Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus

Trial Title: Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus

NCT ID: NCT05614375

Condition: Sarcoma,Soft Tissue
Nasal Cavity Cancer
Paranasal Sinus Cancer
Surgery

Conditions: Official terms:
Sarcoma
Paranasal Sinus Neoplasms

Conditions: Keywords:
soft tissue sarcoma
nasal cavity and paranasal sinus
endoscopic surgery
prognose
overall survival rate
outcome
quality of life

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: endoscopic surgery
Description: transnasal endoscopic surgery
Arm group label: soft tissue sarcoma with endoscopic surgery

Summary: Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis. The pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients. Surgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research. The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.

Detailed description: The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.This study is divided into a screening period, a treatment period, and a follow-up period. All subjects need to sign an informed consent form before screening, perform relevant blood tests, imaging examinations, and compare the inclusion and exclusion criteria to select suitable patients to enter the treatment period. The follow-up period is 5 years.

Criteria for eligibility:

Study pop:
For patients diagnosed with STS in the nasal cavity and paranasal sinuses through pathology, appropriate subjects will be selected according to the selection criteria and exclusion criteria of the protocol design.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Sign the informed consent form; 2. STS of nasal cavity and paranasal sinuses diagnosed pathologically; 3. General physical condition can tolerate endoscopic sinus surgery; 4. There is no distant transfer; 5. The research team must believe that the patient can be completely removed by surgery; 6. Good organ function; Exclusion Criteria: 1. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction; 2. Suffer from uncontrolled concurrent diseases; 3. There is a serious neurological or mental illness, including dementia and epileptic seizures; 4. Uncontrolled active infection; 5. There are any other circumstances that may hinder the compliance of the research; 6. Women who are pregnant or breastfeeding.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Yu Hongmeng

Address:
City: Shanghai
Zip: 200031
Country: China

Status: Recruiting

Contact:
Last name: hongmeng Yu, doctor

Phone: 13501730576
Email: hongmengyush@fudan.edu.cn

Contact backup:
Last name: Kai Xue, doctor

Start date: June 12, 2021

Completion date: June 12, 2026

Lead sponsor:
Agency: Eye & ENT Hospital of Fudan University
Agency class: Other

Source: Eye & ENT Hospital of Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05614375