Skip to content

Efficacy Study of a Transnasal negative pressure therapy for Pharyngeal Fistula Patients: A Multicenter Randomized Controlled Clinical Trial

Efficacy Study of a Transnasal negative pressure therapy for Pharyngeal Fistula Patients: A Multicenter Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091407
Enrollment
Unknown
Registered
2024-10-28
Start date
2024-10-30
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced laryngeal or hypopharyngeal cancer

Interventions

Control Group:Localized pressure + drainage
intervention Group:TNPT+Localized pressure + drainage

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 years = age = 80 years; 2.Post total laryngeal surgery; 3.Pharyngeal fistula diagnosed by esophagography; 4.General condition, ability to tolerate general anesthesia as well as surgery, and physical condition = 2 on the Eastern Cooperative Oncology Group (ECOG) scale; 5.Willingness and ability to comply with study visits and treatment plans and other study procedures.

Exclusion criteria

Exclusion criteria: 1.Those who suffer from other serious diseases for control such as tuberculosis, leprosy, etc. at the same time; 2.Accompanied by serious abnormalities in the functioning of vital organs such as heart, brain and lungs; 3.Do not agree to sign the informed consent form;

Design outcomes

Primary

MeasureTime frame
Time to Pharyngeal Fistula Healing;

Secondary

MeasureTime frame
Recovery rate;Number of dressing changes required for pharyngeal fistula treatment;EORTC Quality of Life Questionnaire Head and Neck (H&N )-35;

Countries

China

Contacts

Public ContactChen lin

The First Affiliated Hospital,Sun Yat-sen University

chenlin66@mail.sysu.edu.cn+86 20 87338402

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026