Short Vs Standard Length Myotomy in Achalasia

NCT04798547 | Completed

• 1 other identifier: STU00212053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy

  At 1, 6 and 12 months, patient reported outcome of achalasia symptoms will be assessed. The Eckardt Score is a validated research tool for achalasia symptoms. Scores range from 0-12. A higher score indicates worse symptoms. We will compare Eckardt Score pre-POEM and post-PEM at various time points.

  2 years

Secondary Outcomes (3)

• Compare procedure complications after 4 cm myotomy with POEM compared to 8 cm myotomy with POEM

  1 year

• Compare procedural time and intra-procedural findings between 4 cm myotomy with POEM compared to 8 cm myotomy with POEM

  1 year

• Compare post-POEM gastro-esophageal reflux between 4 cm myotomy and 8 cm myotomy using GERDQ assessment.

  2 years

Study Arms (2)

Standard Length Myotomy

PLACEBO COMPARATOR

Patients randomized to received 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia

Procedure: Standard Length Myotomy

Short Length Myotomy

EXPERIMENTAL

Patients randomized to received 4 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia

Procedure: Short Myotomy

Interventions

Short Myotomy PROCEDURE

Evaluation of short length myotomy

Short Length Myotomy

Standard Length Myotomy PROCEDURE

Standard Length Myotomy

Standard Length Myotomy

Eligibility Criteria

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

You may qualify if:

• All patients aged 18+ diagnosed with Type I or Type II achalasia, and patients with EGJ Outflow Obstruction with features of achalasia based on HRM or Endoscopic Functional Lumen Imaging Probe (EndoFLIP)
• All subjects must have given signed, informed consent prior to registration in the study

You may not qualify if:

• Patient with Type III achalasia or spastic esophageal dysmotility disorders requiring long myotomy as determined by HRM
• All patients who are unable or unwilling to give consent will not be included in the study
• Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 50,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
• Patients who have already undergone treatment with POEM or Heller Myotomy

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (14)

• Chen WF, Li QL, Zhou PH, Yao LQ, Xu MD, Zhang YQ, Zhong YS, Ma LL, Qin WZ, Hu JW, Cai MY, He MJ, Cui Z. Long-term outcomes of peroral endoscopic myotomy for achalasia in pediatric patients: a prospective, single-center study. Gastrointest Endosc. 2015 Jan;81(1):91-100. doi: 10.1016/j.gie.2014.06.035. Epub 2014 Aug 1.

  PMID: 25088923 RESULT

• Hungness ES, Sternbach JM, Teitelbaum EN, Kahrilas PJ, Pandolfino JE, Soper NJ. Per-oral Endoscopic Myotomy (POEM) After the Learning Curve: Durable Long-term Results With a Low Complication Rate. Ann Surg. 2016 Sep;264(3):508-17. doi: 10.1097/SLA.0000000000001870.

  PMID: 27513156 RESULT

• Laurino-Neto RM, Herbella F, Schlottmann F, Patti M. EVALUATION OF ESOPHAGEAL ACHALASIA: FROM SYMPTOMS TO THE CHICAGO CLASSIFICATION. Arq Bras Cir Dig. 2018;31(2):e1376. doi: 10.1590/0102-672020180001e1376. Epub 2018 Jul 2.

  PMID: 29972404 RESULT

• Taft TH, Carlson DA, Triggs J, Craft J, Starkey K, Yadlapati R, Gregory D, Pandolfino JE. Evaluating the reliability and construct validity of the Eckardt symptom score as a measure of achalasia severity. Neurogastroenterol Motil. 2018 Jun;30(6):e13287. doi: 10.1111/nmo.13287. Epub 2018 Jan 8.

  PMID: 29315993 RESULT

• Kahrilas PJ, Boeckxstaens G. The spectrum of achalasia: lessons from studies of pathophysiology and high-resolution manometry. Gastroenterology. 2013 Nov;145(5):954-65. doi: 10.1053/j.gastro.2013.08.038. Epub 2013 Aug 21.

  PMID: 23973923 RESULT

• Boeckxstaens GE, Zaninotto G, Richter JE. Achalasia. Lancet. 2014 Jan 4;383(9911):83-93. doi: 10.1016/S0140-6736(13)60651-0. Epub 2013 Jul 17.

  PMID: 23871090 RESULT

• Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.

  PMID: 18722376 RESULT

• Spechler SJ, Castell DO. Classification of oesophageal motility abnormalities. Gut. 2001 Jul;49(1):145-51. doi: 10.1136/gut.49.1.145.

  PMID: 11413123 RESULT

• Pandolfino JE, Kahrilas PJ; American Gastroenterological Association. AGA technical review on the clinical use of esophageal manometry. Gastroenterology. 2005 Jan;128(1):209-24. doi: 10.1053/j.gastro.2004.11.008. No abstract available.

  PMID: 15633138 RESULT

• Kahrilas PJ, Katzka D, Richter JE. Clinical Practice Update: The Use of Per-Oral Endoscopic Myotomy in Achalasia: Expert Review and Best Practice Advice From the AGA Institute. Gastroenterology. 2017 Nov;153(5):1205-1211. doi: 10.1053/j.gastro.2017.10.001. Epub 2017 Oct 6.

  PMID: 28989059 RESULT

• Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.

  PMID: 25469569 RESULT

• 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 RESULT

• Kane ED, Budhraja V, Desilets DJ, Romanelli JR. Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia. Surg Endosc. 2019 Mar;33(3):886-894. doi: 10.1007/s00464-018-6356-0. Epub 2018 Jul 27.

  PMID: 30054739 RESULT

• Li QL, Chen WF, Zhou PH, Yao LQ, Xu MD, Hu JW, Cai MY, Zhang YQ, Qin WZ, Ren Z. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg. 2013 Sep;217(3):442-51. doi: 10.1016/j.jamcollsurg.2013.04.033. Epub 2013 Jul 25.

  PMID: 23891074 RESULT

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: March 15, 2021
• Study Start: June 1, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)