Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Biliary Tract Neoplasms

Pancreatic Diseases

Gallbladder Diseases

Choledocholithiasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Endocrine System Diseases

Bile Duct Diseases

Common Bile Duct Diseases

Biliary Tract Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Pancreatic Cancer

Patients will undergo ERCP using a duodenoscope with a single-use distal cover

Patients will undergo ERCP using a conventional duodenoscope

Newer duodenoscope with a single-use distal cover

Duodenoscope with single-use distal cover

Conventional duodenoscope with standard methods of reprocessing

Conventional duodenoscope

Pradeep Siddappa, MD

Siddappa K Siddappa, MD

Subhas Banerjee, MD

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver(1).

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system.

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system.

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy. Each patient's procedure will be assessed on a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Stanford University

Professor of Medicine

Cholangiocarcinoma

Constriction, Pathologic

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Probe-based confocal laser endomicroscopy

Yang Chen, MD, FACP, FACG

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.

This is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.

A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope	NCT05429203	Biliary Disease Pancreatic Dise... Choledocholithi... Biliary Obstruc... Biliary Tract N... Pancreatic Neop...	Duodenoscope wi... Conventional du...	18 Years -	Stanford University
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers	NCT00779688	Pancreatic Canc... Bile Duct Cance...	Probe-based con...	18 Years -	Mauna Kea Technologies

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