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

Sponsor

Xian-Jun Yu (Other)

Overall Status

Recruiting

CT.gov ID

NCT04620577

Collaborator

(none)

120

Enrollment

Location

32.3

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice	Other: antibiotic

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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 20, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Antibiotic group

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

Other: antibiotic

normal saline

No-antibiotic group

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

Other: antibiotic

normal saline

Outcome Measures

Primary Outcome Measures

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

Decline rate of bilirubin in patients after PTCD [October 2020 to June 2023]
Decline rate of bilirubin in patients after PTCD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai	China	200032