A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

NCT ID: NCT05432219

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Recurrent Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Transoral Retropterygoid Nasopharyngectomy

a novel endoscopic approach to resect nasopharyngeal carcinoma

Group Type EXPERIMENTAL

endoscopic surgery

Intervention Type PROCEDURE

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

Interventions

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endoscopic surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongmeng Yu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye&ENT Hospital, Fudan University

Central Contacts

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Kun Du, MD,PhD

Role: CONTACT

+8618321921664

Other Identifiers

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rNPC-SA-ETORP-V1

Identifier Type: -

Identifier Source: org_study_id

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