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Sponsor decided not to fund the study.
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| Name | Class |
|---|---|
| EndoGastric Solutions | INDUSTRY |
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In this research study the investigators want to learn more about the effectiveness of an endoscopic procedure (an endoscope is a lighted tube that is placed down the participants esophagus, through the participants mouth) which uses a device that allows the doctor to repair or recreate the body's natural barrier to reflux. It uses preloaded forceps (tweezers) and fasteners and requires no incision to tighten the connection between the participants esophagus and stomach. This procedure is performed to aid in the treatment of symptoms of Gastroesophageal Reflux disease (GERD) in patients with diagnosed Laryngopharyngeal reflux (LPR). LPR is a condition resulting from backflow of stomach contents into the laryngopharynx (connection point in the participants throat through which food, water, and air pass) resulting in symptoms that can be referred to larynx/hypopharynx. The device the investigators will use to perform the transoral incisionless fundoplication procedure (TIF) is called the EsophyX device. The participants have been asked to participate because they have been diagnosed with LPR and have either failed medical therapy (taking prescription proton pump inhibitors (PPI) to reduce stomach acid production or do not want to be on long-term medical treatment.
To date, more than one-third of the motility patients that the investigators see in practice at Brigham and Women's Hospital have LPR. There is currently limited literature available addressing LPR as a primary indication for the TIF procedure moreover there is no single therapy that has proved its efficacy over the years against LPR. The investigators propose a pilot study to investigate the efficacy of TIF with the EsophyX device (EndoGastric Solutions, Inc., Redmond WA, USA) in patients with LPR. The study design would include up to 25 patients to receive the TIF procedure and will take 12 months to complete it. The investigators will compare objective and subjective outcomes at baseline and 3 months post TIF procedure to assess its efficacy against LPR. The investigators will submit the proposal to EndoGastric solutions, anticipating that they will cover part of the funding required to conduct our Pilot Study.
In conclusion, LPR lacks an effective therapy despite posing a significant healthcare burden. Medical therapy with PPI has a variable response, and more invasive Laparoscopic fundoplication is associated with a high risk of unwanted long-term side effects. TIF can potentially bridge this gap between medical and more invasive approaches for the patient population suffering from this condition. It has the potential to prove to be a less invasive and safe treatment indication for patients with chronic or refractory LPR who have either failed medical therapy or do not want to be on long-term medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPR Patients | Adults with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy undergoing endoscopic transoral incisionless fundoplication (TIF). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transoral Incisionless Fundoplication | Device | Transoral incisionless fundoplication (TIF) is a minimally invasive, endoscopic fundoplication technique. Transoral Incisionless Fundoplication (TIF) is an FDA approved endoluminal fundoplication technique which utilizes EsophyX device to restore the valve at the gastroesophageal junction. The EsophyX device (EndoGastric Solutions, Redmond, Wash, USA) is an FDA approved procedure for chronic of refractory GERD. |
| Measure | Description | Time Frame |
|---|---|---|
| LPR Symptoms | Number of participants reporting LPR symptom elimination or clinically significant improvement evaluated by RSI (Reflux Symptom Index) and GERD-HRQL Questionnaire. | Baseline and 3 months post-procedure |
| LPR Events | Number of participants with reduced LPR events as evaluated by HEMII-pH | Baseline and 3 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| GERD Symptoms | Elimination of Daily bothersome GERD symptoms evaluated by GERD-HRQL Questionnaire | Baseline and 3 months post-procedure |
| Patient Satisfaction | Patients Satisfaction evaluated by GERD-HRQL Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with diagnosed Laryngopharyngeal reflux (LPR) who are scheduled for endoscopic transoral incisionless fundoplication procedure (TIF).
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| Name | Affiliation | Role |
|---|---|---|
| Christopher C. Thompson, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23853213 | Background | El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13. | |
| 1895864 | Background | Koufman JA. The otolaryngologic manifestations of gastroesophageal reflux disease (GERD): a clinical investigation of 225 patients using ambulatory 24-hour pH monitoring and an experimental investigation of the role of acid and pepsin in the development of laryngeal injury. Laryngoscope. 1991 Apr;101(4 Pt 2 Suppl 53):1-78. doi: 10.1002/lary.1991.101.s53.1. |
| Label | URL |
|---|---|
| Safety information for the TIF procedure | View source |
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The plan to share data will be on a case by case basis. The other researchers may contact the PI and discuss study plans. An agreement through Mass General Brigham will need to be executed prior to sharing the de-identified data.
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|
| Baseline and 3 months post-procedure |
| Lower Esophageal Sphincter Tone | Change in Lower esophageal sphincter tone evaluated by Esophageal manometry | Baseline and 3 months post-procedure |
| Laryngopharyngeal anatomy | Change in Laryngopharyngeal anatomy evaluated by Laryngoscopy | Baseline and 3 months post-procedure |
| PPI Discontinuation | Discontinuation of PPI's | Baseline and 3 months post-procedure |
| 23545710 | Background | Francis DO, Rymer JA, Slaughter JC, Choksi Y, Jiramongkolchai P, Ogbeide E, Tran C, Goutte M, Garrett CG, Hagaman D, Vaezi MF. High economic burden of caring for patients with suspected extraesophageal reflux. Am J Gastroenterol. 2013 Jun;108(6):905-11. doi: 10.1038/ajg.2013.69. Epub 2013 Apr 2. |
| 31160182 | Background | Spantideas N, Drosou E, Bougea A, AlAbdulwahed R. Proton Pump Inhibitors for the Treatment of Laryngopharyngeal Reflux. A Systematic Review. J Voice. 2020 Nov;34(6):918-929. doi: 10.1016/j.jvoice.2019.05.005. Epub 2019 May 31. |
| 22890365 | Background | Fraser LA, Leslie WD, Targownik LE, Papaioannou A, Adachi JD; CaMos Research Group. The effect of proton pump inhibitors on fracture risk: report from the Canadian Multicenter Osteoporosis Study. Osteoporos Int. 2013 Apr;24(4):1161-8. doi: 10.1007/s00198-012-2112-9. Epub 2012 Aug 14. |
| 26752337 | Background | Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193. |
| 16843863 | Background | Ciovica R, Gadenstatter M, Klingler A, Lechner W, Riedl O, Schwab GP. Quality of life in GERD patients: medical treatment versus antireflux surgery. J Gastrointest Surg. 2006 Jul-Aug;10(7):934-9. doi: 10.1016/j.gassur.2006.04.001. |
| 21586712 | Background | Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626. |
| 29625507 | Background | McCarty TR, Itidiare M, Njei B, Rustagi T. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy. 2018 Jul;50(7):708-725. doi: 10.1055/a-0576-6589. Epub 2018 Apr 6. |
| 33553587 | Background | Testoni S, Hassan C, Mazzoleni G, Antonelli G, Fanti L, Passaretti S, Correale L, Cavestro GM, Testoni PA. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. 2021 Feb;9(2):E239-E246. doi: 10.1055/a-1322-2209. Epub 2021 Feb 3. |
| 21307014 | Background | Barnes WE, Hoddinott KM, Mundy S, Williams M. Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice. Surg Innov. 2011 Jun;18(2):119-29. doi: 10.1177/1553350610392067. Epub 2011 Feb 8. |
| 24487156 | Background | Wilson EB, Barnes WE, Mavrelis PG, Carter BJ, Bell RC, Sewell RW, Ihde GM, Dargis D, Hoddinott KM, Shughoury AB, Gill BD, Fox MA, Turgeon DG, Freeman KD, Gunsberger T, Hausmann MG, Leblanc KA, Deljkich E, Trad KS. The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience. Surg Laparosc Endosc Percutan Tech. 2014 Feb;24(1):36-46. doi: 10.1097/SLE.0b013e3182a2b05c. |
| 29405886 | Background | Trad KS, Barnes WE, Prevou ER, Simoni G, Steffen JA, Shughoury AB, Raza M, Heise JA, Fox MA, Mavrelis PG. The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective. Surg Innov. 2018 Apr;25(2):149-157. doi: 10.1177/1553350618755214. Epub 2018 Feb 6. |
| 30082108 | Background | Borges LF, Chan WW, Carroll TL. Dual pH Probes Without Proximal Esophageal and Pharyngeal Impedance May Be Deficient in Diagnosing LPR. J Voice. 2019 Sep;33(5):697-703. doi: 10.1016/j.jvoice.2018.03.008. Epub 2018 Aug 3. |
| 27217426 | Background | Carroll TL, Nahikian K, Asban A, Wiener D. Nissen Fundoplication for Laryngopharyngeal Reflux After Patient Selection Using Dual pH, Full Column Impedance Testing: A Pilot Study. Ann Otol Rhinol Laryngol. 2016 Sep;125(9):722-8. doi: 10.1177/0003489416649974. Epub 2016 May 23. |
| 23700139 | Background | Hoppo T, Komatsu Y, Jobe BA. Antireflux surgery in patients with chronic cough and abnormal proximal exposure as measured by hypopharyngeal multichannel intraluminal impedance. JAMA Surg. 2013 Jul;148(7):608-15. doi: 10.1001/jamasurg.2013.1376. |
| 23142603 | Background | Zerbib F, Roman S, Bruley Des Varannes S, Gourcerol G, Coffin B, Ropert A, Lepicard P, Mion F; Groupe Francais De Neuro-Gastroenterologie. Normal values of pharyngeal and esophageal 24-hour pH impedance in individuals on and off therapy and interobserver reproducibility. Clin Gastroenterol Hepatol. 2013 Apr;11(4):366-72. doi: 10.1016/j.cgh.2012.10.041. Epub 2012 Nov 8. |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
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