Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04813029
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-03-17
Brief Title:
Thresholds of Straight Leg Raise Maneuver During High-Resolution-Manometry
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Defining High-Resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver Predictive of Pathologic Acid Exposure Time
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 536 and 725 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
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
Detailed Description:
It has been demonstrated a low sensitivity and specificity of HRM for GERD 536 and 725 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 40 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
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 40 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None