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

April 8, 2019 updated by: Fundacion Miguel Servet

Impact of Peroral Endoscopic Myotomy and Other Treatments for Oesophageal Motility Disorders on Bolus Transport and Gastro-oesophageal Reflux. The pFlow Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Methods This is an international multicenter prospective observational study in a cohort of individuals affected by an oesophageal motor disorder (OMD).

Participating centers OMD are treated in most tertiary hospitals surgically (Laparoscopic Heller Myotomy (LHM)) or endoscopically (botulinic toxin injection, pneumatic dilatation or peroral endoscopic myotomy (POEM)). The main requirement is to perform high-resolution manometry with impedance before and after the procedure.

Subjects Inclusion criteria are to present with gastrointestinal (GI) symptoms that are secondary to OMD such as dysphagia, regurgitation and/or non-cardiac chest pain. OMD under study are achalasia type I, II and III; oesophagogastric junction (OGJ) outflow obstruction; distal oesophageal spasm, hypercontractile oesophagus or disorders not fulfilling Chicago Criteria version 3. Treatments included are outlined in the previous paragraph.

Exclusion criteria are the inability to fill in symptom questionnaires, intolerance of pre or postprocedure test, incomplete therapeutic procedures or artifacts in manometry/impedance tracings.

Data sharing High-resolution manometry (HRM)-impedance studies will be shared and PF analysis will be performed through Swallow Gateway®. See Appendix 1 for further detail. An acrobat sheet will be eased to fill-in symptomatic and test data pre and post-procedure. It will also be shared through Swallowgateway®.

Variables

  1. Demographics: age, sex, anesthetic risk assessment (ASA), height and weight, proton pump inhibitors (PPI) intake.

  2. Previous treatments:

    1. Type of treatment.
    2. Number of previous treatments.
    3. Years before current treatment.
  3. Symptoms: time from symptoms onset, dysphagia scores (Eckardt, Mellow-Pinkas), gastro-esophageal reflux score questionnaire (GERD-Q), heartburn and regurgitation visual analogic score (VAS), quality of life score short form 12 (SF-12).

  4. Pre and post-operative test:

    1. Endoscopy: sigmoid oesophageal dilatation, solid/liquid oesophageal remanent, difficulty to progress through OGJ, oesophagitis (Los Angeles score).
    2. Barium swallow: oesophageal diameter [grade I (< 3.5 cm), grade II (3.5-6 cm) and grade III (> 6 cm)]14, barium column height at 1 and 5 min post-swallowing.
    3. High-resolution manometry: equipment specification (probe, system), morphologic classification of the OGJ, end-expiratory basal pressure, 4 second integrated relaxation pressure (4s-IRP), mean distal contractile integrity (DCI), percentage of failed swallows (DCI<100 mmHg-cm-s), distal latency (DL), percentage of swallows with distal oesophagus pressurization > 30 mmHg, percentage of swallows with pan oesophageal pressurization, type of peristalsis after rapid swallow test, pan oesophageal pressurization after multiple swallow test. Chicago v3 diagnosis of motility pattern.

  5. Procedure variables:

    a. Botulinic toxine: i. International units (IU) delivered. ii. Number of toxine injection sessions. iii. Region of oesophagus where the toxin is injected. iv. Complications description, severity and management*. b. Pneumatic dilatation: i. Size of the balloon. ii. Number of dilatations. iii. Complications description, severity and management *. iv. In-hospital stay length**. c. POEM: i. Number of POEM performed by the endoscopist. ii. Anterior or posterior approach. iii. Oesophageal tunnel length. iv. Gastric tunnel length. v. Oesophageal myotomy length. vi. Gastric myotomy length. vii. Full-thickness or partial myotomy. viii. Duration of the procedure. ix. Complications description, severity and management *. x. In-hospital stay length**. d. Laparoscopic Heller Myotomy: i. Number of LHM performed by the surgeon. ii. Oesophageal myotomy length. iii. Gastric myotomy length. iv. Duration of the procedure. v. Complications description, severity and management*. vi. In-hospital stay length**.

  6. Pre and post-operative pressure-flow analysis in HRM-impedance:

    - HRM-impedance protocol: patient preparation and HRIM catheter insertion are recommended as described previously (see references) in a recumbent and an inclination of 0 to 30 degrees of head elevation. After positioning of the probe sensors and a 5-min rest period, swallow-induced peristalsis will be tested at 30s intervals. Ten 5-mL liquid swallows (0.9% saline) will be delivered. Peristalsis recovery (weak or normal peristalsis in > 1 swallow with normal DL).

    a. Three measures of intra-bolus distension pressures (DP) during bolus transport were determined at nadir impedance7. These pressures were i. DP bolus accommodation (DPA), intra-bolus distension pressure recorded between the upper oesophageal sphincter (UOS) and the transition zone (TZ); ii. DP compartmentalized transport (DPCT), intra-bolus distension pressure recorded between the TZ and the contractile deceleration point, (CDP); and iii. DP during oesophageal emptying (DPE), intra-bolus distension pressure recorded between the CDP and crural diaphragm (CD).

    b. Bolus clearance from the oesophagus was determined by the impedance ratio (IR = oesophageal nadir impedance divided by impedance recorded during contractile peak pressure). Higher IR indicates less effective oesophageal clearance16.

    c. Two measures of bolus flow latencies, determined at the CDP level, were i. swallow initiation to maximal bolus distension latency (SDL) and ii. maximal bolus distension to contraction latency (DCL). d. Pressures generated during bolus clearance (or clearance pressures) were measured within the distal oesophagus. The closure pressure (CP) was the pressure at luminal closure and the rate of ramp pressure (RP) was the mean gradient of pressure during closure. Timing of luminal closure was taken as when impedance had recovered 50 %, a validated criterion in widespread use17.

    e. A pressure-flow index (PFI) composite score was derived using the following formula: PFI = (DPE*RP)/DCL i.e. the distal IBP during the phase of oeosphageal emptying multiplied by the rate of ramp pressure rise, divided by the time interval from bolus distension to contraction latency.

    f. Bolus presence time (BPT) was estimated based on the method of Lin within the 2 cm segment above the CD landmark.

    g. Trans-OGJ bolus flow time (BFT) was calculated also according to the method of Lin, recording the time deemed favourable for bolus flow across the OGJ.

  7. 24h pH/impedance testing.

    • Following American Society for gastrointestinal endoscopy (ASGE) lexicon. **Days after finishing the procedure.

Analysis Main outcome

1. Compare the modification of PF variables between the type of treatment groups for the same OMD.

Secondary outcomes

  1. Comparison of pre-procedure PF variables within patients diagnosed with the same manometric subtype.
  2. Correlation of PF variables before and after treatment with the respective symptoms.
  3. Comparison of post-procedure PF variables between patients with clinical success and clinical failure.
  4. Correlation of post-procedure PF variables with barium column.
  5. Comparison of post-procedure PF variables between patients with and without post-procedure GOR.
  6. Correlation of post-procedure PF variables with grade of Los Angeles oesophagitis classification, % of distal oesophageal acid exposure time and deMeester score.

Visits protocol Visit 1 - at pre-procedure HRM impedance

  • Delivery of informed consent.
  • Demographic and symptomatic data interrogation.
  • Gather endoscopy and barium swallow data.
  • HRM impedance testing.
  • Procedure choice and explanation. Visit 2 - at hospital discharge
  • Procedure-related variables.
  • Complications.
  • In-hospital stay length. Visit 3 - 3 to 6 months post-procedure
  • Symptom-related data.
  • Endoscopy and barium swallow data.
  • HRM impedance testing.
  • 24h pH/impedance testing.
  • Data sharing through Swallow Gateway®. Visit 4 - 1 year post-procedure
  • Symptomatic data interrogation

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
        • Contact:
        • Principal Investigator:
          • Fermin Estremera-Arevalo, MD PhD
        • Principal Investigator:
          • EDUARDO ALBENIZ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria are the inability to fill in symptom questionnaires, intolerance of pre or post procedure test, incomplete therapeutic procedures or technical failure of baseline manometry investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Esophageal motility disorders
Individuals with sympmtoms related to esophageal motility disorders who receive a endoscopic or surgical treatment
Procedure: Peroral endoscopic myotomy
Endoscopic myotomy after performing a tunnel to reach the muscular layer through a mucosal incision
Other Names:
  • POEM
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
Other Names:
  • Botox
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bolus Pressure and Flow (PF) modification
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PF analysis within similar OMD
Time Frame: 6 months
Compare PF variables (as described in Outcome 1) within the same OMD at the moment previously to the treatment.
6 months
Symptom correlation
Time Frame: 12 months
Correlate PF variables with pre and post-treatment symptoms of dysphagia, chest pain, regurgitation and heartburn symptom scoring.
12 months
Clinical success correlation
Time Frame: 12 months
Identify PF variables that may be predictors with clinical success and failure as described in the symptom scoring tests.
12 months
Correlation with barium column
Time Frame: 6 months
Identify PF variables that are predictors of timed barium column as a surrogate of prognosis
6 months
Correlation with reflux
Time Frame: 6 months
Identify PF variables that are predictors of post-procedure gastro-oesophageal reflux (GOR) diagnosis after endoscopy - regarding oesophagitis- and 24h pH test -regarding percentage of distal oesophagus acid exposure and deMeester score.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Principal Investigator: Fermin Estremera-Arevalo, MD, PhD, Complejo Hospitalario de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EST-ALB-pFlow

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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