Symptoms and General Pathology

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Constriction, Pathologic

Calculi

Gallstones

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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

Hematinics

All Drugs and Chemicals

Gastrointestinal Agents

Pharmaceutical Solutions

Liver Extracts

Pancrelipase

Pancreatin

Sclerosing Solutions

This group is confirmed by DSOC videos from patients with DSOC-confirmed neoplastic bile duct lesions, coming from each participating group. Each DSOC video corresponds to a complete DSOC procedure in a single patient. The neoplastic bile duct criteria are in accordance with the two following tools: the Robles-Medranda et al and the Mendoza classification. A further follow will be necessary to confirm neoplastic bile duct lesion and the type: pCCA or dCCA, local extension of iCCA, hepatocarcinoma mixed CCA/hepatocarcinoma, gallbladder cancer, pancreas cancer, or any other neoplastic bile duct lesion. Based on follow-up, videos from patients with confirmed non-neoplastic bile duct lesions will be re-assessed and re-classified or finally excluded by an expert blinded to clinical records and who do not participate in videos classification.

This group is confirmed by DSOC videos from patients with DSOC-confirmed non-neoplastic bile duct lesions, coming from each participating group. Each DSOC video corresponds to a complete DSOC procedure in a single patient. The non-neoplastic bile duct criteria are in accordance with the two following tools: the Robles-Medranda et al and the Mendoza classification. A further follow will be necessary to confirm non-neoplastic bile duct lesion and the type, when available: acute or chronic cholangitis secondary to stones or parasite's location, autoimmune cholestatic liver diseases as autoimmune sclerosant cholangitis, and primary biliary cholangitis. Based on follow-up, videos from patients with confirmed neoplastic bile duct lesions will be re-assessed and re-classified or finally excluded by an expert blinded to clinical records and who do not participate in videos classification.

AIWorks is an artificial intelligence model for real-time cholangioscopic detection of neoplastic and non-neoplastic bile duct lesions. It allows you to choose using a video file or a USB camera input as the detection source. Once the input source has been selected, the software performs real-time detection by surrounding the area of interest (i.e., the area with malignancy features) inside a bounding box. All detections made are displayed on the right side of the screen and can also be reviewed afterwards.

AI model classification

Six endoscopists with high DSOC expertise will observe and classify a set of videos among neoplastic or non-neoplastic bile duct lesions following a Bernoulli distribution; blinded to clinical records and should have never attended said patients.

Gastroenterologists from each center, with non-DSOC responsibility, will select DSOC videos and corresponding baseline data. DSOC videos and data will be gathered in one set. Each video represents a full DSOC for a single patient. The patient will be the unit of this study.

The neoplastic bile duct criteria are in accordance with the Robles-Medranda et al and the Mendoza classifications (ie. Irregular mucosa surface, Tortuous and dilated vascularity, Irregular nodulations, Polyps, Ulceration, Honeycomb pattern, etc.). The experts will assess neoplastic bile duct by presence or absence of disaggregated criteria. Likewise, by Boolean logical operators, the statistical software will compute disaggregated answers.

DSOC endoscopist experts' classification

Carlos Robles-Medranda

Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions.

In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.

Distinguishing neoplastic from non-neoplastic bile duct lesions is a challenge for clinicians. Magnetic resonance (MR) and biopsy guided by endoscopic retrograde cholangiopancreatography (ERCP) reached a negative predictive value (NPV) around 50%. On the other hand, Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. DSOC could be even better than DSOC-guided biopsy, which is inconclusive in some cases. However, to date, there is no universally accepted DSOC classification for that purpose. Also, endoscopists' Intra and interobserver agreements vary widely. Therefore, a more reproducible system is still needed.

With interesting results, Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools has been developed based on imaging radiomics. Nevertheless, CCA AI resources are almost exclusively for intrahepatic CCA (iCCA), with an endoscopic technique. Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. Perihilar (pCCA) and distal (dCCA) cholangiocarcinoma as the most typical neoplastic bile duct lesions. Both represent 50-60% and 20-30% of all CCA, including secondary malignancies by local extension (hepatocarcinoma, gallbladder, and pancreas cancer).

A recent Portuguese proof-of-concept study developed an AI tool based on convolutional neuronal networks (CNNs). It let to differentiate between malignant from benign bile duct lesions or normal tissue with very high accuracy. Still, it needs more external validation, including endoscopists' Intra and interobserver agreement comparison. In Ecuador, the investigators recently proposed an AI model to classify bile duct lesions during real-time DSOC, which has been able to detect malignancy pattern in all cases.

This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with six endoscopists with high DSOC experience.

Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis

Clinical Validation of an Artificial Intelligence Software for Digital Cholangioscopy Diagnosis: an Observational Trial

Cases will be first followed up during one year to confirm or discard neoplastic bile duct lesions. A definite diagnosis of neoplastic bile duct lesion will be based on DSOC-guided biopsy specimen or findings from further indicated procedures, including brush cytology fluoroscopy-guided, endoscopic ultrasound-guided tissue sampling, surgical samples, and even imaging test in the context of a more impaired patient. Finally, the agreement between one-year follow-up (gold standard) vs. AI model and DSOC endoscopist experts' classification will be verified through a 2 x 2 contingency table.

The Methodist Hospital Research Institute

University of Sao Paulo

Vrije Universiteit Brussel

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Baylor St. Luke's Medical Center

Universitair Ziekenhuis Brussel

Instituto Ecuatoriano de Enfermedades Digestivas

Dilatation, Pathologic

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.

Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.

An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.

Dexamethasone 4mg

Muhammad Nabeel Shafqat

Najam us Sehar Saeed, FCPS

Najam us Sehar Saeed, FCPS-Gastro

The main aim of this clinical trial is to evaluate the effects of dexamethasone on common bile duct cannulation time during endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary pathologies. The study will also study the effects of dexamethasone on total procedure time and total fluoroscopy time during ERCP.

Participants will be divided into two groups, treatment group and placebo group. Patients in treatment group will receive dexamethasone and those in placebo group will be given normal saline before undergoing ERCP. The results in both groups will be compared to determine the effects of dexamethasone.

Effects of Dexamethasone on Common Bile Duct Cannulation Time

Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone

To determine the effects of dexamethasone on shortening of CBD cannulation time

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
Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis	NCT05147389	Common Bile Duc... Non-Neoplastic ...	AI model classi... DSOC endoscopis...	18 Years - 79 Years	Instituto Ecuatoriano de Enfermedades Digestivas
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
Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis	NCT05147389	Common Bile Duc... Non-Neoplastic ...	AI model classi... DSOC endoscopis...	18 Years - 79 Years	Instituto Ecuatoriano de Enfermedades Digestivas
Effects of Dexamethasone on Common Bile Duct Cannulation Time	NCT05945797	Common Bile Duc... Common Bile Duc... Common Bile Duc... Common Bile Duc... Common Bile Duc...	Dexamethasone 4...	18 Years -	Gujranwala medical college District Headquarters Hospital, Gujranwala

Spots Global Cancer Trial Database for common bile duct neoplasms