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

NCT03904004 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-04-10

No results posted yet for this study

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

Interventions

PROCEDURE

Peroral endoscopic myotomy

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

PROCEDURE

Neumatic dilatation

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

PROCEDURE

Botulinum toxin injection

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

PROCEDURE

Laparoscopic Heller Myotomy

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.

Sponsors & Collaborators

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Fermin Estremera-Arevalo, MD, PhD · Complejo Hospitalario de Navarra

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2020-05-31
Completion
2022-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904004 on ClinicalTrials.gov