240
Participants
Start Date
December 31, 2012
Primary Completion Date
May 30, 2022
Study Completion Date
May 30, 2023
Peroral Endoscopic Myotomy (POEM)
After lavage, measure gastro-esophageal junction (GEJ) in cm from mouth piece. Determine entry point 12-14cm above GEJ at the lesser curvature site, inject 10ml coloured saline, create entry point. Advance endoscope into the submucosa, dissect the submucosal tunnel up to 2-3cm into the cardia. Dissect the submucosa close to the muscularis and check endoluminally for the direction of the lesser curvature, sufficient extension onto the cardia and mucosal integrity. After tunnel completion flush with gentamycin and saline. Start myotomy from proximally to distally starting 4-5cm below the mucosal entry site; the inner circular muscle layer should be fully dissected especially at the cardia for good symptomatic results. It is vital that the mucosa of the tubular esophagus remains intact. Extend myotomy at least 2cm onto the cardia. After completion check for mucosal integrity and opening of the distal esophageal sphincter. Close the entry point with clips from distal to proximal.
Laparoscopic Heller Myotomy (LHM)
Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. Divide phrenoesophageal ligament starting on the right and mobilize distal esophagus on the lateral and anterior side. Identify and spare anterior vagal nerve. Perform myotomy by dividing both muscle-layers extending at least 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material.
University Hospital Leuven, Leuven
Universitätsklinikum Eppendorf, Hamburg
Klinikum Augsburg,Klinik für Innere Medizin III, Augsburg
University Hospital Würzburg, Würzburg
University Hospital Prague (IKEM), Prague
Istituto Clinico Humanitas, Rozzano
Academic Medical Center, Amsterdam
Ersta Hospital and Karolinska University Hospital, Stockholm
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Karolinska University Hospital
OTHER
University Hospital Prague (IKEM), Prague, Czech Republic
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Istituto Clinico Humanitas
OTHER
Wuerzburg University Hospital
OTHER
University Hospital Augsburg
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER