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

• ClinicalTrials.gov Identifier: NCT04795934
• Recruitment Status: Recruiting
• First Posted: March 12, 2021
• Last Update Posted: November 13, 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
• Information provided by (Responsible Party): Barham K. Abu Dayyeh, M.D., Mayo Clinic

Tracking Information

• First Submitted Date: February 10, 2021
• First Posted Date: March 12, 2021
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: January 26, 2021
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 9, 2021)

• Change in AET [ Time Frame: [Time Frame: 6 months] ]
  Upper Endoscopy with 72 Hrs BravoPH Case Report Form
• Incidence of bloating [ Time Frame: [Time Frame: 6 months] ]
  Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
• Incidence of dysphagia [ Time Frame: [Time Frame: 6 months] ]
  Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form
• Change in distensibility index of GE junction [ Time Frame: [Time Frame: 6 months] ]
  Endoflip (optional) Case Report Form
• Cessation of Proton Pump Inhibitor (PPI) use [ Time Frame: [Time Frame: 6 months] ]
  PPI Use Questionnaire Case Report Form
• 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
• Recurrence of hiatal hernia [ Time Frame: [Time Frame: 6 months] ]
  Upper Endoscopy with 72 Hrs BravoPH Case Report Form
• Hill grade of GE junction [ Time Frame: [Time Frame: 6 months] ]
  Upper Endoscopy with 72 Hrs BravoPH Case Report Form
• Adverse events rate [ Time Frame: [Time Frame: 6 months] ]
  Adverse Event Case Report Form

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• GERD
• Hiatal Hernia

Intervention

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

Study Arms

• Active Comparator: Laparoscopic Nissen Fundoplication (LNF)
  Control
  Intervention: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
• Active Comparator: Combo Transoral Incisionless Fundoplication (CTIF)
  Treatment
  Intervention: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 9, 2021): 142
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04795934
• Other Study ID Numbers: 19-005226
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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.

• Current Responsible Party: Barham K. Abu Dayyeh, M.D., Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current

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

• Investigators: Not Provided
• PRS Account: Mayo Clinic
• Verification Date: November 2023