NCT06161779

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
46mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Feb 2023Feb 2030

Study Start

First participant enrolled

February 16, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2030

Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

5 years

First QC Date

September 4, 2023

Last Update Submit

December 7, 2023

Conditions

Head and Neck Cancers - Hypopharyngeal

Outcome Measures

Primary Outcomes (2)

  • The survival of submental artery island flap

    The survival rate of submental artery island flap (SMAIF)

    one month after the end of the treatment

  • The recovery of laryngeal function

    the removal of nasogastric tube and tracheal tube

    one month after the end of the treatment

Secondary Outcomes (3)

  • Overall survival of patients underwent the treatment with SMAIF reconstruction.

    2-year and 5-year after the initiation of treatment

  • Disease-free survival of patients underwent the treatment with SMAIF reconstruction.

    2-year and 5-year after the initiation of treatment

  • Local control rate of patients underwent the treatment with SMAIF reconstruction.

    2-year and 5-year after the initiation of treatment

Study Arms (1)

Submental artery flap reconstruction group

EXPERIMENTAL
Other: Surgical reconstruction

Interventions

Surgical reconstructionOTHER

submental artery island flap (SMAIF) for the reconstruction of laryngeal and hypopharyngal defects after the surgical resection of hypopharyngeal cancer

Submental artery flap reconstruction group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (10)

  • Jang 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: 26786092BACKGROUND

  • Martin 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: 8415968BACKGROUND

  • Chen 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: 36222335BACKGROUND

  • Sung 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: 33538338RESULT

  • Garneau 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: 30409307RESULT

  • Habib 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: 29891019RESULT

  • Eckel HE, Bradley PJ. Treatment Options for Hypopharyngeal Cancer. Adv Otorhinolaryngol. 2019;83:47-53. doi: 10.1159/000492308. Epub 2019 Feb 12.

    PMID: 30943512RESULT

  • Cai Q, Liang F, Huang X, Han P, Pan Y, Zheng Y. Hypopharynx and larynx defect repair after resection for pyriform fossa cancer with a platysma skin flap. Otolaryngol Head Neck Surg. 2015 Feb;152(2):374-6. doi: 10.1177/0194599814559508. Epub 2014 Nov 26.

    PMID: 25428776RESULT

  • Chen L, Si Y, Lin P, Guan Z, Zhu W, Liang H, Cai Q. Surgical treatment of T2-3 posterior hypopharyngeal carcinoma with preservation of laryngeal function. Acta Otolaryngol. 2021 Sep;141(9):851-856. doi: 10.1080/00016489.2021.1965211. Epub 2021 Aug 30.

    PMID: 34459710RESULT

  • Pang W, Zhang A, Lu C, Tian J, Li WX, Wang Z, Dong Y, Yuan S, Niu Z, Zhu Y, Quraishi MS, Liu L. Design and application of submental island flap to reconstruct non-circumferential defect after hypopharyngeal carcinoma resection: a prospective study of 27 cases. Acta Otolaryngol. 2020 Dec;140(12):1036-1042. doi: 10.1080/00016489.2020.1804614. Epub 2020 Aug 18.

    PMID: 32808843RESULT

Study Officials

  • Xiaoming Huang, MD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renhui Chen, MD

CONTACT

+862081332587chenrh23@mail.sysu.edu.cn

Liushan Ou, MD

CONTACT

+8681332587sys_iit@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

December 8, 2023

Study Start

February 16, 2023

Primary Completion (Estimated)

February 16, 2028

Study Completion (Estimated)

February 16, 2030

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)