Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Constriction, Pathologic

Calculi

Gallstones

Cholelithiasis

Cholecystolithiasis

Cholestasis

Choledocholithiasis

Bile Duct Neoplasms

Common Bile Duct Neoplasms

Pathological Conditions, Anatomical

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Common Bile Duct Diseases

Gallbladder Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures

cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH

cholangioscopy (Frimberger)

Thomas Rösch, Prof. Dr.

Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic precondition. Other than the conventional mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at the side of a specially developed duodenoscope (mother part) which is prepositioned distally to the control unit, near to the patient's mouth. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. This study is designed to test the efficiency of the device in relation to this assumption.

Cholangioscopy is a subsidiary treatment in endoscopic retrograde cholangiopancreaticography (ERCP), used for special issues. In the context of ERCP, a long,thin shaped device is introduced through the working channel of a duodenoscope and then through the papilla into the biliary duct.

Inspection of the biliary duct can be used for tumor biopsies as well as for gall stone lithotripsy by laser or electrohydraulic technique.

Manoeuverability of cholangioscopes is limited by the length of the scope, even more, since most of the device body is stuck in the working channel.

The newly designed cholangioscope by the company of Karl Storz GmbH is introduced through a shortened working channel. Introduction of the cholangioscope is done by an innovative side port for the cholangioscope at 70 cm from the insertion tube's distal end. This leads to a better flexibility of the device tip. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres.

This study is designed to test the efficiency of the device in relation to this assumption.

Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

1. complete lithotripsy in a single session
2. rate of right positive malignoma diagnostics (sensitivity)

Number of complications during examination and during monitoring over 24 hours post procedure

Time of procedure and success of stone extraction in %

Number of biopsies taken. Evaluation of quality of biopsies by pathologists (pathological department of University Hospital Hamburg Eppendorf).

Minimum number of bioptic manoeuvres: 3 Comparison with brush cytology (3 brush manoeuvres with 12 smear preparations) by reference cytologist (Dr. Topalidis, Hannover)

KARL STORZ GmbH & Co. KG, Tuttlingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Rare Diseases

Carcinoma

Carcinoma, Ductal

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones	NCT01683240	Choledocholithi... Common Bile Duc... Cholestasis	cholangioscopy ...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones	NCT01683240	Choledocholithi... Common Bile Duc... Cholestasis	cholangioscopy ...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia

Spots Global Cancer Trial Database for cholangiography