Trial Outcomes & Findings for Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease (NCT NCT01504971)

Results Overview

Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

Recruitment status

UNKNOWN

Target enrollment

95 participants

Primary outcome timeframe

1 month

Results posted on

2015-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Gastroesophageal Reflux Disease (GERD) symptom questionaire: GerdQ questionaire pH monitoring: 24-hour pH monitoring Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI rabeprazole: 10mg, bid, p.o.
Overall Study STARTED	95
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Gastroesophageal Reflux Disease (GERD) symptom questionaire: GerdQ questionaire pH monitoring: 24-hour pH monitoring Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI rabeprazole: 10mg, bid, p.o.
Overall Study Physician Decision	13

Baseline Characteristics

Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastroesophageal Reflux Disease (GERD) n=95 Participants symptom questionaire: GerdQ questionaire pH monitoring: 24-hour pH monitoring Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI rabeprazole: 10mg, bid, p.o.
Age, Continuous	49 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment China	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

Outcome measures

Outcome measures
Measure	Participants n=82 Participants Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease	Participants Same to arm1 n=82 Participants Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease	Participants Same to Previous Arm n=82 Participants Diagnostic capabilities of GerdQ in the diagnosis of GERD
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.	21 percentage of participants Interval 9.0 to 32.0	77 percentage of participants Interval 65.0 to 89.0	60 percentage of participants Interval 45.0 to 74.0

SECONDARY outcome

Timeframe: 1 month

Symptom score is assessed by a self-reported questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 month

Treatment effect of PPI is assessed by changes of symptom score

Outcome measures

Outcome data not reported

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Same to arm1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Same to Previous Arm

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. Weifeng Wang

ChinaPLAGH

Phone: 0086-13911952018

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place