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

NCT ID: NCT02018705

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Comparison of Short- Term Success Rates of POEM With LHM; Comparison of Long-term Success Rates of POEM With LHM

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

POEM

group of Achalasia patients treated with POEM (peroral endoscopic myotomy)

No interventions assigned to this group

LHM

group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agaplesion Markus Krankenhaus

UNKNOWN

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

McGill Faculty of Medicine

UNKNOWN

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Rösch

Medical Director, Interdisciplinary Endoscopy Department and Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Rösch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Eppendorf, Hamburg

Locations

Aarhus University Hospital

Aarhus, , Denmark

University Hospital Eppendorf

Hamburg, , Germany

University Medical Center

Mainz, , Germany

Academic Medical Center

Amsterdam, , Netherlands

University Hospital

Zurich, , Switzerland

Countries

Denmark; Germany; Netherlands; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 19106675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17703382 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20354937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23389963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22068665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23665071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21996484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22609465 (View on PubMed)

Other Identifiers

Ethics Committee, Hamburg

Identifier Type: REGISTRY

Identifier Source: secondary_id

PV4519

Identifier Type: -

Identifier Source: org_study_id