A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

NCT05432219 | Unknown

• 1 other identifier: rNPC-SA-ETORP-V1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a a prospective, single-arm, and exploratory study of endoscopic resection of recurrent nasopharyngeal carcinoma via transoral retropterygoid approach.

Conditions

Recurrent Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Margin-negative (R0) resection rate

  The rate of the margin-negative resection of the nasopharyngeal carcinoma

  once the pathology results come out, up to 14 days

Secondary Outcomes (9)

• Rate of a complete resection based on imaging findings

  within 7 days after surgery

• bleeding volume in surgery

  From the beginning to the end of the surgery

• Operating time

  From the beginning to the end of the surgery

• Surgery-associated restricted mouth opening

  at 30 days post surgery

• Disease-free survival (DFS)

  From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years

Study Arms (1)

Endoscopic Transoral Retropterygoid Nasopharyngectomy

EXPERIMENTAL

a novel endoscopic approach to resect nasopharyngeal carcinoma

Procedure: endoscopic surgery

Interventions

endoscopic surgery PROCEDURE

endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach

Endoscopic Transoral Retropterygoid Nasopharyngectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
• AJCC rT2-T4 which can be surgically removed.
• No distant metastasis.
• aged 18 or more than 18 years old.
• With or without lymph node metastasis, which can be surgically removed.
• No severe restricted mouth opening, and oral approach eligible.
• Sufficient organ function.
• With signed informed consent.
• ECOG score 0-2, and general physical condition can tolerate general anesthesia surgery.

You may not qualify if:

• Primary nasopharyngeal carcinoma
• The patient has surgical contraindications: such as severe cardiopulmonary disease and coagulation dysfunction, etc.
• The patient has any situation that may hinder study compliance or the safety during the study period.
• Suffer from uncontrolled disease which could interfere with treatment.
• Uncontrolled active infection.
• Pregnant or breastfeeding women
• There are some other situations that are not suitable for entry into the study.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Chinese Academy of Medical Sciences: collaborator

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hongmeng Yu, MD,PhD

  Eye&ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Du, MD,PhD

CONTACT

+8618321921664; dkxuexihao@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: June 16, 2022
• First Posted: June 27, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 27, 2022

Record last verified: 2022-06