Pressure and Flow Study Before and After Treatments for EMD. The pFlow Study

NCT03904004 | Unknown

• 1 other identifier: EST-ALB-pFlow
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure and flow (PF) analysis allow a detailed report on the bolus passing for each segment of the esophagus. This approach has evidence in oropharyngeal dysphagia, post reflux surgery dysphagia, gastroesophageal reflux in infants and dysphagia in patients with normal manometry. However, it has not been used for defined esophageal motility disorders and their response to surgical or endoscopic treatments. Better knowledge about pre and postoperative bolus flow can yield important concepts that can modify the selection of optimal treatments.

Conditions

Esophageal Motility Disorders; Gastro-esophageal Reflux

Keywords

esophageal motility disorders; laparoscopic Heller myotomy; peroral endoscopic myotomy; neumatic cilatation; botulinic toxin injection; gastro esophageal reflux

Outcome Measures

Primary Outcomes (1)

• Bolus Pressure and Flow (PF) modification

  Compare oesophageal biomechanics (based on PF analysis) before and after the different surgical or endoscopic treatments for oesophageal motility disorders (OMD). This analysis describes through numeric variables the passing of the bolus from the mouth to the stomach regarding resistance of flow, clearance and velocity for every part of the oesophagus

  6 months

Secondary Outcomes (5)

• PF analysis within similar OMD

  6 months

• Symptom correlation

  12 months

• Clinical success correlation

  12 months

• Correlation with barium column

  6 months

• Correlation with reflux

  6 months

Study Arms (1)

Esophageal motility disorders

Individuals with sympmtoms related to esophageal motility disorders who receive a endoscopic or surgical treatment

Procedure: Peroral endoscopic myotomy; Procedure: Neumatic dilatation; Procedure: Botulinum toxin injection; Procedure: Laparoscopic Heller Myotomy

Interventions

Peroral endoscopic myotomy PROCEDURE

Endoscopic myotomy after performing a tunnel to reach the muscular layer through a mucosal incision

Also known as: POEM

Esophageal motility disorders

Neumatic dilatation PROCEDURE

Inflation of a ballon of specific diameter in the gastro-oesophageal junction

Esophageal motility disorders

Botulinum toxin injection PROCEDURE

Injection of botulinic toxin to inhibit the contraction of the gastro-oesophageal junction muscular layer

Also known as: Botox

Esophageal motility disorders

Laparoscopic Heller Myotomy PROCEDURE

Five or six small incisions are made in the abdominal wall and laparoscopic instruments are inserted. The myotomy is a lengthwise cut along the oesophagus, starting above the lower oesophageal sphincter (LOS) and extending down onto the stomach a little way. The oesophagus is made of several layers, and the myotomy only cuts through the outside muscle layers which are squeezing it shut, leaving the inner mucosal layer intact.

Esophageal motility disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any age and sex diagnosed with an EMD that generate symptoms

You may qualify if:

• to present with GI symptoms that are secondary to EMD such as dysphagia, regurgitation and/or non-cardiac chest pain.
• the EMD patients to be recruited under this study are achalasia type I, II and III; OGJ outflow obstruction; distal oesophageal spasm, hypercontractile oesophagus or disorders not fulfilling Chicago Criteria v3.
• Receive a treatment such as POEM, neumatic dilatation, LHM, botox injection.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (21)

• Estremera-Arevalo F, Albeniz E, Rullan M, Areste I, Iglesias R, Vila JJ. Efficacy of peroral endoscopic myotomy compared with other invasive treatment options for the different esophageal motor disorders. Rev Esp Enferm Dig. 2017 Aug;109(8):578-586. doi: 10.17235/reed.2017.4773/2016.

  PMID: 28617027 BACKGROUND

• Khashab MA, Familiari P, Draganov PV, Aridi HD, Cho JY, Ujiki M, Rio Tinto R, Louis H, Desai PN, Velanovich V, Albeniz E, Haji A, Marks J, Costamagna G, Deviere J, Perbtani Y, Hedberg M, Estremera F, Martin Del Campo LA, Yang D, Bukhari M, Brewer O, Sanaei O, Fayad L, Agarwal A, Kumbhari V, Chen YI. Peroral endoscopic myotomy is effective and safe in non-achalasia esophageal motility disorders: an international multicenter study. Endosc Int Open. 2018 Aug;6(8):E1031-E1036. doi: 10.1055/a-0625-6288. Epub 2018 Aug 10.

  PMID: 30105290 BACKGROUND

• Schlottmann F, Luckett DJ, Fine J, Shaheen NJ, Patti MG. Laparoscopic Heller Myotomy Versus Peroral Endoscopic Myotomy (POEM) for Achalasia: A Systematic Review and Meta-analysis. Ann Surg. 2018 Mar;267(3):451-460. doi: 10.1097/SLA.0000000000002311.

  PMID: 28549006 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.

  PMID: 10403727 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

• Bredenoord AJ, Hebbard GS. Technical aspects of clinical high-resolution manometry studies. Neurogastroenterol Motil. 2012 Mar;24 Suppl 1:5-10. doi: 10.1111/j.1365-2982.2011.01830.x.

  PMID: 22248102 BACKGROUND

• Imam H, Shay S, Ali A, Baker M. Bolus transit patterns in healthy subjects: a study using simultaneous impedance monitoring, videoesophagram, and esophageal manometry. Am J Physiol Gastrointest Liver Physiol. 2005 May;288(5):G1000-6. doi: 10.1152/ajpgi.00372.2004.

  PMID: 15826930 BACKGROUND

• Nguyen NQ, Holloway RH, Smout AJ, Omari TI. Automated impedance-manometry analysis detects esophageal motor dysfunction in patients who have non-obstructive dysphagia with normal manometry. Neurogastroenterol Motil. 2013 Mar;25(3):238-45, e164. doi: 10.1111/nmo.12040. Epub 2012 Oct 31.

  PMID: 23113942 RESULT

• Singendonk MM, Kritas S, Cock C, Ferris LF, McCall L, Rommel N, van Wijk MP, Benninga MA, Moore D, Omari TI. Pressure-flow characteristics of normal and disordered esophageal motor patterns. J Pediatr. 2015 Mar;166(3):690-6.e1. doi: 10.1016/j.jpeds.2014.12.002. Epub 2015 Jan 13.

  PMID: 25596103 RESULT

• Omari T, Connor F, McCall L, Ferris L, Ellison S, Hanson B, Abu-Assi R, Khurana S, Moore D. A study of dysphagia symptoms and esophageal body function in children undergoing anti-reflux surgery. United European Gastroenterol J. 2018 Jul;6(6):819-829. doi: 10.1177/2050640618764936. Epub 2018 Mar 8.

  PMID: 30023059 RESULT

• Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.

  PMID: 1451966 RESULT

• Mellow MH, Pinkas H. Endoscopic therapy for esophageal carcinoma with Nd:YAG laser: prospective evaluation of efficacy, complications, and survival. Gastrointest Endosc. 1984 Dec;30(6):334-9. doi: 10.1016/s0016-5107(84)72448-5.

  PMID: 6210226 RESULT

• Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.

  PMID: 19737151 RESULT

• Omari TI, Szczesniak MM, Maclean J, Myers JC, Rommel N, Cock C, Cook IJ. Correlation of esophageal pressure-flow analysis findings with bolus transit patterns on videofluoroscopy. Dis Esophagus. 2016 Feb-Mar;29(2):166-73. doi: 10.1111/dote.12300. Epub 2014 Dec 17.

  PMID: 25515292 RESULT

• Lin Z, Imam H, Nicodeme F, Carlson DA, Lin CY, Yim B, Kahrilas PJ, Pandolfino JE. Flow time through esophagogastric junction derived during high-resolution impedance-manometry studies: a novel parameter for assessing esophageal bolus transit. Am J Physiol Gastrointest Liver Physiol. 2014 Jul 15;307(2):G158-63. doi: 10.1152/ajpgi.00119.2014. Epub 2014 May 22.

  PMID: 24852565 RESULT

• Omari TI, Papathanasopoulos A, Dejaeger E, Wauters L, Scarpellini E, Vos R, Slootmaekers S, Seghers V, Cornelissen L, Goeleven A, Tack J, Rommel N. Reproducibility and agreement of pharyngeal automated impedance manometry with videofluoroscopy. Clin Gastroenterol Hepatol. 2011 Oct;9(10):862-7. doi: 10.1016/j.cgh.2011.05.026. Epub 2011 Jun 6.

  PMID: 21699810 RESULT

• Omari TI, Dejaeger E, Van Beckevoort D, Goeleven A, De Cock P, Hoffman I, Smet MH, Davidson GP, Tack J, Rommel N. A novel method for the nonradiological assessment of ineffective swallowing. Am J Gastroenterol. 2011 Oct;106(10):1796-802. doi: 10.1038/ajg.2011.143. Epub 2011 May 10.

  PMID: 21556039 RESULT

• Myers JC, Nguyen NQ, Jamieson GG, Van't Hek JE, Ching K, Holloway RH, Dent J, Omari TI. Susceptibility to dysphagia after fundoplication revealed by novel automated impedance manometry analysis. Neurogastroenterol Motil. 2012 Sep;24(9):812-e393. doi: 10.1111/j.1365-2982.2012.01938.x. Epub 2012 May 23.

  PMID: 22616652 RESULT

Related Links

• Online tool for sharing manometry studies and performing P\&F analysis

MeSH Terms

Conditions

Esophageal Motility Disorders; Gastroesophageal Reflux

Interventions

Botulinum Toxins; Botulinum Toxins, Type A; Heller Myotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Officials

• Fermin Estremera-Arevalo, MD, PhD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fermin Estremera-Arevalo, MD, PhD

CONTACT

+34 686255456; festremera15@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: May 15, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2022
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)