Clinical trial NCT02018705: Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia
Official title: Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Comparison of Short- Term Success Rates of POEM With LHM
Comparison of Long-term Success Rates of POEM With LHM
Keywords: POEM
LHM
Achalasia treatment
LES sphincter myotomy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Agaplesion Markus Krankenhaus
name: Johannes Gutenberg University Mainz
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: McGill Faculty of Medicine
name: University Hospital, Zürich
name: Aarhus University Hospital
First posted: 2013-12-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Achalasia patients who have been treated with either POEM or LHM

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: treatment success
timeFrame: 1 year after treatment
Secondary outcomes:
measure: procedure related adverse events
timeFrame: 3 months after treatment
measure: lower esophageal sphincter pressure (LESP)
timeFrame: 3 months after treatment
measure: symptomatic reflux and use of antacid medication
timeFrame: 3 months after treatment
measure: procedure related adverse events
timeFrame: 12 months after treatment
measure: lower esophageal sphincter pressure (LESP)
timeFrame: 12 months after treatment
measure: symptomatic reflux and use of antacid medication
timeFrame: 12 months after treatment
Other outcomes:
measure: any reported GERD data
timeFrame: procedure to five years after treatment
measure: duration of procedure
timeFrame: procedure
measure: in-hospital stay
timeFrame: procedure
measure: length of myotomy
timeFrame: procedure
measure: procedure related complications
timeFrame: procedure
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hamburg
country: Germany
facility: University Hospital Eppendorf
city: Mainz
country: Germany
facility: University Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Zürich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital Eppendorf, Hamburg
name: Thomas Rösch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.