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

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ClinicalTrials.gov Identifier: NCT04620577
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

Study Description
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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
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
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Study Type : Observational
Estimated 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 : October 20, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Decline rate of bilirubin in patients after PTCD [ Time Frame: October 2020 to June 2023 ]
    Decline rate of bilirubin in patients after PTCD


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with periampullary carcinoma and pancreatic head carcinoma who received PTCD drainage.
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620577


Contacts
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Contact: Xianjun Yu, PhD 18019112906 yuxianjun@fudanpci.org
Contact: Mengqi Liu, MD 18019112906 liumengqi@fudanpci.org

Locations
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China, Shanghai
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xian-Jun Yu, M.D., Ph.D.    +86-21-6417-5590    yuxianjun@fudanpci.org   
Contact: Wen-Quan Wang, M.D., Ph.D.    +86-21-6417-5590    wangwenquan@fudanpci.org   
Principal Investigator: Xianjun Yu, M.D., Ph.D.         
Sponsors and Collaborators
Xian-Jun Yu
More Information
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Responsible Party: Xian-Jun Yu, President of Shanghai Pancreatic Cancer Institute, Fudan University
ClinicalTrials.gov Identifier: NCT04620577    
Other Study ID Numbers: FudanU
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cholangitis
Jaundice
Jaundice, Obstructive
Disease Attributes
Pathologic Processes
 Hyperbilirubinemia
Skin Manifestations
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents