NCT04813029

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

Status unknown NA Last updated 22 July 2021

What this trial tests

NA trial testing Straight leg raise maneuver in Gastroesophageal Reflux in 336 participants. Status unknown.

Timeline

1 June 2021

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	University of Milan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	336
Start date	1 June 2021
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Straight leg raise maneuver

Conditions studied

• Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →

Sponsor

University of Milan

Who can join

Adults 18 to 75, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study.
   Siboni S, Kristo I, Rogers BD, De Bortoli N, et al · · 2023 · cited 24× · PMID 36270615 · DOI 10.1016/j.cgh.2022.10.008