Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia

NACompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

May 30, 2022

Study Completion Date

May 30, 2023

Conditions
Achalasia
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (8)

3000

University Hospital Leuven, Leuven

20246

Universitätsklinikum Eppendorf, Hamburg

86156

Klinikum Augsburg,Klinik für Innere Medizin III, Augsburg

97080

University Hospital Würzburg, Würzburg

Unknown

University Hospital Prague (IKEM), Prague

Istituto Clinico Humanitas, Rozzano

Academic Medical Center, Amsterdam

S141 86

Ersta Hospital and Karolinska University Hospital, Stockholm

All Listed Sponsors
collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

collaborator

Karolinska University Hospital

OTHER

collaborator

University Hospital Prague (IKEM), Prague, Czech Republic

UNKNOWN

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Istituto Clinico Humanitas

OTHER

collaborator

Wuerzburg University Hospital

OTHER

collaborator

University Hospital Augsburg

OTHER

lead

Universitätsklinikum Hamburg-Eppendorf

OTHER

NCT01601678 - Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia | Biotech Hunter | Biotech Hunter