JRCT ID: jRCT1042250216
Registered date:25/03/2026
Randomized Controlled Trial of the Modified Killian Method
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Head and neck squamous cell carcinoma and esophageal squamous cell carcinoma (high-risk population) |
| Date of first enrollment | 25/03/2026 |
| Target sample size | 56 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Hypopharyngeal observation will be performed using an ultrathin endoscope. Participants will undergo both the conventional Valsalva method and the Modified Killian method in a randomized crossover design. The Modified Killian method uses neck flexion and head rotation to improve visualization. |
Outcome(s)
| Primary Outcome | Hypopharyngeal visibility score assessed using the Murono score |
|---|---|
| Secondary Outcome | 1. Visibility of the pyriform sinus 2. Lesion detection rate 3. Observation time 4. Adverse events 5. Patient discomfort |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Patients with a history of esophageal squamous cell carcinoma or head and neck squamous cell carcinoma 2. Age over 18 years 3. Written informed consent obtained |
| Exclude criteria | 1. Advanced cancer in the pharyngolaryngeal region 2. Inability to maintain a sitting position 3. Cervical spine disorders preventing neck movement 4. Pregnancy or suspected pregnancy 5. Patients judged inappropriate by investigators |
Related Information
| Primary Sponsor | Ikenoyama Yohei |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Aiji Hattori |
| Address | 2-174, Edobashi, Tsu, Mie Mie Japan 514-8507 |
| Telephone | +81-592321111 |
| aiji-h@med.mie-u.ac.jp | |
| Affiliation | Mie University Graduate School of Medicine |
| Scientific contact | |
| Name | Yohei Ikenoyama |
| Address | 2-174, Edobashi, Tsu, Mie Mie Japan 514-8507 |
| Telephone | +81-592321111 |
| 0801yohei@med.mie-u.ac.jp | |
| Affiliation | Mie University Graduate School of Medicine |