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A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

E

Eye & ENT Hospital of Fudan University

Status

Not yet enrolling

Conditions

Recurrent Nasopharyngeal Carcinoma

Treatments

Procedure: endoscopic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05432219
rNPC-SA-ETORP-V1

Details and patient eligibility

About

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

Full description

The present study explored a novel transoral retropterygoid approach to resect recurrent nasopharyngeal carcinoma, aiming to investigate the effectiveness of this novel approach in the treatment of recurrent nasopharyngeal carcinoma. The primary end point was the margin-negative (R0) resection rate.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Endoscopic Transoral Retropterygoid Nasopharyngectomy
Experimental group
Description:
a novel endoscopic approach to resect nasopharyngeal carcinoma
Treatment:
Procedure: endoscopic surgery

Trial contacts and locations

0

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Central trial contact

Kun Du, MD,PhD

Data sourced from clinicaltrials.gov

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