Registry to Compare Two Surgical Treatments for GERD

GastroEsophageal Reflux Disease Clinical Trial

— STAR Registry  

Official title:

Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti- Reflux Treatment Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02211105
• Other study ID #: AGA STAR Registry
• Status: Terminated
• Phase: N/A
• First received: August 5, 2014
• Last updated: January 8, 2018
• Start date: July 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: American Gastroenterological Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.

Description:

This registry will prospectively enroll 500 patients undergoing TIF and LNF from approximately 20 United States centers proficient in these procedures that have provided informed consent for the above mentioned data collection (symptom questionnaires, medical treatments, complications, side-effects and costs). The observational registry will obtain the patients clinical data related to gastrointestinal symptoms for three years post-consent.

At baseline and for a three-year period following a clinically indicated TIF or LNF procedure, data will be obtained from phone calls and/or during office-visits made at specified intervals. During these data collection periods, patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the upper abdomen into the chest, and or regurgitation, defined as the effortless arising of liquid material into the chest or mouth) two or more times a week (when not on anti-secretory medication) that adversely affects the patient's quality of life. Additionally, patients will have to have responded to medical therapy (adequate relief of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In this context, scores = 2 on each GERD-HRQL and regurgitation question (while on medication) indicate absence of daily bothersome symptoms and therefore these patients are considered responsive to medical therapy. Furthermore, patients will have to have objective evidence of GERD documented (esophagitis on endoscopy or pathological intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).

• Age 18-80 years

• Ability to give informed consent

• Regular access to a telephone

• Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or LNF within 90 days of providing consent.

• Dependent upon PPIs for control of heartburn for > six months or patient determined to have an inadequate response of regurgitation symptoms despite heartburn control with PPIs

• Hiatal hernia axial length is no larger than 2 cm and the transverse dimension should not exceed 2.0 cm

• Gastroesophageal junction with a Hill Grade I-II

--- Patient willing to provide informed consent, cooperate with post-operative dietary recommendations and follow-up assessment tests

• Objective documentation of pathological acid-reflux by either a) increased intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring (pH<4 for 4.5% or greater of the time) with or without impedance b) or the presence of erosive esophagitis (LA Grade A or B) on endoscopy

• Absence of a severe esophageal motility disorder (note: mild abnormalities in esophageal motility are common in GERD such as small breaks, etc.) including achalasia, esophagogastric junction outflow obstruction, frequent failed peristalsis, diffuse esophageal spasm, nutcracker or jackhammer esophagus etc. on high-resolution esophageal manometry using the Chicago classification system or evidence of incomplete bolus clearance on 30% or more of swallows by impedance testing.

Exclusion Criteria:

• Hiatal hernia > 2 cm (defined as longitudinal length measured endoscopically between the proximal margin of the gastric folds and the diaphragmatic pinch)

• Esophagitis LA Grade C or D

• Presence of troublesome atypical symptoms

• Barrett's esophagus greater than 2 cm in length or with any dysplasia

• Esophageal stricture or severe esophageal motility disorder

• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, cirrhosis or any other uncontrolled systemic disease

--. Active gastro-duodenal ulcer disease

• Gastric outlet obstruction or stenosis

• Gastroparesis or delayed gastric emptying confirmed by a four hour solid-phase gastric emptying study

• Body Mass Index (BMI) > 35

• Pregnancy or plans for pregnancy within 12 months of the procedure

• Portal hypertension and/or varices

• New York Heart Association classification of III or IV.

• Coagulation disorders

• Intraprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe performance of the procedure

• Enrollment in another device or drug study that may confound result

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GastroEsophageal Reflux Disease

Locations

Country	Name	City	State
United States	University of Texas at Houston	Bellaire	Texas
United States	GI Solutions Inc	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	SurgOne Foregut Institute	Englewood	Colorado
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	OC Reflux	Huntington Beach	California
United States	Lenox Hill Hospital	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Reston Hospital Center/ GW University	Reston	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
American Gastroenterological Association	EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability of GERD surgeries	Compare the durability of TIF to LNF by determining the proportion of patients that achieve either a) >75% or b) >50% within the first year that maintain this effect at three years	1 year and 3 years
Other	Comparison of TIF to LNF for Patient reported symptoms	Compare TIF to LNF with respect to other reported GI symptoms, complications and side effects.	3 years
Other	Comparison of Post-Procedure cost	Estimate the post-procedure costs associated with episodes of care and any ensuing complications or side effects of TIF and LNF.	3 years
Primary	Effectiveness as measured by a 75% reduction in GERD HRQL)	To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.	3 years
Secondary	Effectiveness using a 50% reduction in GERD-HRQL	Compare effectiveness using a 50% reduction in GERD-HRQL as a threshold for effectiveness of TIF and LNF at the end of three years compared to baseline.	3 years