CTIF vs LNF for Acid Reflux

(CTIF Trial)

Recruiting at 7 trial locations

Overseen By John Lipham, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hiatal hernia > 5 cm, Pregnancy, Previous anti-reflux procedure, BMI > 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, TIF and LNF, for patients with acid reflux and a hiatal hernia who are having hernia repair surgery. TIF is a non-surgical procedure done through the mouth, while LNF is a minimally invasive surgery. Both aim to stop acid reflux by improving the valve between the stomach and esophagus.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have pathologic reflux while off PPI (a type of medication for acid reflux), which suggests you may need to stop taking PPIs before the trial.

How does the treatment Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF) differ from other treatments for acid reflux?

This treatment is unique because it combines a laparoscopic repair of the hiatal hernia (a condition where part of the stomach pushes up through the diaphragm) with transoral incisionless fundoplication (TIF), an endoscopic procedure that doesn't require incisions. This approach is associated with fewer early and serious adverse events compared to the traditional laparoscopic Nissen fundoplication (LNF), and it may result in a shorter hospital stay and less bloating. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF) for acid reflux?

Research shows that combining hiatal hernia repair with TIF significantly improves symptoms of acid reflux, such as heartburn and regurgitation, with most patients experiencing effective symptom control and reduced medication use at 12 months. This approach also has fewer early and serious adverse events compared to traditional methods. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 22-80 with GERD and a hiatal hernia smaller than 5 cm, who have not had previous anti-reflux surgery. Participants must show signs of acid reflux, be able to consent, and commit to the study long-term. Those with severe gastroparesis, large hernias over 5 cm, significant esophageal disorders, or women who are pregnant cannot join.

Inclusion Criteria

You are willing to participate in the study for a long period of time.

I have severe GERD and a small hiatal hernia.

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

Exclusion Criteria

I have had surgery to prevent acid reflux.

You need to have a surgery that involves using a mesh implant at the same time as the study.

At the discretion of the site PI for subject safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Combo Transoral Incisionless Fundoplication (CTIF) or Laparoscopic Nissen Fundoplication (LNF) for treatment of GERD with hiatal hernia repair

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of esophagitis healing, PPI use cessation, and recurrence of hiatal hernia

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF)

Trial Overview The study compares two treatments for GERD in patients needing hiatal hernia repair: Laparoscopic Hiatal Hernia Repair combined with Transoral Incisionless Fundoplication (TIF) versus standard Laparoscopic Nissen Fundoplication (LNF). Patients will be randomly assigned to either treatment at multiple centers.

How Is the Trial Designed?

Group I: Combo Transoral Incisionless Fundoplication (CTIF) Active Control 1 Intervention

Treatment

Group II: Laparoscopic Nissen Fundoplication (LNF) Active Control 1 Intervention

Control

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

EndoGastric Solutions

Industry Sponsor

Trials

12

Recruited

3,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Fox Valley Surgical Associates

Collaborator

Trials

1

Recruited

140+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Institute of Esophageal and Reflux Surgery

Collaborator

Trials

1

Recruited

140+

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: A retrospective study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Novel Interdisciplinary Approach to GERD: Concomitant Laparoscopic Hiatal Hernia Repair with Transoral Incisionless Fundoplication. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Transoral Incisionless Fundoplication in a High-Risk Pediatric Population. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Endoscopic fundoplication for the treatment of gastroesophageal reflux disease: initial experience. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Revision of failed transoral incisionless fundoplication by subsequent laparoscopic Nissen fundoplication. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication. [2023]