Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

NACompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

April 1, 2017

Primary Completion Date

April 1, 2020

Study Completion Date

December 27, 2021

Conditions
Gastroparesis PostoperativeGastroparesis Due to Diabetes MellitusIdiopathic Gastric Stasis
Interventions
PROCEDURE

G-POEM

After confirmation of refractory gastroparesis, participants will undergo to gastric POEM. Participants will be admitted to hospital 24hrs before procedure and IV antibiotics will be given and then the procedure will be done. Technique consist of 4 steps: First: a submucosa injection of saline solution with methylene blue at 3-4cms from pylorus. Second: a submucosa incision and tunnel creation up to pyloric area. Third: Myotomy of the circular and longitudinal muscular layers of the pylorus and the antrum. Fourth: closure of the mucosal incision with hemoclips. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic and scintigraphic studies up to 1 year after procedure.

Trial Locations (1)

06700

Centro Medico Nacional Siglo XXI Hospital de Especialidades, Mexico City

All Listed Sponsors
lead

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

NCT03126513 - Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis | Biotech Hunter | Biotech Hunter