Trial Outcomes & Findings for Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods (NCT NCT01227382)

NCT ID: NCT01227382

Last Updated: 2015-08-03

Results Overview

The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: up to 7 days after the procedure
• Results posted on: 2015-08-03

Participant Flow

Participant milestones

Measure	Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Baseline characteristics by cohort

Measure	Indeterminate Biliary Lesions Requiring Tissue Sampling n=26 Participants Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Age, Continuous	67.92 years STANDARD_DEVIATION 13.37 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 7 days after the procedure

Population: Percentage of participants with accurate diagnoses of cancer

The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Percentage of Participants With Accurate Diagnoses of Cancer Cytology brush	38.5 percentage of accurate diagnoses
Percentage of Participants With Accurate Diagnoses of Cancer Standard forceps biopsy	53.9 percentage of accurate diagnoses
Percentage of Participants With Accurate Diagnoses of Cancer Spybite biopsy	84.6 percentage of accurate diagnoses

SECONDARY outcome

Timeframe: day 1

Population: Percentage of participants with accurate diagnoses of cancer

The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Procedure Technical Success	26 participants

SECONDARY outcome

Timeframe: 120 minutes

Population: Percentage of participants with accurate diagnoses of cancer

The total time to perform ERCP

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Total Procedure Time	54.00 minutes Standard Deviation 12.71

SECONDARY outcome

Timeframe: 60 minutes

Population: Percentage of participants with accurate diagnoses of cancer

This is the total time it takes for the dye to be performed during the ERCP.

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Total Cholangioscopy Time	23.65 minutes Standard Deviation 9.43

SECONDARY outcome

Timeframe: 30 minutes

Population: Percentage of participants with accurate diagnoses of cancer

The portion of the total ERCP time spent on Cholangioscopy visualization.

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Cholangioscopy Visualization Time	11.69 minutes Standard Deviation 8.03

SECONDARY outcome

Timeframe: 15 minutes

Population: Percentage of participants with accurate diagnoses of cancer

The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Sampling Times for Each Device Spybite forceps	11.92 minutes Standard Deviation 4.67
Sampling Times for Each Device Standard cytology brushing	3.77 minutes Standard Deviation 1.21
Sampling Times for Each Device Standard forceps biopsy	5.73 minutes Standard Deviation 3.11

SECONDARY outcome

Timeframe: 24 hours

Population: Percentage of participants with accurate diagnoses of cancer

Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.

Outcome measures

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n=26 Participants Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Adverse Events	3 participants

Adverse Events

Indeterminate Biliary Lesions Requiring Tissue Sampling

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Indeterminate Biliary Lesions Requiring Tissue Sampling n=26 participants at risk Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Gastrointestinal disorders Postsphincterotomy Bleeding	3.8% 1/26 • 2 days

Other adverse events

Measure	Indeterminate Biliary Lesions Requiring Tissue Sampling n=26 participants at risk Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Gastrointestinal disorders Mild Pancreatitis	7.7% 2/26 • 2 days

Additional Information

Dr. Peter V. Draganov

University of Florida

Phone: (352) 273-9472

Email: Peter.Draganov@medicine.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place