Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients

NCT05579587 | Withdrawn FDA Device

• 1 other identifier: 2022P000144
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Laryngopharyngeal Reflux (LPR); Reflux Disease, Gastro-Esophageal; Motility Disorder

Keywords

Transoral Incisionless Fundoplication (TIF); Fundoplication; Nissen Fundoplication; Proton Pump Inhibitor; Esophageal Manometry; Laryngoscopy; HEMII-pH; Reflux Symptom Index (RSI); GERD-HRQL

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• GERD Symptoms

  Baseline and 3 months post-procedure

• Patient Satisfaction

  Baseline and 3 months post-procedure

• Lower Esophageal Sphincter Tone

  Baseline and 3 months post-procedure

• Laryngopharyngeal anatomy

  Baseline and 3 months post-procedure

• PPI Discontinuation

  Baseline and 3 months post-procedure

Study Arms (1)

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).

Device: Transoral Incisionless Fundoplication

Interventions

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.

Also known as: TIF

LPR Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with diagnosed Laryngopharyngeal reflux (LPR) who are scheduled for endoscopic transoral incisionless fundoplication procedure (TIF).

You may qualify if:

• Any adult with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy.
• Having daily bothersome symptoms of LPR.
• Willing and able to cognitively sign a consent form for Surgical treatment of LPR with the TIF.
• Willing and available for follow up visit and repeat testing (HEMII-pH, Esophageal manometry and laryngoscopy) at 3 months post procedure.

You may not qualify if:

• Unable or unwilling to provide informed consent
• Unable or unwilling to comply with study procedures
• Body Mass Index \>35.
• Hiatal hernia\>2cm in axial height and \>2cm in greatest transverse dimension.
• Esophagitis grade C and D
• Barrett's esophagus\>2cm
• Esophageal ulcer
• Fixed esophageal stricture or narrowing
• Portal hypertension and/or varices
• Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis
• Gastroparesis
• Coagulation disorders
• History of any of the following: resective gastric or esophageal surgery, anti-reflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
• Pregnancy or plans of pregnancy in the next 12 months
• Enrollment in another device or drug study that may confound the results.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• EndoGastric Solutions: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (17)

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  PMID: 23853213 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.

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  PMID: 23545710 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.

  PMID: 31160182 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.

  PMID: 22890365 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.

  PMID: 26752337 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.

  PMID: 16843863 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.

  PMID: 21586712 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.

  PMID: 29625507 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.

  PMID: 33553587 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.

  PMID: 21307014 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.

  PMID: 24487156 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.

  PMID: 29405886 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.

  PMID: 30082108 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.

  PMID: 27217426 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.

  PMID: 23700139 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.

  PMID: 23142603 BACKGROUND

Related Links

• Safety information for the TIF procedure

MeSH Terms

Conditions

Gastroesophageal Reflux; Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Christopher C. Thompson, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: March 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: February 28, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

US (1)