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

Comparison of Long-term Success Rates of POEM With LHM Clinical Trial

— POEM3  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02018705
• Other study ID #: PV4519
• Secondary ID: Ethics Committee
• Status: Terminated
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comparison of Long-term Success Rates of POEM With LHM
• Comparison of Short- Term Success Rates of POEM With LHM
• Esophageal Achalasia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Germany	University Hospital Eppendorf	Hamburg
Germany	University Medical Center	Mainz
Netherlands	Academic Medical Center	Amsterdam
Switzerland	University Hospital	Zürich

Sponsors (7)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Aarhus University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Agaplesion Markus Krankenhaus, Johannes Gutenberg University Mainz, McGill Faculty of Medicine, University Hospital, Zürich

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  Switzerland, 

References & Publications (8)

Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstätter 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. Review. — View 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. — View 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. — View 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. — View Citation

Swanström 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. — View 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, Rösch 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. — View Citation

von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	any reported GERD data		procedure to five years after treatment
Other	duration of procedure	duration of procedure (minutes)	procedure
Other	in-hospital stay	in-hospital stay of patients (days)	procedure
Other	length of myotomy	length of myotomy (centimeters)	procedure
Other	procedure related complications	any complication during performance of treatment that required conversion to either laparoscopic (POEM) or open surgical treatment	procedure
Primary	treatment success	treatment success is defined as an Eckardt Score	1 year after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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