Gastroesophageal Reflux Clinical Trial
— GASPOfficial title:
The Effect of Anti-reflux Procedures (Stretta, LINX, and Fundoplication) on Physiological Parameters Contributing to Symptom Resolution in Adults With Gastro-oesophageal Reflux at a Single UK Tertiary Centre
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 20, 2024 |
Est. primary completion date | January 10, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Georges University Hospitals NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | Wingate Institute of Neurogastroenterology |
United Kingdom,
BERNSTEIN LM, BAKER LA. A clinical test for esophagitis. Gastroenterology. 1958 May;34(5):760-81. No abstract available. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower oesophageal sphincter (LOS) pressure | Measured in mm Hg with high resolution oesophageal manometry | Before and again 6 months after anti-reflux surgery | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Oesophageal biopsies | Immunohistochemistry to measure the density of calcitonic related gene peptide (CRGP) | Before and again 6 months after anti-reflux surgery | |
Primary | 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 |
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