The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive JaundiceNCT04620577
The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice
An observational study of The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice, run by Xian-Jun Yu at 1 site in China.
Trial summary
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice
- What is being tested?
- antibiotic
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with periampullary carcinoma and pancreatic head carcinoma who received PTCD drainage.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Xian-Jun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Wen-Quan Wang, M.D., Ph.D., +86-21-6417-5590, wangwenquan@fudanpci.org
About this study
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.
Read the 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.
- Being tested
- antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibioticOther
normal saline
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic group | Infusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD. Receives: Other: antibiotic | |
| No-antibiotic group | Infusion of Normal saline within 1h before and 12h after PTCD. Receives: Other: antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with biliary tract infection after surgery
Incidence of patients with biliary tract infection after surgery
Measured: October 2020 to June 2023
Secondary outcomes (1)
Decline rate of bilirubin in patients after PTCD
Decline rate of bilirubin in patients after PTCD
Measured: October 2020 to June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start20 Oct 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xian-Jun Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620577
- Sponsor's protocol ID
- FudanU
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT04620577
- Acronym / sponsor ID
- FudanU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xian-Jun YuUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic group | – | Other: antibioticInfusion of ceftriaxone sodium needle (2g, solvent 100ml normal saline) within 1h before and 12h after PTCD. |
| No-antibiotic group | – | Other: antibioticInfusion of Normal saline within 1h before and 12h after PTCD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with periampullary carcinoma and pancreatic head carcinoma who received PTCD drainage.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibioticnormal saline | Other | Antibiotic group, No-antibiotic group |
Primary outcome
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
1 secondary outcome
Decline rate of bilirubin in patients after PTCD
Time frame: October 2020 to June 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice, run by Xian-Jun Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, PhD (18019112906, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with biliary tract infection after surgery (time frame: October 2020 to June 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.