Trial Outcomes & Findings for NBI to Detect Post-RT Mucosal Residual NPC (NCT NCT02584790)
NCT ID: NCT02584790
Last Updated: 2017-12-08
Results Overview
4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients. Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Post-radiotherapy 8th week
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
Post Radiotherapy 8 Weeks NPC Patient
All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
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|---|---|
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Overall Study
STARTED
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55
|
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Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Post Radiotherapy 8 Weeks NPC Patient
n=55 Participants
All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
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|---|---|
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Age, Customized
< 18 years old
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0 Participants
n=55 Participants
|
|
Age, Customized
>= 18 years old
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55 Participants
n=55 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=55 Participants
|
|
Region of Enrollment
Hong Kong
|
55 participants
n=55 Participants
|
|
NPC patients
|
40 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Post-radiotherapy 8th week4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients. Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern
Outcome measures
| Measure |
Post Radiotherapy 8 Weeks NPC Patient
n=40 Participants
All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
|
|---|---|
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Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade A, no residual NPC
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14 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade A, positive residual NPC
|
1 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade B, no residual NPC
|
20 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade B, positive residual NPC
|
1 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade C, no residual NPC
|
1 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade C, positive residual NPC
|
1 participants
|
|
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade D, no residual NPC
|
1 participants
|
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Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Grade D, positive residual NPC
|
1 participants
|
SECONDARY outcome
Timeframe: Post-radiotherapy eight weeksPopulation: NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.
Outcome measures
| Measure |
Post Radiotherapy 8 Weeks NPC Patient
n=40 Participants
All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
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|---|---|
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Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
NBI suspicious pattern · without residual disease
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2 Participants
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Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
NBI non suspicious pattern · without residual disease
|
34 Participants
|
|
Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
NBI non suspicious pattern · with residual disease
|
2 Participants
|
|
Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
NBI suspicious pattern · with residual disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Post-radiotherapy eight weeksPopulation: NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.
Outcome measures
| Measure |
Post Radiotherapy 8 Weeks NPC Patient
n=40 Participants
All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
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|---|---|
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The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Sensitivity
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50 Percentage of participants
|
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The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Positive Predicted Valve
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50 Percentage of participants
|
|
The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Specificity
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94 Percentage of participants
|
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The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Negative Predicted Valve
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94 Percentage of participants
|
Adverse Events
Post Radiotherapy 8 Weeks NPC Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Wong Kai Chuen
Pamela Youde Nethersole Eastern Hospital
Phone: (852) 64600771
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place