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

NCT ID: NCT04813029

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-30

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 (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.

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).

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Straight Leg Raise

Patients perform straight leg raise maneuver at the end of High-resolution Manometry test

Group Type: EXPERIMENTAL

Straight leg raise maneuver

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

University Hospital Padova

OTHER

Sponsor Role: collaborator

University of Missouri, St. Louis

OTHER

Sponsor Role: collaborator

Hospital Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

The Oregon Clinic

OTHER

Sponsor Role: collaborator

The Functional Gut Clinic

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

Jikei University School of Medicine

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Luigi Bonavina

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luigi Bonavina, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Siboni, MD

Role: CONTACT

stefano.siboni@grupposandonato.it

+393493232750

Facility Contacts

Stefano Siboni

Role: primary

stefano.siboni@grupposandonato.it

+393493232750

References

Rogers BD, Rengarajan A, Ali IA, Hasak SL, Hansalia V, Gyawali CP. Straight leg raise metrics on high-resolution manometry associate with esophageal reflux burden. Neurogastroenterol Motil. 2020 Dec;32(12):e13929. doi: 10.1111/nmo.13929. Epub 2020 Jul 6.

Reference Type: BACKGROUND

PMID: 32633016 (View on PubMed)

Masuda T, Mittal SK, Kovacs B, Csucska M, Bremner RM. Simple Manometric Index for Comprehensive Esophagogastric Junction Barrier Competency Against Gastroesophageal Reflux. J Am Coll Surg. 2020 May;230(5):744-755e3. doi: 10.1016/j.jamcollsurg.2020.01.034. Epub 2020 Mar 3.

Reference Type: BACKGROUND

PMID: 32142925 (View on PubMed)

Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058.

Reference Type: BACKGROUND

PMID: 33373111 (View on PubMed)

Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.

Reference Type: BACKGROUND

PMID: 29437910 (View on PubMed)

van Hoeij FB, Smout AJ, Bredenoord AJ. Predictive value of routine esophageal high-resolution manometry for gastro-esophageal reflux disease. Neurogastroenterol Motil. 2015 Jul;27(7):963-70. doi: 10.1111/nmo.12570. Epub 2015 Apr 30.

Reference Type: BACKGROUND

PMID: 25930019 (View on PubMed)

Siboni S, Kristo I, Rogers BD, De Bortoli N, Hobson A, Louie B, Lee YY, Tee V, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy M, Greenan G, Facchini C, Masuda T, Yano F, Perry K, Balasubramanian G, Theodorou D, Triantafyllou T, Cusmai L, Boveri S, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19.

Reference Type: DERIVED

PMID: 36270615 (View on PubMed)

Other Identifiers

SLR2021

Identifier Type: -

Identifier Source: org_study_id