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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: antibiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old; ECOG score 0-1 before operation; Patients diagnosed as pancreatic head cancer and periampullary cancer according to preoperative imaging, including ampullary cancer, extrahepatic bile duct cancer and duodenal papillary cancer; Bilirubin>200 mmol/L before PTCD , and the duration of PTCD continuous drainage >2 weeks; Volunteer to participate and sign the informed consent form; Exclusion Criteria: Decompensated liver cirrhosis, acute and chronic hepatitis and other diseases before surgery; A history of other malignant tumors before surgery; Duration of preoperative PTCD drainage<2 weeks; Jaundice caused by other reasons besides cancer around the ampulla and cancer of the head of the pancreas;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antibiotic group<br>Infusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD. | Other: antibiotic<br>* normal saline<br>|
| No-antibiotic group<br>Infusion of Normal saline within 1h before and 12h after PTCD. | Other: antibiotic<br>* normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients with biliary tract infection after surgery | Incidence of patients with biliary tract infection after surgery | October 2020 to June 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline rate of bilirubin in patients after PTCD | Decline rate of bilirubin in patients after PTCD | October 2020 to June 2023 |