Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia (POEMrct)
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|ClinicalTrials.gov Identifier: NCT01601678|
Recruitment Status : Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Peroral Endoscopic Myotomy (POEM) Procedure: Laparoscopic Heller Myotomy (LHM)||Not Applicable|
Achalasia is considered a primary esophageal motility disorder which is defined as an insufficient relaxation of the lower esophageal sphincter. Incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus are characteristics of achalasia. Incidence peaks between ages 20 to 40. The most commonly reported symptoms are dysphagia (both for solids and liquids), regurgitation, and chest pain. The diagnosis is established with esophageal manometry and barium swallow radiographic studies and also with endoscopy being performed to exclude neoplastic or inflammatory diseases. Endoscopic therapies consist of either balloon dilatation (EBD) or Botulinum toxin injection (EBTI). The surgical treatment for achalasia is Heller Myotomy, nowadays almost exclusively performed laparoscopically.Superior to EBD and EBTI, surgical myotomy has shown sustained therapeutic efficacy in approximately 90% of patients which may be especially relevant for young patients with achalasia.
Recently an endoscopic technique to create myotomy via a submucosal tunnel has been developed, named PerOral Endoscopic Myotomy (POEM). The technique was first reported by Pasricha et al. in a porcine study, and Inoue et al. later reported the first clinical results in achalasia patients which showed significantly reduced dysphagia symptom scores and decreased resting lower esophageal sphincter (LES) pressures in 17 patients with a mean follow-up of 5 months . No serious complications related to POEM were encountered in this initial single-center trial. Several smaller pilot studies from Asia, Europe and USA have replicated the promising results regarding feasibility, safety and short-term efficacy,leading us to hope for a similar success rate along with reduced patient discomfort At present, POEM has the potential to be the first scarless flexible endosurgical intervention to become an established clinical treatment.The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. For POEM to be integrated into clinical routine, comparative data regarding safety and efficacy are necessary.Our study group intends to compare safety and long-term efficacy of POEM to laparoscopic Heller myotomy, the current gold-Standard, in a non-inferiority design.
Patients with symptomatic achalasia and medical indication for interventional therapy will be randomized to either POEM therapy or standard laparoscopic Heller myotomy (with anti-reflux procedure)(LHM). They will be followed up closely in a defined time pattern evolving individual life quality and achalasia scores as well as clinical scores and diagnostics over a period of 5 years.
Due to considerations concerning the comparability to other achalsia Trials (Boeckxstaens,NEJM 2011), in November 2012 primary outcome has been changed to Eckardt Score instead of lower sphicter pressure. Amendment was done before patient inclusion started. Sample size was not affected by amendment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Peroral Endoscopic Myotomy POEM
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group
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.
Active Comparator: Laparoscopic Heller Myotomy LHM
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group.
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.
- Eckhard symptom scores [ Time Frame: 2 years after treatment ]Achalasia symptom questionnaire to evaluate individual therapy success, range from 0 (no Achalasia symptoms) to 12 (full symptom range), treatment success is defined as an Eckardt Score ≤ 3
- Eckhard symptom scores [ Time Frame: before,and 3 and 6 months, 1,3 and 5 years past procedure ]Achalasia symptom questionnaire to evaluate individual therapy success, range from 0 (no Achalasia symptoms) to 12 (full symptom range)
- Treatment success rates [ Time Frame: 3 and 6 months, and 1, 3, and 5 years post procedure ]success rates result from Eckardt Scores
- Manometry data [ Time Frame: before, and 3 months, and 2 and 5 years post procedure ]Achalasia subtypes (before treatment) and assessment of lower esophagus sphincter function
- Reflux score (clinical DeMeester score) [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ]clinical DeMeester Reflux questionnaire to evaluate therapeutic side effects, range from 0 (no Reflux symptoms) to 6 (full symptom range).
- Reflux symptoms [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ]List of side effects due to reflux past POEM as short term and long term outcomes
- pH metry [ Time Frame: 3 months and 2 and 5 years after therapy ]pH metry data after therapy
- Adverse Events [ Time Frame: Baseline to five years past procedure ]complication rate (Adverse Events (AE) and Serious Adverse Events (SAE))
- Quality of Life index [ Time Frame: before, and 3 months, and 2 and 5 years post procedure ]Life quality assessment (gastrointestinal LQ index by Eypasch, Wood-Dauphinee and Troidl) for individual success Evaluation (GIQLI), Best outcome score is 144.
- EGD findings [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ]EGD findings to evaluate reflux effects after therapy
- CRP lab values [ Time Frame: day before procedure to day after procedure ]CRP values measured in mg/l (milligrams per litre) pre and post procedure
- Hb lab values [ Time Frame: day before procedure to day after procedure ]Hemoglobin values measured in g/dl (grams per decilitre) pre and post procedure
- Leucocyte lab values [ Time Frame: day before procedure to day after procedure ]Leucocyte values measured in billions per litre pre and post procedure, number of days of hospitalisation, myotomy length, duration of procedure
- number of days of hospitalisation [ Time Frame: through inhouse stay after procedure, an average of 2-7 days ]inhouse stay after procedure
- myotomy length [ Time Frame: day of procedure ]myotomy length in cm
- duration of procedure [ Time Frame: day of procedure ]duration of procedure in minutes
- Therapy failures [ Time Frame: from procedure to 5 years after procedure ]number of therapy failures
- Retreatments [ Time Frame: from procedure to 5 years after procedure ]number and kinds of retreatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601678
|University Hospital Leuven|
|Leuven, Belgium, 3000|
|University Hospital Prague (IKEM)|
|Klinikum Augsburg,Klinik für Innere Medizin III|
|Augsburg, Germany, 86156|
|Hamburg, Germany, 20246|
|University Hospital Würzburg|
|Würzburg, Germany, 97080|
|Istituto Clinico Humanitas|
|Academic Medical Center|
|Ersta Hospital and Karolinska University Hospital|
|Stockholm, Sweden, S141 86|
|Study Director:||Thomas Roesch, Prof.||Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, Germany|
|Principal Investigator:||Paul Fockens, Prof.||Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; Netherlands|
|Principal Investigator:||Bengt Håkanson, Prof.||Department of Surgery, Karolinska University Hospital, Stockholm, Sweden|
|Principal Investigator:||Guy Boeckxstaens, Prof.||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||C.T. Germer, Prof.||Wuerzburg University Hospital|
|Principal Investigator:||Riccardo Repici, Prof.||Istituto Clinico Humanitas, Rozzano, Italy|
|Principal Investigator:||Uberto Fumagalli, Prof.||Istituto Clinico Humanitas, Rozzano, Italy|
|Principal Investigator:||Julius Spicak, Prof.||University Hospital Prague, Prague, Czech Republic|
|Principal Investigator:||Helmut Messmann, Prof.||Department for Internal Medicine III, Klinikum Augsburg, Germany|