Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Cholangiocarcinoma

Biliary Tract Diseases

Constriction, Pathologic

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Bile Duct Cancer

Vinay Chandrasekhara, MD

The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.

Prospective Evaluation of Biliary Tissue Sampling With ERCP

Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique

Number of ERCPs, Radiological studies etc needed before accurate diagnosis

Mayo Clinic

Principal Investigator

Jaundice

Jaundice, Obstructive

Hyperbilirubinemia

Skin Manifestations

Endoscopic Ultrasound-guided Biliary Drainage

Endoscopic Retrograde Cholangiopancreatography

We observe the bile duct through endoscopic ultrasound, then puncture through the gastric or duodenum wall and place a guide wire, expanding along the guide wire, finally place a stent between the bile duct and the stomach or intestine for drainage.

EUS-BD

We use a Duodenoscopy to pass through mouth down to the small opening where the bile duct and pancreatic drain. A small narrow catheter is passed through the scope to gain access to the drainage duct , followed by advancement of a wire deep into the duct. A small cut is made at the bile duct opening to help facilitate a stent placed in the bile duct.

ERCP-BD

Xi WU, M.D.

Xi WU

The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.

A RCT of Low MBO Drainage Strategies

A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies

The interval between the operation day and the occurrence of cholangitis and biliary obstruction

Peking Union Medical College Hospital

associate professor，M.D.

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Lithiasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Theodor Voiosu, MD, PhD

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications).

Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program

the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure

percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Evaluation of Biliary Tissue Sampling With ERCP	NCT04572711	Cholangiopancre... Biliary Strictu... Biliary Tract D... Cholangiocarcin...		18 Years -	Mayo Clinic
A RCT of Low MBO Drainage Strategies	NCT06196164	Jaundice, Obstr... Cholangiopancre... Endoscopic Ultr...	EUS-BD ERCP-BD	18 Years -	Peking Union Medical College Hospital
Prospective Evaluation of Biliary Tissue Sampling With ERCP	NCT04572711	Cholangiopancre... Biliary Strictu... Biliary Tract D... Cholangiocarcin...		18 Years -	Mayo Clinic
Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)	NCT02698137	Cholangiopancre... Common Bile Duc... Biliary Strictu... Bile Duct and P...		18 Years -	Clinical Hospital Colentina
A RCT of Low MBO Drainage Strategies	NCT06196164	Jaundice, Obstr... Cholangiopancre... Endoscopic Ultr...	EUS-BD ERCP-BD	18 Years -	Peking Union Medical College Hospital
Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)	NCT02698137	Cholangiopancre... Common Bile Duc... Biliary Strictu... Bile Duct and P...		18 Years -	Clinical Hospital Colentina

Spots Global Cancer Trial Database for cholangiopancreatography, endoscopic retrograde