What side effects are associated with this type of intervention?

Transoral Incisionless Fundoplication (TIF) and Laparoscopic Nissen Fundoplication (LNF) are common surgical treatments for acid reflux. TIF is generally safe but can lead to side effects such as temporary difficulty swallowing, bloating, and chest pain. LNF, while effective, has a broader range of potential complications including gas bloat syndrome, dysphagia (difficulty swallowing), small bowel obstruction, and the need for reoperation in some cases. Both procedures aim to reduce acid reflux but come with risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for acid reflux, including surgical procedures like Transoral Incisionless Fundoplication (TIF) and Laparoscopic Nissen Fundoplication (LNF). TIF reconstructs the valve between the esophagus and stomach to prevent acid reflux, while LNF involves wrapping the stomach around the esophagus to achieve the same goal. Additionally, proton pump inhibitors (PPIs) such as esomeprazole and lansoprazole have been approved for managing acid reflux symptoms. These treatments offer alternatives to patients who do not respond adequately to medication alone.

What other types of research exist?

Promising novel alternatives to TIF and LNF for acid reflux patients include: 1) Acupuncture, which has shown efficacy in clinical trials for refractory heartburn. 2) The use of antidepressants like venlafaxine and low-dose amitriptyline, which have been effective in treating functional chest pain and hypersensitive esophagus. 3) Addition of prokinetics to PPI therapy, which has been supported by meta-analysis for improving GERD symptoms. 4) IW-3718, a bile acid sequestrant, which has shown promise in reducing heartburn severity in refractory GERD patients.

← Back to Search

Procedure

CTIF vs LNF for Acid Reflux (CTIF Trial)

N/A

Waitlist Available

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

Previous anti-reflux procedure

BMI > 35 at time of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the procedure, digestive issues such as bloating or gas (known as 'gas bloat syndrome'), difficulty swallowing if too tight a wrap is made around the esophagus during LNF, and anesthesia-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe GERD and a small hiatal hernia.

Select...

My tests show severe acid reflux or serious damage to my esophagus.

Select...

I have severe GERD and a small hiatal hernia.

Select...

I am between 22 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery to prevent acid reflux.

Select...

My BMI was over 35 at the time of my surgery.

Select...

I have not had stomach surgery that affects its function or the ability to perform certain medical procedures.

Select...

I have severe stomach emptying issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean difference in HRQL score ≤ 15%

Secondary study objectives

Adverse events rate

Cessation of Proton Pump Inhibitor (PPI) use

Change in AET

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Combo Transoral Incisionless Fundoplication (CTIF)Active Control1 Intervention

Treatment

Group II: Laparoscopic Nissen Fundoplication (LNF)Active Control1 Intervention

Control

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transoral Incisionless Fundoplication (TIF) and Laparoscopic Nissen Fundoplication (LNF) are surgical treatments for acid reflux that enhance the function of the lower esophageal sphincter (LES). TIF reconstructs the valve between the esophagus and stomach using an endoscopic approach, preventing acid from flowing back into the esophagus. LNF involves wrapping the upper part of the stomach around the lower esophagus to strengthen the LES and prevent reflux. These procedures are important for patients as they offer long-term relief from GERD symptoms by addressing the root cause of acid reflux.