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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04620577
Enrollment
120
Registered
2020-11-09
Start date
2020-10-20
Completion date
2023-06-30
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERantibiotic

normal saline

Sponsors

Xian-Jun Yu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Incidence of patients with biliary tract infection after surgeryOctober 2020 to June 2023Incidence of patients with biliary tract infection after surgery

Secondary

MeasureTime frameDescription
Decline rate of bilirubin in patients after PTCDOctober 2020 to June 2023Decline rate of bilirubin in patients after PTCD

Countries

China

Contacts

Primary ContactXianjun Yu, PhD
yuxianjun@fudanpci.org18019112906
Backup ContactMengqi Liu, MD
liumengqi@fudanpci.org18019112906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026