Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

Gastroesophageal Reflux Disease (GERD) Clinical Trial

— TvP  

Official title:

A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00857597
• Other study ID #: D00668-01C
• Secondary ID: PRO08110069
• Status: Terminated
• Phase: Phase 3
• First received: March 4, 2009
• Last updated: March 28, 2018
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)

• On daily PPIs for > 1 year

• Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)

• Normal or hypotonic LES resting pressure (5-40 mmHg)

• Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol

• Signed informed consent

Exclusion Criteria:

• BMI > 35

• Hiatal hernia > 2 cm

• Esophagitis grade D

• Barrett's esophagus

• Esophageal stricture

• Esophageal ulcer

• Esophageal motility disorder

• Gastric motility disorder

• Prior splenectomy

• Gastric paralysis

• Pregnancy (in females)

• Immunosuppression

• ASA > 2

• Portal hypertension

• Coagulation disorders

• Previous antireflux procedure

• Any other health condition, which the investigator believes would prevent the patient from completing the study

• Lack of fluency in English

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Procedure:
• Transoral Incisionless Fundoplication
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.

Drug:
• Proton Pump Inhibitors; active control
Proton Pump Inhibitors; active control

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Crospon, EndoGastric Solutions, Sandhill Scientific

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD symptoms		Baseline
Primary	GERD symptoms		6 month follow-up
Primary	GERD symptoms		12 month follow-up
Secondary	PPI usage		at 0, 6 and 12 month follow- up
Secondary	Lower esophageal acid exposure		at 0, 6 and 12 month follow- up
Secondary	Esophagitis	Percentage of Participants with Esophagitis (Los Angeles classification scale)	at 0, 6 and 12 month follow- up
Secondary	Rate of adverse events		at 0, 6 and 12 month follow- up

External Links

•   Data reported in Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31.