Gastro-intestinal Physiology After Anti-Reflux Procedures

NCT05238636 | Unknown

• 2 other identifiers: 2021.0212296193
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-oesophageal reflux disease (GORD) affects 1 in 4 adults and is a condition where stomach acid leaks back up into the oesophagus (gullet). It can cause an uncomfortable burning feeling in the chest and even lead to problems such as cancer of the oesophagus. Thankfully most people feel better by changing their diet or taking medications, but for others it can be severe, and they may need to consider having surgery to tighten the internal muscles and stop acid leaking back up. The most common operation is the "laparoscopic fundoplication", which is a keyhole procedure where the top of the stomach is wrapped around the lower oesophagus. Alternatively, the "LINX device" is a keyhole procedure where a magnetic bracelet is placed around the lower oesophagus. The "Stretta procedure" is a non-surgical option, where a probe is placed in the mouth to the oesophagus, where heat energy is applied to strengthen the muscles. All three procedures have been shown to be effective at helping people feel better, but less is known about how exactly they do this and there are not many studies that have been done to compare these procedures. This study will perform tests on adult patients at St George's University Hospitals NHS Foundation Trust before and again 6 months after their surgery (laparoscopic fundoplication, LINX device or Stretta procedure). The tests are safe and are mostly performed in routine care. The tests will analyse how surgery affects:

• the strength of the oesophagus muscles
• the amount of acid leaking up
• how sensitive the oesophagus is to acid
• symptoms This should help lead to a better understanding of what changes are important to make people feel better from GORD and help inform treatment decisions with patients in future.

Conditions

Gastroesophageal Reflux

Keywords

Stretta; Laparoscopic fundoplication; LINX

Outcome Measures

Primary Outcomes (6)

• Lower oesophageal sphincter (LOS) pressure

  Measured in mm Hg with high resolution oesophageal manometry

  Before and again 6 months after anti-reflux surgery

• Gastro-oesophageal junction (GOJ) distensibility index

  EndoFLIP will be performed to calculate teh GOJ-distensibility index (DI) by dividing the median GOJ-midline cross-sectional area (CSA) by the median intra-balloon pressure over the duration of the 60mL distension, in mm2/mmHg.

  Before and again 6 months after anti-reflux surgery

• Oesophageal acid exposure

  24hour ambulatory pH monitoring and 96hour BRAVO capsule placement used to calculate % of time lower oesophageal pH is \< 4 (normal is \<6%)

  Before and again 6 months after anti-reflux surgery

• Oesophageal sensitivity to acid

  Measured with Bernstein test (0.1M hydrochloric acid oesophageal perfusion) as time (min) to reproduce symptoms of GORD

  Before and again 6 months after anti-reflux surgery

• Oesophageal biopsies

  Immunohistochemistry to measure the density of calcitonic related gene peptide (CRGP)

  Before and again 6 months after anti-reflux surgery

• Symptoms

  Hull Airway Reflux Questionnaire (HARQ), Reflux Symptom Index (RSI), Hospital Odynophagia and Dysphagia Questionnaire (HODQ), Reflux Disease Questionnaire (RDQ), Epworth Sleepiness Scale, and GERD-HRQL symptom questionnaires to grade symptoms

  Before and again 6 months after anti-reflux surgery

Study Arms (3)

Stretta

Patients that have undergone or are to undergo the Stretta procedure

Procedure: Anti-reflux surgery - Stretta procedure or LINX device or laparoscopic fundoplication

LINX

Patients that have undergone or are to undergo the LINX device

Procedure: Anti-reflux surgery - Stretta procedure or LINX device or laparoscopic fundoplication

Laparoscopic fundoplication

Patients that have undergone or are to undergo laparoscopic fundoplication.

Procedure: Anti-reflux surgery - Stretta procedure or LINX device or laparoscopic fundoplication

Interventions

Anti-reflux surgery - Stretta procedure or LINX device or laparoscopic fundoplication PROCEDURE

This is an observational study. Patients will choose which anti-reflux procedure (Stretta, LINX or fundoplication) they undergo with their clinician, as is standard practice, after which they will be offered recruitment to this study, which will perform investigations to assess for changes in physiology and symptoms.

LINX; Laparoscopic fundoplication; Stretta

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients at St George's University Hospitals NHS Foundation Trust, who have been listed for Stretta procedure, LINX device or laparoscopic fundoplication for GORD.

You may qualify if:

• Patient under the care of St George's University Hospital NHS Foundation Trust, London
• Decision to specifically undergo Stretta procedure, laparoscopic fundoplication or LINX device (N.B. this study will have no involvement in that decision or choice of procedure)
• Symptoms compatible with GORD, e.g. heartburn, regurgitation, chest pain
• Physiological evidence of GORD, e.g. endoscopy, HRM, pH studies
• Male or Female
• Age 18 to 90

You may not qualify if:

• Patients \< 18 years old or \>90 years old
• Patients with significant medical co-morbidities
• Patients unable to provide consent for study participation
• Patients unable to easily attend hospital for the physiological tests
• Patients who have had complications from their anti-reflux procedure
• Patients who have previously undergone oesophageal surgery

Sponsors & Collaborators

• St George's, University of London: lead
• Wingate Institute of Neurogastroenterology: collaborator

Study Sites (1)

St Georges University Hospitals NHS Foundation Trust

London, SW17 0RE, United Kingdom

RECRUITING

Related Publications (9)

• Frazzoni M, Piccoli M, Conigliaro R, Frazzoni L, Melotti G. Laparoscopic fundoplication for gastroesophageal reflux disease. World J Gastroenterol. 2014 Oct 21;20(39):14272-9. doi: 10.3748/wjg.v20.i39.14272.

  PMID: 25339814 BACKGROUND

• Schizas D, Mastoraki A, Papoutsi E, Giannakoulis VG, Kanavidis P, Tsilimigras D, Ntourakis D, Lyros O, Liakakos T, Moris D. LINX(R) reflux management system to bridge the "treatment gap" in gastroesophageal reflux disease: A systematic review of 35 studies. World J Clin Cases. 2020 Jan 26;8(2):294-305. doi: 10.12998/wjcc.v8.i2.294.

  PMID: 32047777 BACKGROUND

• Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730.

  PMID: 24976710 BACKGROUND

• Trudgill NJ, Sifrim D, Sweis R, Fullard M, Basu K, McCord M, Booth M, Hayman J, Boeckxstaens G, Johnston BT, Ager N, De Caestecker J. British Society of Gastroenterology guidelines for oesophageal manometry and oesophageal reflux monitoring. Gut. 2019 Oct;68(10):1731-1750. doi: 10.1136/gutjnl-2018-318115. Epub 2019 Jul 31.

  PMID: 31366456 BACKGROUND

• Desprez C, Roman S, Leroi AM, Gourcerol G. The use of impedance planimetry (Endoscopic Functional Lumen Imaging Probe, EndoFLIP(R) ) in the gastrointestinal tract: A systematic review. Neurogastroenterol Motil. 2020 Sep;32(9):e13980. doi: 10.1111/nmo.13980.

  PMID: 32856765 BACKGROUND

• BERNSTEIN LM, BAKER LA. A clinical test for esophagitis. Gastroenterology. 1958 May;34(5):760-81. No abstract available.

  PMID: 13538145 BACKGROUND

• Sawada A, Lei WY, Zhang M, Lee C, Ustaoglu A, Chen CL, Sifrim D. Esophageal mucosal sensory nerves and potential mechanoreceptors in patients with ineffective esophageal motility. Neurogastroenterol Motil. 2022 Feb;34(2):e14205. doi: 10.1111/nmo.14205. Epub 2021 Jun 21.

  PMID: 34152070 BACKGROUND

• Lawenko RM, Lee YY. Evaluation of Gastroesophageal Reflux Disease Using the Bravo Capsule pH System. J Neurogastroenterol Motil. 2016 Jan 31;22(1):25-30. doi: 10.5056/jnm15151.

  PMID: 26717929 BACKGROUND

• Chan Y, Ching JY, Cheung CM, Tsoi KK, Polder-Verkiel S, Pang SH, Quan WL, Kee KM, Chan FK, Sung JJ, Wu JC. Development and validation of a disease-specific quality of life questionnaire for gastro-oesophageal reflux disease: the GERD-QOL questionnaire. Aliment Pharmacol Ther. 2010 Feb 1;31(3):452-60. doi: 10.1111/j.1365-2036.2009.04187.x. Epub 2009 Oct 31.

  PMID: 19878152 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

4-6 oesophageal mucosal biopsies will be taken during endoscopy using standard 2.8 millimetre gastroscopy biopsy forceps and placed into formalin solution then stored in a medical freezer at St George's Hospital. They will then be couriered on dry ice to the Wingate Institute of Neurogastroenterology, where they will undergo immunohistochemical analysis, after which they will be disposed of by standard practices.

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Jamal Hayat

  St George's University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

• Joseph Cooney

  St George's University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Cooney

CONTACT

02087254986; joseph.cooney@nhs.net

Rosie Jacobs

CONTACT

02087254986; researchgovernance@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 14, 2022
• Study Start: May 12, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 20, 2024
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)