Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 3/17/2019 |
| Start Date: | February 2013 |
| End Date: | May 2019 |
| Contact: | Udayakumer Navaneethan, MD |
| Email: | udayakumar.navaneethan.MD@flhosp.org |
| Phone: | 407-303-2570 |
Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)
This study will test two different methods for processing biopsy specimens taken from the
bile duct. Patient;s who are asked to participate int his study have a stricture in the bile
duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde
cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes
performing single operator cholangioscopy-guided biopsies in the bile duct and sending the
tissue to the lab for testing to make a diagnosis. Using this method the investigators can
establish a diagnosis only about 50% of the time. The investigators believe that if a
cytopathologist is available in the endoscopy suite during the procedure to evaluate the
biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose
of this study is to compare two methods for processing biopsies obtained from the bile duct
(Onsite vs. Offsite).
bile duct. Patient;s who are asked to participate int his study have a stricture in the bile
duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde
cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes
performing single operator cholangioscopy-guided biopsies in the bile duct and sending the
tissue to the lab for testing to make a diagnosis. Using this method the investigators can
establish a diagnosis only about 50% of the time. The investigators believe that if a
cytopathologist is available in the endoscopy suite during the procedure to evaluate the
biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose
of this study is to compare two methods for processing biopsies obtained from the bile duct
(Onsite vs. Offsite).
The diagnostic accuracy rate of single operator cholangioscopy-guided biopsy is only 50%.
This translates to the need for performing repeat procedures to establish a diagnosis and
therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are
usually processed offsite in the pathology lab. We believe that if a pathologist can assess
the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic
accuracy rate will improve. This translates to better (faster) diagnosis and early treatment.
Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy
specimens to determine which method yields a better diagnosis.
This translates to the need for performing repeat procedures to establish a diagnosis and
therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are
usually processed offsite in the pathology lab. We believe that if a pathologist can assess
the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic
accuracy rate will improve. This translates to better (faster) diagnosis and early treatment.
Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy
specimens to determine which method yields a better diagnosis.
Inclusion Criteria:
- Age > 18 years
- Suspected biliary stricture
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Altered surgical anatomy
- Irreversible elevation in INR > 1.5 or low platelet count < 50,000
We found this trial at
1
site
601 E Rollins St
Orlando, Florida 32803
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Shyam Varadarajulu, MD
Phone: 407-303-2570
Florida Hospital Florida Hospital is one of the country
Click here to add this to my saved trials
