search
Back to results

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair (CTIF)

Primary Purpose

GERD, Hiatal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for GERD

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 22-80 years of age
  2. Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV

  3. Pathologic reflux while off PPI based on Lyon criteria by either of the following:

    3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.

    3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.

  4. Commitment to long-term study
  5. Ability to give consent individually or by a legally authorized representative

Exclusion Criteria:

  1. Hiatal hernia > 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery)
  2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
  3. Pregnancy (in females) at time of procedure
  4. Previous anti-reflux procedure
  5. Subjects requiring mesh treatment at time of procedure
  6. At the discretion of the site PI for subject safety
  7. BMI > 35 at time of surgery.
  8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
  9. Severe gastroparesis

Sites / Locations

  • University of California IrvineRecruiting
  • University of Southern California
  • Institute of Esophageal and Reflux SurgeryRecruiting
  • Mayo Clinic in RochesterRecruiting
  • The University of Texas at AustinRecruiting
  • University of Texas Health Science Center at HoustonRecruiting
  • Fox Valley SurgicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic Nissen Fundoplication (LNF)

Combo Transoral Incisionless Fundoplication (CTIF)

Arm Description

Control

Treatment

Outcomes

Primary Outcome Measures

Mean difference in HRQL score ≤ 15%
Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score. GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

Secondary Outcome Measures

Change in AET
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Incidence of bloating
Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
Incidence of dysphagia
Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
Change in distensibility index of GE junction
Endoflip (optional) Case Report Form
Cessation of Proton Pump Inhibitor (PPI) use
PPI Use Questionnaire Case Report Form
Healing of esophagitis
Upper Endoscopy with 72 Hrs BravoPH Case Report Form assessing LA Grade system: A, B, C, or D (if present) Grade A One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal folds Grade B One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal folds Grade C One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which involve less than 75% of the circumference Grade D One (or more) mucosal break which involves at least 75% of the esophageal circumference
Recurrence of hiatal hernia
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Hill grade of GE junction
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Adverse events rate
Adverse Event Case Report Form

Full Information

First Posted
February 10, 2021
Last Updated
January 31, 2023
Sponsor
Mayo Clinic
Collaborators
EndoGastric Solutions, University of California, Irvine, Fox Valley Surgical Associates, University of Southern California, The University of Texas Health Science Center, Houston, University of Texas at Austin, Institute of Esophageal and Reflux Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT04795934
Brief Title
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
Acronym
CTIF
Official Title
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication for Treatment of Gastroesophageal Reflux Disease in Patients Requiring Hiatal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
EndoGastric Solutions, University of California, Irvine, Fox Valley Surgical Associates, University of Southern California, The University of Texas Health Science Center, Houston, University of Texas at Austin, Institute of Esophageal and Reflux Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Hiatal Hernia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
Measures will be taken to minimize or avoid bias in the study "masking/blinding procedures." Neither treatment groups will be advised as to which procedure (TIF or LNF) they will be receiving. Randomization assignment will be recorded in the EDC and subject tracking, but will not be recorded within the EMR to reduce clinical team exposure to their randomized status for follow-up care. Research teams will not be blinded to the randomization results.
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Nissen Fundoplication (LNF)
Arm Type
Active Comparator
Arm Description
Control
Arm Title
Combo Transoral Incisionless Fundoplication (CTIF)
Arm Type
Active Comparator
Arm Description
Treatment
Intervention Type
Procedure
Intervention Name(s)
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Other Intervention Name(s)
LAPAROSCOPIC NISSEN FUNDOPLICATION
Intervention Description
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Primary Outcome Measure Information:
Title
Mean difference in HRQL score ≤ 15%
Description
Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score. GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in AET
Description
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Incidence of bloating
Description
Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Incidence of dysphagia
Description
Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Change in distensibility index of GE junction
Description
Endoflip (optional) Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Cessation of Proton Pump Inhibitor (PPI) use
Description
PPI Use Questionnaire Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Healing of esophagitis
Description
Upper Endoscopy with 72 Hrs BravoPH Case Report Form assessing LA Grade system: A, B, C, or D (if present) Grade A One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal folds Grade B One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal folds Grade C One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which involve less than 75% of the circumference Grade D One (or more) mucosal break which involves at least 75% of the esophageal circumference
Time Frame
[Time Frame: 6 months]
Title
Recurrence of hiatal hernia
Description
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Hill grade of GE junction
Description
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time Frame
[Time Frame: 6 months]
Title
Adverse events rate
Description
Adverse Event Case Report Form
Time Frame
[Time Frame: 6 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 22-80 years of age Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV Pathologic reflux while off PPI based on Lyon criteria by either of the following: 3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis. 3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B. Commitment to long-term study Ability to give consent individually or by a legally authorized representative Exclusion Criteria: Hiatal hernia > 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator Pregnancy (in females) at time of procedure Previous anti-reflux procedure Subjects requiring mesh treatment at time of procedure At the discretion of the site PI for subject safety BMI > 35 at time of surgery. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty. Severe gastroparesis
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth J Chang, MD
Phone
714-456-6187
Email
kchang@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Figueroa Cesar
Phone
714-456-7539
Email
figuerc1@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Ninh T Nguyen, MD
First Name & Middle Initial & Last Name & Degree
Kenneth J Chang, MD
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John C Lipham, MD
Phone
323-442-9067
Email
John.Lipham@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Varela
Phone
213-220-5885
Email
stephanie.varela@med.usc.edu
First Name & Middle Initial & Last Name & Degree
John C Lipham, MD
Facility Name
Institute of Esophageal and Reflux Surgery
City
Englewood
State/Province
Colorado
ZIP/Postal Code
880113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reginald Bell, M.D.
Phone
303-788-7700
Email
reg@iersurgery.com
First Name & Middle Initial & Last Name & Degree
Rachel Heidrick
Phone
303-788-1636
Email
rachel@iersurgery.com
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Lemke, MPH
Phone
507-266-3317
Email
Lemke.Elizabeth@mayo.edu
First Name & Middle Initial & Last Name & Degree
Samantha Thorson
Phone
507-255-4803
Email
Thorson.Samantha@Mayo.edu
First Name & Middle Initial & Last Name & Degree
Barham K Abu Dayyeh, MD
First Name & Middle Initial & Last Name & Degree
Reisenauer S Janani, MD
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rose "RJ" Goodrich
Phone
512-495-2112
Email
rose.jonesgoodrich@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
F. P. "Tripp" Buckley III, MD, FACS
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik B Wilson, MD
Phone
713-486-1338
Email
Erik.B.Wilson@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Connie Pollard
Email
Connie.Pollard@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Erik B Wilson, MD
Facility Name
Fox Valley Surgical
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter G Janu
Phone
920-277-3015
Email
Peter.Janu@fvsawi.com
First Name & Middle Initial & Last Name & Degree
Wendy
Email
pjanu@new.rr.com
First Name & Middle Initial & Last Name & Degree
Peter G Janu, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Health information may be collected from: Past, present and future medical records. Research procedures, including research office visits, tests, interviews and questionnaires. Health information will be used and/or given to others to: Do the research. Report the results. See if the research was conducted following the approved study plan, and applicable rules and regulations. Health information may be used and shared with: Mayo Clinic research staff involved in this study or clinical care. Researchers involved in this study at other institutions. The sponsor of this study and the people or groups hired by the sponsor to help perform this research. The Mayo Clinic Institutional Review Board that oversees the research. Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

We'll reach out to this number within 24 hrs