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

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

• Registration Number: NCT04620577
• Lead Sponsor: Xian-Jun Yu

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-10-20
• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-09
• Last Update Posted: 2020-11-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antibiotic group	antibiotic	Infusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD.
No-antibiotic group	antibiotic	Infusion of Normal saline within 1h before and 12h after PTCD.

Primary Outcome Measures

Name	Time	Method
Incidence of patients with biliary tract infection after surgery	October 2020 to June 2023	Incidence of patients with biliary tract infection after surgery

Secondary Outcome Measures

Name	Time	Method
Decline rate of bilirubin in patients after PTCD	October 2020 to June 2023	Decline rate of bilirubin in patients after PTCD

Trial Locations

Locations (1)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China