Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Ductal

Constriction, Pathologic

Bile Duct Diseases

Choledocholithiasis

Common Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

All patients will undergo endoscopic retrograde cholangiopancreatography (ERCP) that is indicated for suspected or confirmed choledocholithiasis or biliary strictures. "Air" contrast cholangiography using carbon dioxide gas will be performed with standard fluoroscopy and digital subtraction fluoroscopic image capture followed by routine cholangiography using iodinated contrast and standard fluoroscopy. Carbon dioxide (CO2) is routinely used in ERCP procedures and would flow into the biliary tree of patients at the time of ERCP, irrespective of this study's interventions. Digital subtraction image capture is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium.

Carbon dioxide (CO2) will be injected into the biliary tree (which is already exposed to CO2 during routine ERCP) and images will be obtained by using fluoroscopy and digital subtraction imaging (a specific setting on certain fluoroscopy tables).

"Air" contrast cholangiography using carbon dioxide gas

Andrew Y. Wang, MD

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.

It has been recommended that endoscopic retrograde cholangiopancreatography (ERCP) be performed using carbon dioxide (CO2) instead of room air as the infused "air" or gas for luminal insufflation for reasons of improved patient comfort and in case of procedural adverse events (as CO2 is more quickly absorbed by the body and as it can be exhaled via the lungs). Air cholangiograms are often incidentally visible on fluoroscopy (radiographically) during ERCP prior to injection of iodinated contrast into the biliary tree. Despite the information from an air cholangiogram being readily available in many instances, biliary endoscopists and radiologists who read the fluoroscopic images taken during ERCP do not usually comment or interpret the "air" or "CO2" cholangiograms. Consequently, very little data is available on the topic of "air" or "CO2" cholangiography. As a contrast medium for cholangiography, CO2 might be safer than iodinated contrast, which is the standard contrast medium used during ERCP, as iodinated contrast cannot be easily absorbed by the body and as it can be trapped proximal to obstructing biliary stones or strictures and lead to biliary tract infection.

This is a prospective cohort study that will enroll patients undergoing ERCP for suspected choledocholithiasis and/or biliary stricture(s). If they did not participate in this study, these patients would still require an ERCP with CO2 used as the endoscopically insufflated "air" medium. Enrolled patients will undergo an initial cholangiogram with CO2 (injected into the bile ducts) utilizing both conventional fluoroscopy and digital subtraction fluoroscopic imaging, followed by conventional cholangiography using iodinated contrast (injected into the bile ducts). Digital subtraction fluoroscopic imaging is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium. Findings on CO2 cholangiography will be compared to those obtained from pre-procedural abdominal imaging along with the cholangiogram done using iodinated contrast at the time of the ERCP procedures.

Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography

For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.

Fluoroscopy/radiation usage/exposure will be measured for each imaging modality and then compared

University of Virginia

Associate Professor of Medicine

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients who undergo ERCPs with trainee involvement

Patients who undergo ERCPs without any trainee involvement

endoscopic retrograde cholangiopancreatography

ERCP

theodor voiosu, MD, PhD

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.

Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.

data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.

Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

Trainee Involvement in ERCP Risk Score

including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis

Policlinico Gemelli, Rome, Italy

Cantacuzino Clinical Hospital, Bucharest, Romania

Zadar Hospital, Zadar, Croatia

University of Belgrade

UHC Zagreb, Zagreb, Croatia

Oxford University Hospital, Oxford, UK

University of Colorado, Denver, USA

Medical University, Sofia, Bulgaria

Universitaire Ziekenhuizen KU Leuven

ISUL Hospital, Sofia, Bulgaria

Clinical Hospital Colentina

MD, PhD

Cholangiocarcinoma

Cysts

Pancreatic Cyst

Bile Duct Neoplasms

Biliary Tract Neoplasms

Standard echoendoscope will be used and EUS examination will be performed per standard of care.

EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Endoscopic ultrasound examination will be performed.

Endoscopic ultrasound examination

Ji Young Bang, MD MPH

Barbara Broome

This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.

The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope

Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.

The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver).

The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging).

The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform).

Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes.

Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes.

Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.

Duration of procedure between the EndoSound Vision System and standard echoendoscopes.

Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.

Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.

Orlando Health, Inc.

Neoplasm Metastasis

Gallbladder Diseases

Biliary Tract Cancer

Gallbladder Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib

Richard Kim, M.D.

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers

OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.

DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib Monotherapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Richard Kim, MD

Patients that were evaluable for efficacy

Overall Survival (OS) at 6 Months

Disease Control Response (DCR)

Progression Free Survival (PFS)

Overall Study

Infections

Communicable Diseases

Fistula

Intestinal Diseases

Digestive System Fistula

Pathological Conditions, Anatomical

Coagulants

Anti-Infective Agents

Central Nervous System Depressants

Hemostatics

Ethanol

Procedures that will be captured include:

EUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis

Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications

Therapeutic Endoscopic Ultrasound

Michel Kahaleh, MD

The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).

1. To assess the clinical and technical success rates of EUS-Guided interventions
2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.

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.

TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.

Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry

Data will not be made available to other out-of-site researchers

Type, frequency and intensity of adverse events

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Adenoma

Cholangitis

Cholestasis

Cholangitis, Sclerosing

Adenoma, Bile Duct

Papilloma, Intraductal

Cholestasis, Extrahepatic

Primary Sclerosing Cholangitis

Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

Interobserver agreement or Interrater agreement

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.

Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management

Primary Objectives:

1. Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (NPV), sensitivity and specificity.
2. Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
3. Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.

B. Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (Screening and Treatment)

Study Design (2 phase):

* Phase 1: Primary Objective 1 and 2 part of the study will be completed.
* Phase 2: Primary Objective 3 of the study will be conducted within 1 month.

Study Timeline: 3 months post WIRB approval. Sample size: 40 VLE Clips of at least 20 seconds featuring one or more the VLE criteria. All clips will have confirmed diagnosis for accuracy analysis. All clips will be de-identified. All clips will be removed from RedCAP and other secure cloud storage upon completion of study.

Clips will be supplied by NinePoint Medical, the company behind VLE OCT. All VLE clips will be from a dataset of clips collected from adults \> 18 and who underwent Endoscopic retrograde cholangiopancreatography (ERCP) with indeterminate biliary stricture indications. The clips are chosen based on the quality of the clips, duration, final diagnosis and presence of either benign or malignant criteria.

Investigators: Up to 30 Expert and non-expert endoscopists currently using VLE

Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity

Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist

Learning curve using CUSUM analysis to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management proficiently.

NinePoint Medical

Innovative Digestive Health Education and Research Inc

Dermatologic Agents

Antineoplastic Agents

Photosensitizing Agents

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing

Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing

Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing

Self expanding metallic stent (SEMS)

Endoscopic radiofrequency ablation (ERFA)

Photodynamic therapy (PDT)

Huihong Liang, MD

Huihong Liang, Doctorial

Huihong Liang, Doctoral

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia
Trainee Involvement in ERCP Risk Score	NCT04341909	Bile Duct Disea... Pancreas Cancer	ERCP	18 Years -	Clinical Hospital Colentina
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope	NCT06340620	Pancreatic Dise... Pancreatic Canc... Pancreatic Cyst Gastrointestina... Bile Duct Disea... Bile Duct Cance... Lymph Node Dise... Submucosal Tumo... Gastrointestina...	Endoscopic ultr...	18 Years - 100 Years	Orlando Health, Inc.
Single Agent Regorafenib in Refractory Advanced Biliary Cancers	NCT02115542	Cancer of the B...	Regorafenib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05051358	Therapeutic End... Advanced Endosc... Therapeutic End... Interventional ... Interventional ... Gastro-Intestin... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Pancreatic Dise... Bile Duct Disea...	Therapeutic End...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study	NCT03951324	Biliary Strictu... Pancreas Cancer Cholangiocarcin... Bile Duct Cance... Bile Duct Neopl... Bile Duct Neopl... Bile Duct Lesio... Bile Duct Obstr... Bile Duct Disea... Bile Duct Obstr... Bile Duct Steno... Bile Duct Adeno... Pancreatic Duct... Pancreatic Duct... Pancreatic Duct... Pancreatic Duct... Primary Scleros...	Interobserver a...	18 Years -	Innovative Digestive Health Education and Research Inc
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma	NCT01739465	Cholangiocarcin...	Self expanding ... Endoscopic radi... Photodynamic th...	18 Years - 70 Years	Guangzhou Medical University

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