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

NCT02018705 | Terminated

• 2 other identifiers: PV4519Ethics Committee, Hamburg
• Study Type: observational
• Target: 47
• Locations: 4 countries
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• treatment success

  treatment success is defined as an Eckardt Score \</=3

  1 year after treatment

Secondary Outcomes (6)

• procedure related adverse events

  3 months after treatment

• lower esophageal sphincter pressure (LESP)

  3 months after treatment

• symptomatic reflux and use of antacid medication

  3 months after treatment

• procedure related adverse events

  12 months after treatment

• lower esophageal sphincter pressure (LESP)

  12 months after treatment

Other Outcomes (5)

• any reported GERD data

  procedure to five years after treatment

• duration of procedure

  procedure

• in-hospital stay

  procedure

Study Arms (2)

POEM

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

LHM

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Achalasia patients who have been treated with either POEM or LHM

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Aarhus University Hospital

Aarhus, 0708, Denmark

Location

University Hospital Eppendorf

Hamburg, 20246, Germany

Location

University Medical Center

Mainz, 55131, Germany

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

University Hospital

Zurich, 8006, Switzerland

Location

Related Publications (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.

  PMID: 19106675 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.

  PMID: 17703382 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.

  PMID: 20354937 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.

  PMID: 23389963 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.

  PMID: 22068665 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.

  PMID: 23665071 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.

  PMID: 21996484 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.

  PMID: 22609465 BACKGROUND

Study Officials

• Thomas Rösch, Prof. Dr.

  University Hospital Eppendorf, Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Interdisciplinary Endoscopy Department and Clinic

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

DK (1); DE (2); CH (1); NL (1)