25 Clinical Trials for Various Conditions
The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds \<2 minutes to ERCP and only associated risk is increased procedure duration). The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures. Primary aim: To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. Secondary aims: 1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used. 2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.
Differentiating malignant from benign bile duct strictures is a conundrum, since no diagnostic test is highly sensitive for diagnosing cancer. While ERCP is effective in palliating obstructive jaundice, standard diagnostic tools in ERCP have a low diagnostic sensitivity and confirm the stricture's etiology in \<50% of cases. During the first ERCP, standard practice is to obtain routine cytology (RC) using a single brush sample. If this is not diagnostic, patients often undergo repeat ERCP, endoscopic ultrasound or other, increasing health care costs. The incremental yield of performing alternate ERCP-based diagnostic tools during the first ERCP including fluorescence in situ hybridization (FISH), cholangioscopy w/biopsy and multiple brushes for routine cytology is currently unknown. There are no studies quantifying the amount of testing utilized to firmly diagnose the etiology of the stricture, or the most efficient combination of diagnostic tools during the first ERCP. These are important knowledge deficiencies since a definitive tissue diagnosis during the first ERCP could reduce the need for downstream tests and expedite treatment, thereby improving patient-centered and economic outcomes. The added costs of using multiple tools during the first ERCP may be offset by these benefits. Among patients with indeterminate bile duct strictures, the investigators hypothesize that a multimodality approach will be more sensitive without a significant reduction in specificity compared to multiple brush samples for routine cytology. The investigators will test this hypothesis using an experimental trial design by randomizing patients during their first ERCP to multiple brushing samples for cytology vs. a single brush sample for cytology + FISH + cholangioscopy w/biopsy. To obtain preliminary data for a definitive multi-center trial, the investigators propose a pilot and feasibility study to compare the performance characteristics of each approach by evaluating the prospective clinical course, including treatment delay, quality of life, and life expectancy for each enrolled patient. If our hypothesis is validated in a subsequent definitive study, the standard approach to tissue sampling during the first ERCP may be altered.
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities. The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days. Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months. Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent. The stent which is star shaped in cross section, channels fluid along its winged perimeter. It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents. The primary aim of this study is to prospectively evaluate the patency rate of the WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.
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).
The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.
The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.
Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram will identify and risk stratify patients for the presence of CBD stones and strictures.
When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.
Plastic biliary stents which are a new larger size will remain free of obstructions for a longer period of time than currently used 10 French stents in cancer in the common bile duct.
The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research. Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.
This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.
Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during routine ERCP, there are few data on the topic of "air" or "CO2" cholangiography. Our primary aim is to compare radiographic cholangiograms in patients with biliary tract disease (from stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs. conventional iodinated contrast.
Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. A randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. In photodynamic therapy (PDT) the uniform distribution of externally applied light is desirable but often difficult to achieve. An optical fiber tip producing cylindrical or lateral light emission can facilitate the application of laser energy by direct implantation of the tip into solid tumors. However, currently used FDA approved glass diffusers used in standard of care PDT might break in the bile ducts causing injury since they are not meant to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used via a choledochoscope. We aim to add to the clinical evidence by conducting an open label observational study trial using this fiber optic diffuser during photo dynamic therapy in the bile ducts.
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies. This multi-center registry has been initiated: * To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies. * To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures. Design is retrospective and prospective registry study. Procedures that will be captured include: 1. EUS-Coils placement 2. EUS Glue injection 3. EUS-Fiducial placement 4. EUS-Neurolysis 5. EUS-Stent placement 6. EUS-alcohol injection 7. EUS-fluid collection, abscess or cavity drainage 8. EUS guided ductal drainage 9. EUS-guided Ablation 10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.