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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Committee, Hamburg | Registry Identifier | PV 4519 |
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data income too low
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| Name | Class |
|---|---|
| Agaplesion Markus Krankenhaus | UNKNOWN |
| Johannes Gutenberg University Mainz | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POEM | group of Achalasia patients treated with POEM (peroral endoscopic myotomy) | ||
| LHM | group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication) |
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| Measure | Description | Time Frame |
|---|---|---|
| treatment success | treatment success is defined as an Eckardt Score \ | 1 year after treatment |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| any reported GERD data | procedure to five years after treatment | |
| duration of procedure | duration of procedure (minutes) | procedure |
Inclusion Criteria:
Exclusion Criteria:
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Achalasia patients who have been treated with either POEM or LHM
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Rösch, Prof. Dr. | University Hospital Eppendorf, Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 0708 | Denmark | |||
| University Hospital Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19106675 | Background | 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. | |
| 17703382 | Background | 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. |
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| McGill Faculty of Medicine |
| UNKNOWN |
| University Hospital, Zürich | OTHER |
| Aarhus University Hospital | OTHER |
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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 |
| 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 |
| Hamburg |
| 20246 |
| Germany |
| University Medical Center | Mainz | 55131 | Germany |
| Academic Medical Center | Amsterdam | 1105 | Netherlands |
| University Hospital | Zurich | 8006 | Switzerland |
| 20354937 | Background | 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. |
| 23389963 | Background | 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. |
| 22068665 | Background | 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. |
| 23665071 | Background | 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. |
| 21996484 | Background | 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. |
| 22609465 | Background | 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. |