The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice
1 other identifier
observational
120
1 country
1
Brief Summary
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2020
CompletedFirst Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedNovember 9, 2020
November 1, 2020
2.7 years
November 3, 2020
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of patients with biliary tract infection after surgery
Incidence of patients with biliary tract infection after surgery
October 2020 to June 2023
Secondary Outcomes (1)
Decline rate of bilirubin in patients after PTCD
October 2020 to June 2023
Study Arms (2)
Antibiotic group
Infusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD.
No-antibiotic group
Infusion of Normal saline within 1h before and 12h after PTCD.
Interventions
Eligibility Criteria
Patients with periampullary carcinoma and pancreatic head carcinoma who received PTCD drainage.
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xian-Jun Yulead
Study Sites (1)
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President of Shanghai Pancreatic Cancer Institute
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 9, 2020
Study Start
October 20, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
November 9, 2020
Record last verified: 2020-11