic treatment with PPI for 12 months versus treatment with PPI on demand on Quality of Life.
3. To evaluate the impact of systematic PPI treatment over 12 months versus PPI on demand treatment on the quantity of PPI consumed (PPI logbook) over 12 months
4. To evaluate the impact of routine PPI therapy over 12 months versus PPI on-demand therapy on treatment tolerance over 12 months (defined as the occurrence of adverse events)
5. To assess the impact of 12 months of routine PPI therapy versus PPI on demand therapy on the recurrence of achalasia symptoms over the 12-month follow-up period (Eckardt score >3)
6. To evaluate the impact of routine PPI treatment over 12 months versus PPI on demand treatment on the phenotype of pyrosis symptoms in achalasia treated according to the Rome IV criteria (27) (Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis)

Conditions and MedDRA coding

esophageal achalasia

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient with an indication for esophageal POEM for achalasia
2. Patient with all types of achalasia with Eckardt score > 3
3. Patient with free and informed consent.
4. Patient affiliated or beneficiary of a health insurance plan.
5. Adult patient (≥18 years old).

Exclusion criteria 8

1. Patients with contraindications to PPIs (Specify major ICs)
2. Patient with mediastinal and esophageal neoplasia
3. Patients with a history of Heller myotomy surgery
4. Patients requiring any type of anti-reflux valve surgery
5. Patient in an exclusion period determined by another study.
6. Patient under court protection, guardianship or curatorship.
7. Patient for whom it is impossible to give informed information.
8. Pregnant, parturient, or breastfeeding patient.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Presence of pathological acid reflux according to the Lyon 2018 criteria (26) at 6 months: This is a composite endpoint presence of: - Esophagitis grade C or D according to the Los Angeles classification. And / or - Acid exposure >6% on 24-hour esophageal pH-metry.

Secondary endpoints 6

1. Presence of pathologic acid reflux according to the 2018 Lyon criteria (26) at 12 months: A) Esophagitis grade C or D B) Acid exposure >6% at 24-hour pH impedancemetry
2. Score aux questionnaires de qualité de vie : A) WHOQOL-BREF B) GERD HRQL
3. Quantity of Lansoprazole consumed (Number of boxes consumed): generic form
4. Occurrence of an adverse reaction
5. Post POEM dysphagia assessment: Eckardt score >3
6. Assessment of pH-impedancemetry profile at 6 and 12 months defined by Rome IV criteria (Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU de Nimes

Sponsor organisation

CHU de Nimes

Address

4 Place Du Professeur Robert Debre

City

Nimes Cedex 9

Postcode

30029

Country

France

Scientific contact point

Organisation

CHU de Nimes

Contact name

Sabrina NICOLAS

Public contact point

Organisation

CHU de Nimes

Contact name

Sabrina NICOLAS

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications