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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795934
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : February 2, 2023
Sponsor:
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
Information provided by (Responsible Party):
Barham K. Abu Dayyeh, M.D., Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
GERD Hiatal Hernia Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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.
Primary Purpose: Other
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
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Laparoscopic Nissen Fundoplication (LNF)
Control
 Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Other Name: LAPAROSCOPIC NISSEN FUNDOPLICATION
Active Comparator: Combo Transoral Incisionless Fundoplication (CTIF)
Treatment
 Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Other Name: LAPAROSCOPIC NISSEN FUNDOPLICATION


Outcome Measures
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Primary Outcome Measures :
  1. Mean difference in HRQL score ≤ 15% [ Time Frame: 6 months ]

    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 :
  1. Change in AET [ Time Frame: [Time Frame: 6 months] ]
    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  2. Incidence of bloating [ Time Frame: [Time Frame: 6 months] ]
    Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form

  3. Incidence of dysphagia [ Time Frame: [Time Frame: 6 months] ]
    Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form

  4. Change in distensibility index of GE junction [ Time Frame: [Time Frame: 6 months] ]
    Endoflip (optional) Case Report Form

  5. Cessation of Proton Pump Inhibitor (PPI) use [ Time Frame: [Time Frame: 6 months] ]
    PPI Use Questionnaire Case Report Form

  6. Healing of esophagitis [ Time Frame: [Time Frame: 6 months] ]

    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


  7. Recurrence of hiatal hernia [ Time Frame: [Time Frame: 6 months] ]
    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  8. Hill grade of GE junction [ Time Frame: [Time Frame: 6 months] ]
    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  9. Adverse events rate [ Time Frame: [Time Frame: 6 months] ]
    Adverse Event Case Report Form


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795934


Locations
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United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92697
Contact: Kenneth J Chang, MD    714-456-6187    kchang@hs.uci.edu   
Contact: Figueroa Cesar    714-456-7539    figuerc1@hs.uci.edu   
Sub-Investigator: Ninh T Nguyen, MD         
Principal Investigator: Kenneth J Chang, MD         
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: John C Lipham, MD    323-442-9067    John.Lipham@med.usc.edu   
Contact: Stephanie Varela    213-220-5885    stephanie.varela@med.usc.edu   
Principal Investigator: John C Lipham, MD         
United States, Colorado
Institute of Esophageal and Reflux Surgery Recruiting
Englewood, Colorado, United States, 880113
Contact: Reginald Bell, M.D.    303-788-7700    reg@iersurgery.com   
Contact: Rachel Heidrick    303-788-1636    rachel@iersurgery.com   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Elizabeth A Lemke, MPH    507-266-3317    Lemke.Elizabeth@mayo.edu   
Contact: Samantha Thorson    507-255-4803    Thorson.Samantha@Mayo.edu   
Principal Investigator: Barham K Abu Dayyeh, MD         
Sub-Investigator: Reisenauer S Janani, MD         
United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Rose "RJ" Goodrich    512-495-2112    rose.jonesgoodrich@austin.utexas.edu   
Principal Investigator: F. P. "Tripp" Buckley III, MD, FACS         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Erik B Wilson, MD    713-486-1338    Erik.B.Wilson@uth.tmc.edu   
Contact: Connie Pollard       Connie.Pollard@uth.tmc.edu   
Principal Investigator: Erik B Wilson, MD         
United States, Wisconsin
Fox Valley Surgical Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Peter G Janu    920-277-3015    Peter.Janu@fvsawi.com   
Contact: Wendy       pjanu@new.rr.com   
Principal Investigator: Peter G Janu, MD         
Sponsors and Collaborators
Mayo Clinic
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
More Information
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Additional Information:

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Responsible Party: Barham K. Abu Dayyeh, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04795934    
Other Study ID Numbers: 19-005226
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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
Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic
Internal Hernia