Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

November 21, 2019

Primary Completion Date

November 13, 2023

Study Completion Date

November 13, 2023

Conditions
Esophageal Achalasia
Interventions
PROCEDURE

Esophageal biopsies during Peroral Endoscopic Myotomy (POEM)

"In total, 14 biopsies are performed with a pediatric biopsy forceps belonging to the study center: 3 biopsies at 3-6 cm above cardia, contralaterally from POEM, of which 2 are placed in nitrogen and 1 in formol for histopathological analysis; 3 biopsies at the cardia, contralaterally from POEM, of which 2 are placed in nitrogen and 1 in formol for histopathological analysis; 4 biopsies of the muscularis propria (exposed during POEM) at 3-6 cm above cardia, of which 3 are placed in nitrogen and 1 in formol for histopathological analysis; 4 biopsies of the muscularis propria at the cardia, of which 3 are placed in nitrogen and 1 in formol for histopathological analysis; The biopsies intended for histopathological analysis will be analyzed in FFOCT before histopathological analysis. The FFOCT analysis take place for the patient inclued after than 10 november 2020.~The biopsies are taken by the gastroenterologist who performs the POEM and is assisted by an endoscopy-specialized nurse."

Trial Locations (1)

Unknown

Nantes UH, Nantes

All Listed Sponsors
collaborator

Rennes University Hospital

OTHER

collaborator

University Hospital, Angers

OTHER_GOV

collaborator

LA ROCHE SUR YON HOSPITAL

UNKNOWN

collaborator

Hospices Civils de Lyon

OTHER

lead

Nantes University Hospital

OTHER

NCT04112693 - Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study. | Biotech Hunter | Biotech Hunter