Clinical trial · Interventional
Submental Flap for the Reconstruction of Hypopharyngectomy
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to assess the safety and efficacy of submental artery island flap (SMAIF) in the reconstruction of laryngeal and hypopharyngal defects after the surgical resection of hypopharyngeal cancer. The main questions it aims to answer are: * The survival of SMAIF and the recovery of laryngeal function. * The oncologic outcomes of SMAIF comparing with other reconstructions or radiotherapy. Participants will underwent partial laryngectomy and hypopharyngectomy and reconstruction of SMAIF. Postoperative adjuvant radiotherapy will be recommented when adverse pathologic features were noted.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers - Hypopharyngeal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical reconstruction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Submental artery flap reconstruction group
- interventionNames
- Other: Surgical reconstruction
Primary outcomes (2)
- measure
- The survival of submental artery island flap
- timeFrame
- one month after the end of the treatment
- description
- The survival rate of submental artery island flap (SMAIF)
- measure
- The recovery of laryngeal function
- timeFrame
- one month after the end of the treatment
- description
- the removal of nasogastric tube and tracheal tube
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * T2-T3 hypopharyngeal squamous cell carcinoma located in the piriform sinus or posterior hypopharyngeal wall cancer; * The contralateral hemilarynx is mobile; * the Eastern Cooperative Oncology Group (ECOG) performance status (PS) score was 0 or 1; * Without a history of radiotherapy. Exclusion Criteria: * Invasion into the cricoid cartilage and unable to reserve the larynx； * Pulmonary insufficiency, FEV1/FVC\<50%; * Unresctable neck diseases including carotid artery envoloped or tumor penetration to the prevertebral fascia or mediastinum; * Heart insufficincy whice intolerate to general anesthesia; * With distant metastasis.
References
Publications (10)
- BACKGROUNDJang JY, Kim EH, Cho J, Jung JH, Oh D, Ahn YC, Son YI, Jeong HS. Comparison of Oncological and Functional Outcomes between Initial Surgical versus Non-Surgical Treatments for Hypopharyngeal Cancer. Ann Surg Oncol. 2016 Jun;23(6):2054-61. doi: 10.1245/s10434-016-5088-4. Epub 2016 Jan 19. PMID 26786092
- BACKGROUNDMartin D, Pascal JF, Baudet J, Mondie JM, Farhat JB, Athoum A, Le Gaillard P, Peri G. The submental island flap: a new donor site. Anatomy and clinical applications as a free or pedicled flap. Plast Reconstr Surg. 1993 Oct;92(5):867-73. PMID 8415968
- BACKGROUNDChen R, Cai Q, Lin P, Liang F, Han P, Zhang L, Song P, Zhang T, Huang X. Role of immune-inflamed phenotype in the prognosis of hypopharyngeal carcinoma following primary surgery. Head Neck. 2023 Jan;45(1):126-134. doi: 10.1002/hed.27218. Epub 2022 Oct 12. PMID 36222335
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTGarneau JC, Bakst RL, Miles BA. Hypopharyngeal cancer: A state of the art review. Oral Oncol. 2018 Nov;86:244-250. doi: 10.1016/j.oraloncology.2018.09.025. Epub 2018 Oct 4. PMID 30409307
- RESULTHabib A. Management of advanced hypopharyngeal carcinoma: systematic review of survival following surgical and non-surgical treatments. J Laryngol Otol. 2018 May;132(5):385-400. doi: 10.1017/S0022215118000555. PMID 29891019
- RESULTEckel HE, Bradley PJ. Treatment Options for Hypopharyngeal Cancer. Adv Otorhinolaryngol. 2019;83:47-53. doi: 10.1159/000492308. Epub 2019 Feb 12. PMID 30943512