CTIF vs LNF for Acid Reflux

(CTIF Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods, TIF (Transoral Incisionless Fundoplication) and LNF (Laparoscopic Nissen Fundoplication), for treating GERD (acid reflux) in patients undergoing hernia repair. The goal is to determine which method is more effective and safer for those with frequent acid reflux. Participants should have GERD with a hiatal hernia less than 5 cm and experience acid reflux issues when not taking medications like PPIs. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective surgical options for GERD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Transoral Incisionless Fundoplication (TIF) is safe for patients with gastroesophageal reflux disease (GERD). One study found that TIF provided long-lasting relief from GERD symptoms, with 69-80% of patients experiencing successful outcomes. Other research indicates that TIF significantly improved GERD symptoms and maintained a good safety record.

Conversely, Laparoscopic Nissen Fundoplication (LNF) is a well-known procedure for treating GERD. It is generally well-tolerated and has demonstrated good safety and effectiveness over many years.

Both treatments have shown safety in previous studies, indicating they are well-tolerated options for patients with GERD undergoing hernia repair. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Combo Transoral Incisionless Fundoplication (CTIF) for acid reflux because it offers a less invasive approach compared to traditional surgeries like the Laparoscopic Nissen Fundoplication (LNF). Unlike LNF, which involves incisions and significant recovery time, CTIF is transoral, meaning it's done through the mouth without external cuts. This method potentially reduces recovery time and minimizes postoperative discomfort, making it an attractive option for patients. Additionally, by combining it with hiatal hernia repair, CTIF could provide a comprehensive solution for those dealing with both acid reflux and hernias.

What evidence suggests that this trial's treatments could be effective for GERD?

This trial will compare Combo Transoral Incisionless Fundoplication (CTIF) with Laparoscopic Nissen Fundoplication (LNF) for treating GERD. Research has shown that CTIF is effective, particularly for patients with hiatal hernias. Studies have found that it can normalize acid levels and reduce reflux episodes in up to 89% of patients. Additionally, 90% of patients experienced complete healing or reduced reflux esophagitis without medication after six months. For LNF, about 90% of patients showed increased pressure in the lower esophagus, effectively stopping acid reflux. Both treatments have demonstrated strong results in reducing GERD symptoms. ^{1 3 4 5 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3271216/

Long-term outcomes after transoral incisionless ... Reports suggest that the normalization of esophageal acid exposure and a number of reflux episodes after TIF could be achieved in up to 61 and 89% of patients, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4361451/

Transoral Incisionless Fundoplication Effective in ... Complete healing or reduction in reflux esophagitis at 6 months was achieved in 90% (18/20) of patients in the TIF group (off PPIs) compared with 38% (5/13) in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522311010932

Endoscopic fundoplication for the treatment of ... TIF is effective at short-term follow-up and safe for patients with GERD. However, long-term follow-up and randomized trials are required to assess the efficacy ...

4. gastrojournal.org gastrojournal.org/article/S0016-5085(18)30001-5/fulltext

Efficacy of Laparoscopic Nissen Fundoplication vs ... The Nissen or Toupet fundoplication is a true antireflux operation, increasing LES pressure and eliminating acid reflux in 90% of patients. Postoperative 30-day ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/17562848211004827

Transoral incisionless fundoplication demonstrates ... TIF 2 provides durable relief of GERD symptoms at up to 9 years with 69–80% of patients having a successful outcome by symptom response and PPI use.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01110811

Transoral Incisionless Fundoplication (TIF) Versus Sham ... The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) ...