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

NCT04813029 | Unknown

• 1 other identifier: SLR2021
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

High Resolution Manometry; pH-impedance; Gastroesophageal Reflux disease

Outcome Measures

Primary Outcomes (2)

• Peak esophageal pressure during SLR

  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

  Mean esophageal pressure during straight leg raise maneuver, measured 5 cm above the lower esophageal sphincter

  Through study completion, an average of 6 months

Study Arms (1)

Straight Leg Raise

EXPERIMENTAL

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

Procedure: Straight leg raise maneuver

Interventions

Straight leg raise maneuver 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.

Straight Leg Raise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 32633016 BACKGROUND

• 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.

  PMID: 32142925 BACKGROUND

• 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.

  PMID: 33373111 BACKGROUND

• 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.

  PMID: 29437910 BACKGROUND

• 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.

  PMID: 25930019 BACKGROUND

• 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.

  PMID: 36270615 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Luigi Bonavina, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Siboni, MD

CONTACT

+393493232750; stefano.siboni@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: June 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)