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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620577
• Other study ID #: FudanU
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2020
• Source: Fudan University
• Contact: Xianjun Yu, PhD
• Phone: 18019112906
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cholangitis
• Communicable Diseases
• Infection
• Jaundice
• Jaundice, Obstructive
• The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

Intervention

Other:
• antibiotic
normal saline

Locations

Country	Name	City	State
China	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Jun Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients with biliary tract infection after surgery	Incidence of patients with biliary tract infection after surgery	October 2020 to June 2023
Secondary	Decline rate of bilirubin in patients after PTCD	Decline rate of bilirubin in patients after PTCD	October 2020 to June 2023