Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Cholangiocarcinoma

Constriction, Pathologic

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

cholangiocarcinoma patients without any anti-cancer therapy

benign biliary stricture patients without any therapy targeting the stricture

Lin Miao, MD

Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by many types of cells. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced.Exosomes contain proteins,RNAs and lipid,which may transfer biological information and activities from donor cells to receptor cells. Non-coding RNAs are involved in many biological activities including tumor growth and metastasis.

In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after surgical resection.

ncRNAs in Exosomes of Cholangiocarcinoma

Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients

Characterization of the ncRNAs in tumor derived exosomes from cholangiocarcinoma patients before anti-cancer therapies and benign biliary stricture patients

Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until death) and time-to-event end-points

Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until tumor progression) and time-to-event end-points

The Second Hospital of Nanjing Medical University

Infections

Digestive System Diseases

Communicable Diseases

Klatskin Tumor

Bacteremia

Cholangitis

Choledocholithiasis

Bile Duct Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Common Bile Duct Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Cephalosporins

Cefotaxime

Cefoxitin

Antibiotics, Antitubercular

1\~2g of Cefoxitin (2nd generation cephalosporin) is administered to patients 30 minutes Before ERCP procedure. Cefoxitin is mixed with 10ml of normal saline. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.

Pacetin® (cefoxitin)

10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.

Placebo

Seung Min Bang, MD

Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality.

Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected.

In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.

Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Grade of post-ERCP infectious complications based upon a consensus definition Mild : \>38°C for 24-48 hr / Moderate : Febrile or septic illness requiring more than 3 days of hospital treatment or endoscopic or percutaneous intervention / Severe : Septic shock or surgery

Yonsei University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ncRNAs in Exosomes of Cholangiocarcinoma	NCT03102268	Cholangiocarcin... Benign Biliary ...		18 Years -	The Second Hospital of Nanjing Medical University
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient	NCT02958059	Biliary Obstruc... Benign Biliary ... Peri-ampullary ... Bile Duct Cance... Klatskin Tumor	Pacetin® (cefox... Placebo	19 Years -	Yonsei University

Spots Global Cancer Trial Database for benign biliary stricture