Thresholds of Straight Leg Raise Maneuver During High-Resolution-Manometry

July 15, 2021 updated by: Luigi Bonavina, University of Milan

Defining High-Resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver Predictive of Pathologic Acid Exposure Time

High resolution manometry (HRM) is a key test in the preoperative assessment of patients with gastro-esophageal reflux disease (GERD) who are potential candidates for antireflux surgery. The recent Lyon consensus suggested the potential usefulness of HRM in diagnosing GERD, however, sensitivity and specificity of HRM for GERD remains low (53.6% and 72.5% respectively). Among recently proposed provocative tests during manometry, a traditional maneuver (straight leg raise maneuver, SLR) appeared promising in predicting reflux.

This is a multicenter study involving high-volume esophageal function laboratories around the world. Patients with suspected GERD and tested with HRM and pH-impedance will be asked to perform SLR during HRM. Intra-abdominal and intra-esophageal pressure during SLR will be recorded and compared with acid exposure time (AET) at pH-impedance.

Primary aim is to determine the optimal threshold of intra-esophageal pressure augmentation during straight leg raise (SLR) maneuver that predicts pathological esophageal acid exposure time (AET). Secondary aim is to assess the diagnostic performance of HMR with SRL maneuver, calculating sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), positive predictive value and total misclassification rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It has been demonstrated a low sensitivity and specificity of HRM for GERD (53.6% and 72.5% respectively), since there was a significant overlap between patients and controls in the majority of parameters. Masuda et al. attempted to improve HRM accuracy using a comprehensive index and new parameters, such as the backflow preventive and promotive pressure through the lower esophageal sphincter (LES). Although a significant correlation between reflux burden and the new index was found, sensitivity and specificity of HRM for GERD remained unchanged.

Recently, provocative tests have been added to the standard protocol of HRM studies. Among these, a traditional maneuver in water perfused manometry (straight leg raise maneuver, SLR) appeared promising in predicting reflux even with HRM.

A multicenter study with a large number of patients could provide more precise thresholds to predict pathologic esophageal acid exposure time and proof of real-life generalizability of SLR.

A thorough clinical evaluation will be performed. GerdQ, GERD Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires will be administered. HRM will be performed according to the standard protocol defined by Chicago Classification 4.0. Upon completion of the test, the SLR maneuver will be performed. With the patient in supine position, one leg is raised to form an angle of at least 45 degrees with the bed. The patient will be asked to keep that position for at least 5 seconds. The maneuver will be repeated after 20-30 seconds. The first adequate maneuver will be considered for the study. Intra-esophageal and intra-abdominal pressure will be analyzed both during baseline and SLR maneuver. Intra-esophageal pressure is measured as peak and mean over 5 seconds, 1 cm and 5 cm above the proximal margin of the LES. Intra-abdominal pressure will be measured as peak and mean over 5 seconds 1 cm below the distal margin of the diaphragm notch.

Primary aim is to determine the optimal threshold of intra-esophageal pressure augmentation during straight leg raise (SLR) maneuver that predicted pathological esophageal acid exposure time (AET). Secondary aim is to assess the diagnostic performance of HMR with SRL maneuver in patients with GERD symptoms, calculating sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR) and total misclassification rate.

The Principal Investigator will maintain research data on an encrypted file server with access controls only accessible to approved study investigators. Research records will be de-identified using coded subject identifiers prior to transfer from sites to the Principal Investigator to protect patient confidentiality. Study data will be maintained by the Principal Investigator and deleted 3 years after the end of the study.

Data from each site will be electronically transferred to Principal Investigator. The electronic copy will contain no patient identifying data elements such as name, date of birth, medical record numbers. Participating institutions will create unique patient participant numbers based on a standard formula allocated by Principal investigator (two digit institution code, two digit patient identifier, 01-20).

Study Type

Interventional

Enrollment (Anticipated)

336

Phase

  • Not Applicable

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

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
        • Principal Investigator:
          • Luigi Bonavina, MD
        • Sub-Investigator:
          • Stefano Siboni, MD
        • Sub-Investigator:
          • Erika Andreatta, 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete and adequate HRM and pH-impedance study performed within 2 weeks
  • Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)

Exclusion Criteria:

  • Patients with prior foregut surgery
  • Obese with BMI>35 Kg/m2
  • Paraesophageal hiatal hernia
  • Scleroderma
  • Eosinophilic esophagitis

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Straight Leg Raise
Patients perform straight leg raise maneuver at the end of High-resolution Manometry test
Procedure: Straight leg raise maneuver
With the patient in supine position, one leg is raised to form an angle of at least 45 degrees with the bed. The patient will be asked to keep that position for at least 5 seconds. The maneuver will be repeated after 20-30 seconds. The first adequate maneuver will be considered for the study. Intra-esophageal and intra-abdominal pressure will be analyzed both during baseline and SLR maneuver. Intra-esophageal pressure is measured as peak and mean over 5 seconds, 1 cm and 5 cm above the proximal margin of the LES. Intra-abdominal pressure will be measured as peak and mean over 5 seconds 1 cm below the distal margin of the diaphragm notch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak esophageal pressure during SLR
Time Frame: Through study completion, an average of 6 months
Peak esophageal pressure during straight leg raise maneuver, measured 5 cm above the lower esophageal sphincter
Through study completion, an average of 6 months
Mean esophageal pressure during SLR
Time Frame: Through study completion, an average of 6 months
Mean esophageal pressure during straight leg raise maneuver, measured 5 cm above the lower esophageal sphincter
Through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

University of Milan

Collaborators

Medical University of Vienna
Ohio State University
University of Campania "Luigi Vanvitelli"
University of Athens
Hospital Universiti Sains Malaysia
University of Texas at Austin
The Functional Gut Clinic
University Hospital Padova
Jikei University School of Medicine
The Oregon Clinic
University of Missouri, St. Louis

Investigators

  • Principal Investigator: Luigi Bonavina, MD, University of Milan

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

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 (Actual)

June 1, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLR2021

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.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on Straight leg raise maneuver

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe