This is a a prospective, single-arm, and exploratory study of endoscopic resection of recurrent nasopharyngeal carcinoma via transoral retropterygoid approach.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach
Margin-negative (R0) resection rate
The rate of the margin-negative resection of the nasopharyngeal carcinoma
Time frame: once the pathology results come out, up to 14 days
Rate of a complete resection based on imaging findings
The rate of a complete resection based on postoperative imaging findings
Time frame: within 7 days after surgery
bleeding volume in surgery
The hemorrhage volume during surgery
Time frame: From the beginning to the end of the surgery
Operating time
Duration of operating time
Time frame: From the beginning to the end of the surgery
Surgery-associated restricted mouth opening
The rate of surgery-associated restricted mouth opening
Time frame: at 30 days post surgery
Disease-free survival (DFS)
Duration of the disease-free survival after surgery
Time frame: From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years
local recurrence-free survival (LRFS)
Duration of the local recurrence-free survival (LRFS) after surgery
Time frame: From the date of enrollment to local recurrence or death, up to 2 years
quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life
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using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response leve
Time frame: From the date of enrollment to the end of study, up to2 years
quality of life-(EORTC QLQ) -H&N35
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H\&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems
Time frame: From the date of enrollment to the end of study, up to 2 years.
surgery-associated adverse effect
Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version 5.0 to evaluate surgery-associated adverse effect
Time frame: From the date of surgery to the end of study, up to 2 years.