The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

Xian-Jun Yu

Status: Unknown

Conditions: The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

Treatments: Other: antibiotic

Study type: Observational

Funder types: Other

Identifiers

NCT04620577

FudanU

Details and patient eligibility

About

To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.

Full description

This project designed a large-scale, single-center, prospective randomized controlled clinical trial to explore the impact of antibiotics on the incidence of biliary tract infections after PTCD with malignant obstructive jaundice. This study will provide evidence-based medical evidence for the need for routine use of antibiotics to prevent biliary tract infections after PTCD with malignant obstructive jaundice, and provide references for clinicians to prevent patients from PTCD infections.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-80 years old;
2. ECOG score 0-1 before operation;
3. Patients diagnosed as pancreatic head cancer and periampullary cancer according to preoperative imaging, including ampullary cancer, extrahepatic bile duct cancer and duodenal papillary cancer;
4. Bilirubin>200 mmol/L before PTCD , and the duration of PTCD continuous drainage >2 weeks;
5. Volunteer to participate and sign the informed consent form;

Exclusion criteria

1. Decompensated liver cirrhosis, acute and chronic hepatitis and other diseases before surgery;
2. A history of other malignant tumors before surgery;
3. Duration of preoperative PTCD drainage<2 weeks;
4. Jaundice caused by other reasons besides cancer around the ampulla and cancer of the head of the pancreas;

Trial design

120 participants in 2 patient groups

Antibiotic group

Description:

Infusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD.

Treatment:

Other: antibiotic

No-antibiotic group

Description:

Infusion of Normal saline within 1h before and 12h after PTCD.

Treatment:

Other: antibiotic