Registry to Compare Two Surgical Treatments for GERD (STAR Registry)

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

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.

Study Overview

• Status: Terminated
• Conditions: GastroEsophageal Reflux Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States
      • OC Reflux
  • Colorado
    • Englewood, Colorado, United States, 80110
      • SurgOne Foregut Institute
  • Illinois
    • Chicago, Illinois, United States
      • GI Solutions Inc
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem
  • New York
    • New York, New York, United States, 10011
      • Lenox Hill Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University
  • Texas
    • Bellaire, Texas, United States, 77401
      • University of Texas at Houston
    • El Paso, Texas, United States, 79912
      • Texas Tech University Health Sciences Center
  • Virginia
    • Reston, Virginia, United States, 20190
      • Reston Hospital Center/ GW University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who meet clinical criteria and have decided to treat their GERD through one of two surgical procedures, (LNF or TIF) and agree to have their standard GI medical data for 3 years.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Laparoscopic Nissen Fundoplication; Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication.
Transoral Incisionless Fundoplication; Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: American Gastroenterological Association
• Collaborators: EndoGastric Solutions
• Investigators: Principal Investigator: M. Brian Fennerty, M.D., Oregon Health and Science University; Principal Investigator: W. Scott Melvin, M.D., Montefiore Medical Center; Study Chair: Ashish Atreja, M.D., Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: GastroEsophageal Reflux Disease; Transoral Incisionless Fundoplication; Laparoscopic Nissen Fundoplication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: AGA STAR Registry