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

November 3, 2020 updated by: Xian-Jun Yu
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with periampullary carcinoma and pancreatic head carcinoma who received PTCD drainage.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patients with biliary tract infection after surgery
Time Frame: October 2020 to June 2023
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
Time Frame: October 2020 to June 2023
Decline rate of bilirubin in patients after PTCD
October 2020 to June 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xian-Jun Yu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FudanU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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