Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia (POEM3)

Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study

For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, long-term comparative data with LHM is required. Therefore,the intention for this study is to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

Study Overview

• Status: Terminated
• Conditions: Comparison of Short- Term Success Rates of POEM With LHM; Comparison of Long-term Success Rates of POEM With LHM

Detailed Description

Achalasia is a neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. The standard surgical treatment for achalasia is laparoscopic Heller Myotomy (LHM). A recent meta-analysis of 105 studies reporting on 7855 patients demonstrated that laparoscopic Heller myotomy is the most effective and long-lasting therapy for achalasia. Superior to Endoscopic balloon dilatation or Botulinumtoxin injection LHM has a one year therapeutic efficacy in approximately 90% of patients. Recently an endoscopic technique emulating the principles of LHM was developed. This technique of a purely endoscopic myotomy has been demonstrated by Pasricha et al. in animal experiments and Inoue et al. reported the first clinical study. Other pilot studies and a larger international multi-center trial have replicated promising results for POEM.

Uncontrolled studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, however, comparative data with LHM is required. Our study group intends to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 0708
    • Aarhus University Hospital
• Germany
  • Hamburg, Germany, 20246
    • University Hospital Eppendorf
  • Mainz, Germany, 55131
    • University Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Academic Medical Center
• Switzerland
  • Zürich, Switzerland, 8006
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Achalasia patients who have been treated with either POEM or LHM

Description

Inclusion Criteria:

• Patients with symptomatic achalasia and pre-op barium swallow, manometry and oesophago-gastro-duodenoscopy which have been consistent with the diagnosis
• Age > 18 years with medical indication for interventional achalasia treatment
• Availability of Eckardt score at baseline and 12 months after initial treatment

Exclusion Criteria:

• Patients with previous surgery of the stomach or esophagus
• Patients with known coagulopathy
• Previous surgical achalasia treatment
• Patients with liver cirrhosis and/or esophageal varices
• Active esophagitis
• Eosinophilic esophagitis
• Barrett's esophagus
• Stricture of the esophagus
• Malignant or premalignant esophageal lesion
• Severe Candida esophagitis
• Hiatal hernia > 1cm
• Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
POEM; group of Achalasia patients treated with POEM (peroral endoscopic myotomy)
LHM; group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment success	treatment success is defined as an Eckardt Score </=3	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure related adverse events	retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure	3 months after treatment
lower esophageal sphincter pressure (LESP)	retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure	3 months after treatment
symptomatic reflux and use of antacid medication	retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure	3 months after treatment
procedure related adverse events	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure	12 months after treatment
lower esophageal sphincter pressure (LESP)	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure	12 months after treatment
symptomatic reflux and use of antacid medication	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure	12 months after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
any reported GERD data		procedure to five years after treatment
duration of procedure	duration of procedure (minutes)	procedure
in-hospital stay	in-hospital stay of patients (days)	procedure
length of myotomy	length of myotomy (centimeters)	procedure
procedure related complications	any complication during performance of treatment that required conversion to either laparoscopic (POEM) or open surgical treatment	procedure

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Aarhus University Hospital; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Johannes Gutenberg University Mainz; University Hospital, Zürich; Agaplesion Markus Krankenhaus; McGill Faculty of Medicine
• Investigators: Principal Investigator: Thomas Rösch, Prof. Dr., University Hospital Eppendorf, Hamburg

Publications and helpful links

General Publications

• Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
• von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
• Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstatter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg. 2009 Jan;249(1):45-57. doi: 10.1097/SLA.0b013e31818e43ab.
• Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
• Zhou PH, Li QL, Yao LQ, Xu MD, Chen WF, Cai MY, Hu JW, Li L, Zhang YQ, Zhong YS, Ma LL, Qin WZ, Cui Z. Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. Endoscopy. 2013;45(3):161-6. doi: 10.1055/s-0032-1326203. Epub 2013 Feb 6.
• Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9.
• Swanstrom LL, Rieder E, Dunst CM. A stepwise approach and early clinical experience in peroral endoscopic myotomy for the treatment of achalasia and esophageal motility disorders. J Am Coll Surg. 2011 Dec;213(6):751-6. doi: 10.1016/j.jamcollsurg.2011.09.001. Epub 2011 Oct 13.
• Costamagna G, Marchese M, Familiari P, Tringali A, Inoue H, Perri V. Peroral endoscopic myotomy (POEM) for oesophageal achalasia: preliminary results in humans. Dig Liver Dis. 2012 Oct;44(10):827-32. doi: 10.1016/j.dld.2012.04.003. Epub 2012 May 19.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: POEM; LHM; Achalasia treatment; LES sphincter myotomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: PV4519; Ethics Committee, Hamburg (Registry Identifier: PV 4519)