Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437964
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-26
Brief Title:
Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear In this non-inferiority trial we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding
Detailed Description:
Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding GVB Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding GVB However the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear Its assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding Besides the surface of intraluminal varices is nonsterile and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia As a result its rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB While giving antibiotics in all patients might cause abuse of antibiotics In clinical practice now the prophylactic administration of antibiotics is quite subjective We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding even they have not been administered prophylactic antibiotics In this non-inferiority trial we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None