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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Transoral Retropterygoid Nasopharyngectomy | Experimental | a novel endoscopic approach to resect nasopharyngeal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic surgery | Procedure | endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of a complete resection based on imaging findings | The rate of a complete resection based on postoperative imaging findings | within 7 days after surgery |
| bleeding volume in surgery | The hemorrhage volume during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Du, MD,PhD | Contact | +8618321921664 | dkxuexihao@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, MD,PhD | Eye&ENT Hospital, Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| From the beginning to the end of the surgery |
| Operating time | Duration of operating time | From the beginning to the end of the surgery |
| Surgery-associated restricted mouth opening | The rate of surgery-associated restricted mouth opening | at 30 days post surgery |
| Disease-free survival (DFS) | Duration of the disease-free survival after surgery | 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 | 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 | 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 | 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 | 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 | From the date of surgery to the end of study, up to 2 years. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D013514 | Surgical Procedures, Operative |