Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01227382
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Duration (Months): 101.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

Condition or Disease	Intervention/Treatment	Phase
Accuracy of Tissue Diagnosis; Bile Duct Stricture; Pancreatic Duct Stricture	Procedure: ERCP with cholangiopancreatoscopy	N/A

Detailed Description

The participants will undergo an Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy and evaluation of a bile duct or pancreatic duct stricture with three different types of techniques for biopsy: SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Prospective Evaluation of the Accuracy of Spybite Biopsy Forceps for the Tissue Diagnosis of Lesion of the Pancreatobiliary System. ( Part of the "The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Treatment of Pancreaticobiliary Disorders" Study)
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: ERCP with Cholangiopancreatoscopy The subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct or pancreatic duct stricture sampling.	Procedure: ERCP with cholangiopancreatoscopy; Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps; Other Names: Endoscopic Retrograde Cholangiopancreatography ERCP

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Accurate Diagnoses of Cancer [up to 7 days after the procedure]

   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.

Secondary Outcome Measures

1. Procedure Technical Success [day 1]

   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.

2. Total Procedure Time [120 minutes]

   The total time to perform ERCP

3. Total Cholangioscopy Time [60 minutes]

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

4. Cholangioscopy Visualization Time [30 minutes]

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

5. Sampling Times for Each Device [15 minutes]

   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).

6. Adverse Events [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects is 18 years or older

2. Scheduled to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) wiht cholangioscopy and/or pancreatoscopy at the University of Florida Gainesville Florida as medically indicated.

3. Lesion of the pancreatobiliary system that requires tissue sampling as medically indicated

4. Subject myst be able to give informed consent

Exclusion Criteria:

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)

2. The subject is unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shands at UF Ensopcopy	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Peter Draganov, MD, University of Flordia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01227382
• Other Study ID Numbers: SpyBite
• First Posted: Oct 25, 2010
• Last Update Posted: Aug 3, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Disease; Constriction, Pathologic

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.92 (13.37)
Sex: Female, Male (Count of Participants)
Female	11 42.3%
Male	15 57.7%
Region of Enrollment (participants) [Number]
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Accurate Diagnoses of Cancer
Description	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.
Time Frame	up to 7 days after the procedure

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the
Arm/Group Description	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.
Measure Participants	26
Cytology brush	38.5
Standard forceps biopsy	53.9
Spybite biopsy	84.6

2. Secondary Outcome

Title	Procedure Technical Success
Description	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.
Time Frame	day 1

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Measure Participants	26
Number [participants]	26 100%

3. Secondary Outcome

Title	Total Procedure Time
Description	The total time to perform ERCP
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	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.
Measure Participants	26
Mean (Standard Deviation) [minutes]	54.00 (12.71)

4. Secondary Outcome

Title	Total Cholangioscopy Time
Description	This is the total time it takes for the dye to be performed during the ERCP.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	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.
Measure Participants	26
Mean (Standard Deviation) [minutes]	23.65 (9.43)

5. Secondary Outcome

Title	Cholangioscopy Visualization Time
Description	The portion of the total ERCP time spent on Cholangioscopy visualization.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Measure Participants	26
Mean (Standard Deviation) [minutes]	11.69 (8.03)

6. Secondary Outcome

Title	Sampling Times for Each Device
Description	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).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	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.
Measure Participants	26
Spybite forceps	11.92 (4.67)
Standard cytology brushing	3.77 (1.21)
Standard forceps biopsy	5.73 (3.11)

7. Secondary Outcome

Title	Adverse Events
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Percentage of participants with accurate diagnoses of cancer

Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
Measure Participants	26
Number [participants]	3 11.5%

Adverse Events

Time Frame	2 days
Arm/Group Title	Indeterminate Biliary Lesions Requiring Tissue Sampling
Arm/Group Description	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.
All Cause Mortality
	Indeterminate Biliary Lesions Requiring Tissue Sampling
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Indeterminate Biliary Lesions Requiring Tissue Sampling
	Affected / at Risk (%)	# Events
Total	1/26 (3.8%)
Gastrointestinal disorders
Postsphincterotomy Bleeding	1/26 (3.8%)
Other (Not Including Serious) Adverse Events
	Indeterminate Biliary Lesions Requiring Tissue Sampling
	Affected / at Risk (%)	# Events
Total	2/26 (7.7%)
Gastrointestinal disorders
Mild Pancreatitis	2/26 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.