NCT01601678

Brief Summary

Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus leading to dysphagia, regurgitation, and chest pain. therapies for achalasia consist of endoscopic balloon dilatation (EBD) and botulinum toxin injection (EBTI), or surgical Treatment via i Heller Myotomy; surgery is nowadays mostly performed via the laparoscopic approach. Surgical therapy demonstrated superior treatment efficacy compared to EBD and EBTI. Recently, an endoscopic means to perform myotomy via a submucosal tunnel has been developed, namely PerOral Endoscopic Myotomy (POEM). Uncontrolled studies have indicated a symptomatic success rate of \>90% for POEM in short term follow-ups.The aim of this study is to compare short and long-term feasibility, safety and efficacy of endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

9.5 years

First QC Date

May 15, 2012

Last Update Submit

June 27, 2023

Conditions

Achalasia

Keywords

AchalasiaHeller MyotomyDysphagiaPeroral Endoscopic MyotomyLHMPOEM

Outcome Measures

Primary Outcomes (1)

  • Eckhard symptom scores

    Achalasia symptom questionnaire to evaluate individual therapy success, range from 0 (no Achalasia symptoms) to 12 (full symptom range), treatment success is defined as an Eckardt Score ≤ 3

    2 years after treatment

Secondary Outcomes (17)

  • Eckhard symptom scores

    before,and 3 and 6 months, 1,3 and 5 years past procedure

  • Treatment success rates

    3 and 6 months, and 1, 3, and 5 years post procedure

  • Manometry data

    before, and 3 months, and 2 and 5 years post procedure

  • Reflux score (clinical DeMeester score)

    before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure

  • Reflux symptoms

    before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure

  • +12 more secondary outcomes

Study Arms (2)

Peroral Endoscopic Myotomy POEM

ACTIVE COMPARATOR

Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group

Procedure: Peroral Endoscopic Myotomy (POEM)

Laparoscopic Heller Myotomy LHM

ACTIVE COMPARATOR

Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group.

Procedure: Laparoscopic Heller Myotomy (LHM)

Interventions

Peroral Endoscopic Myotomy (POEM)PROCEDURE

After lavage, measure gastro-esophageal junction (GEJ) in cm from mouth piece. Determine entry point 12-14cm above GEJ at the lesser curvature site, inject 10ml coloured saline, create entry point. Advance endoscope into the submucosa, dissect the submucosal tunnel up to 2-3cm into the cardia. Dissect the submucosa close to the muscularis and check endoluminally for the direction of the lesser curvature, sufficient extension onto the cardia and mucosal integrity. After tunnel completion flush with gentamycin and saline. Start myotomy from proximally to distally starting 4-5cm below the mucosal entry site; the inner circular muscle layer should be fully dissected especially at the cardia for good symptomatic results. It is vital that the mucosa of the tubular esophagus remains intact. Extend myotomy at least 2cm onto the cardia. After completion check for mucosal integrity and opening of the distal esophageal sphincter. Close the entry point with clips from distal to proximal.

Peroral Endoscopic Myotomy POEM
Laparoscopic Heller Myotomy (LHM)PROCEDURE

Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. Divide phrenoesophageal ligament starting on the right and mobilize distal esophagus on the lateral and anterior side. Identify and spare anterior vagal nerve. Perform myotomy by dividing both muscle-layers extending at least 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material.

Laparoscopic Heller Myotomy LHM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic achalasia with an Eckardt score of \> 3 and pre-op barium swallow, manometry and esophagogastroduodenoscopy consistent with the diagnosis
  • Persons of age \> 18 years with medical indication for surgical myotomy or EBD
  • Signed written Informed Consent

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
  • Pregnancy
  • 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
  • Advanced malignant tumor with prognosis \< 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital Leuven

Leuven, 3000, Belgium

Location

University Hospital Prague (IKEM)

Prague, Czechia

Location

Klinikum Augsburg,Klinik für Innere Medizin III

Augsburg, 86156, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, 20246, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Ersta Hospital and Karolinska University Hospital

Stockholm, S141 86, Sweden

Location

Related Publications (14)

  • 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: 19106675BACKGROUND

  • von Rahden BH, Germer CT. [Laparoscopic myotomy for achalasia is clearly superior to the endoscopic treatment]. Chirurg. 2010 Jan;81(1):69-70. doi: 10.1007/s00104-009-1840-7. No abstract available. German.

    PMID: 19940967BACKGROUND

  • Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.

    PMID: 19092347BACKGROUND

  • Ortiz A, de Haro LF, Parrilla P, Lage A, Perez D, Munitiz V, Ruiz D, Molina J. Very long-term objective evaluation of heller myotomy plus posterior partial fundoplication in patients with achalasia of the cardia. Ann Surg. 2008 Feb;247(2):258-64. doi: 10.1097/SLA.0b013e318159d7dd.

    PMID: 18216530BACKGROUND

  • Perretta S, Dallemagne B, Allemann P, Marescaux J. Multimedia manuscript. Heller myotomy and intraluminal fundoplication: a NOTES technique. Surg Endosc. 2010 Nov;24(11):2903. doi: 10.1007/s00464-010-1073-3. Epub 2010 Apr 29.

    PMID: 20428893BACKGROUND

  • 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: 17703382BACKGROUND

  • 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: 20354937BACKGROUND

  • 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: 22068665BACKGROUND

  • 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: 21996484BACKGROUND

  • Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.

    PMID: 21561346BACKGROUND

  • ZHOU PH, CAI MY, YAO LQ, ZHONG YS, REN Z, XU MD, CHEN WF, QIN XY. [Peroral endoscopic myotomy for esophageal achalasia: report of 42 cases]. Zhonghua Wei Chang Wai Ke Za Zhi. 2011 Sep;14(9):705-8. Chinese.

    PMID: 21948538BACKGROUND

  • Smith CD, Stival A, Howell DL, Swafford V. Endoscopic therapy for achalasia before Heller myotomy results in worse outcomes than heller myotomy alone. Ann Surg. 2006 May;243(5):579-84; discussion 584-6. doi: 10.1097/01.sla.0000217524.75529.2d.

    PMID: 16632991BACKGROUND

  • Hugova K, Mares J, Hakanson B, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Ruppenthal T, Mann O, Izbicki J, Harustiak T, Fumagalli Romario U, Rosati R, Germer CT, Schijven M, Emmermann A, von Renteln D, Dautel S, Fockens P, Boeckxstaens G, Rosch T, Martinek J, Werner YB. Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 May;10(5):431-441. doi: 10.1016/S2468-1253(25)00012-3. Epub 2025 Mar 17.

    PMID: 40112837DERIVED

  • Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380.

    PMID: 31800987DERIVED

MeSH Terms

Conditions

Esophageal AchalasiaDeglutition Disorders

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Officials

  • Thomas Roesch, Prof.

    Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, Germany

    STUDY DIRECTOR

  • Paul Fockens, Prof.

    Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; Netherlands

    PRINCIPAL INVESTIGATOR

  • Bengt Håkanson, Prof.

    Department of Surgery, Karolinska University Hospital, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Guy Boeckxstaens, Prof.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • C.T. Germer, Prof.

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

  • Riccardo Repici, Prof.

    Istituto Clinico Humanitas, Rozzano, Italy

    PRINCIPAL INVESTIGATOR

  • Uberto Fumagalli, Prof.

    Istituto Clinico Humanitas, Rozzano, Italy

    PRINCIPAL INVESTIGATOR

  • Julius Spicak, Prof.

    University Hospital Prague, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

  • Helmut Messmann, Prof.

    Department for Internal Medicine III, Klinikum Augsburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 18, 2012

Study Start

December 1, 2012

Primary Completion

May 30, 2022

Study Completion

May 30, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)BE(1)NL(1)DE(3)SE(1)CZ(1)