Injection vs Suture Repair for Laryngeal Cleft

Enrolling by invitation at 1 trial location

Overseen By Derek Lam, MD MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Cerebral palsy, Down syndrome, Prematurity, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two procedures to help children with swallowing problems caused by a laryngeal cleft, a gap in the airway. Injection laryngoplasty involves injecting a gel to prevent food and liquid from entering the airway, while endoscopic suture repair uses stitches to close the gap. The trial aims to determine which method better improves swallowing issues. Children who struggle to swallow liquids despite thickening them for two months may be suitable candidates for this trial. Participants will undergo tests and complete questionnaires to monitor changes in their swallowing. As an unphased trial, this study provides a unique opportunity for children to access potentially beneficial treatments and contribute to important medical research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these procedures are safe for treating swallowing issues?

Research has shown that both endoscopic suture repair and injection laryngoplasty are generally safe for treating laryngeal clefts. Studies have found that endoscopic suture repair has a high success rate of 90% to 100% in patients who underwent the procedure, indicating it often works well and is usually easy for patients to handle. However, there is a small risk of complications, such as tissue separation after surgery.

For injection laryngoplasty, research indicates it is safe and effective, even for very young children. Studies have shown no major safety differences between age groups, suggesting it is generally well-tolerated.

Both procedures aim to help with swallowing problems by preventing food and liquid from entering the airway. While both have good safety records, potential participants should discuss any specific concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for laryngeal cleft because they offer less invasive alternatives to traditional open surgical repair. Endoscopic suture repair involves using a scope to stitch the cleft from within the throat, potentially reducing recovery time and surgical risk. Injection laryngoplasty, on the other hand, involves injecting material into the interarytenoid space to close the cleft, providing a non-surgical option that can be done quickly and may be suitable for less severe cases. Both methods aim to improve outcomes with fewer complications and quicker recovery times compared to conventional open surgery.

What evidence suggests that this trial's procedures could be effective for swallowing issues?

This trial will compare two treatments for laryngeal clefts: endoscopic suture repair and injection laryngoplasty. Research has shown that endoscopic suture repair, one of the treatments in this trial, effectively fixes laryngeal clefts, with success rates between 90% and 100%. This procedure uses stitches to strengthen the airway wall, reducing the chance of food and liquid entering the airway. Studies also indicate that this method is long-lasting and requires less time in surgery. Meanwhile, injection laryngoplasty, the other treatment option in this trial, involves injecting a gel to prevent food and liquid from entering the airway. Parents and caregivers have reported a significant improvement in swallowing symptoms with this method. Both treatments effectively improve swallowing issues related to laryngeal clefts. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with laryngeal cleft or post-extubation dysphagia, which are conditions that cause difficulty swallowing. Participants will undergo tests and procedures to assess their swallowing before and after treatment.

Inclusion Criteria

My child has swallowing issues, needs thickened liquids, and hasn't improved after 2 months.

Exclusion Criteria

Cerebral palsy

Down syndrome

Any syndrome with significant hypotonia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either injection laryngoplasty or endoscopic suture repair

1 week

1 visit (in-person)

Post-operative Monitoring

Participants are monitored overnight in the hospital after the procedure

1 night

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including VFSS and questionnaires

3 months

2 visits (in-person)

Long-term Follow-up

Participants have follow-up in clinic for up to 2 years after the procedure

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic suture repair
• Injection laryngoplasty

Trial Overview

The study compares two procedures aimed at improving swallowing issues: injection laryngoplasty (IL), where a gel is injected into the airway, and endoscopic suture repair (ER), where sutures build up the airway wall.

How Is the Trial Designed?

Group I: Endoscopic suture repair Experimental Treatment 1 Intervention

Children receiving endoscopic suture repair of laryngeal cleft

Group II: Injection laryngoplasty Active Control 1 Intervention

Children receiving injection of the interarytenoid space of laryngeal cleft

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9535053/

Endoscopic Repair of Laryngeal Clefts: 8 Years' Experience

Chiang et al. found good results using P2 needles for the surgical management of type 1 and 2 clefts. The upper limit of cleft repair was just below the ...

2.

aao-hnsfjournals.onlinelibrary.wiley.com

aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815576718

Outcomes and Resource Utilization of Endoscopic Mass ...

Endoscopic laryngeal cleft repair using a mass-closure technique provides a durable result while requiring significantly shorter operative times ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587619304847

Long-term swallowing outcomes following type 1 laryngeal ...

Improvement was noted in 12 (50%) patients within 30 days of IIA, with 11 of 12 demonstrating sustained improvement at long-term follow up (10.3 [9.3–14.0] ...

4.

theajo.com

theajo.com/article/view/4151/html

Diagnosis and management of type 1 laryngeal cleft

A high success rate of 90% to 100% in patients who subsequently underwent surgical repair was reported (20,44). This may possibly reflect the ...

5.

frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1113894/full

Endoscopic percutaneous repair of laryngeal cleft

In conclusion, endoscopic percutaneous repair with the open transcervical approach significantly reduces perioperative and postoperative morbidity. Endoscopic ...

6.

aao-hnsfjournals.onlinelibrary.wiley.com

aao-hnsfjournals.onlinelibrary.wiley.com/doi/abs/10.1177/0194599814541627a145

Outcomes and Resource Utilization of Endoscopic Mass ...

Conclusions: The endoscopic mass-closure technique is safe, fast, technically straightforward, and produces swallowing outcomes similar to ...