Clinical trial NCT06437964: Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding
Official title: The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Hypertension, Portal
Variceal Hemorrhage
Keywords: Gastroesophageal Variceal Bleeding
Endoscopic Secondary Prevention
Prophylactic Antibiotics
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. It's 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, it's 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.

Eligibility criteria: Inclusion Criteria:

Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form.

Exclusion Criteria:

1. Allergy to cephalosporin.
2. The patient is unwilling to sign the informed consent form.
3. Already have concurrent infection before the endoscopic operation.
4. Already have fever (body temperature \> 37.5 ℃) before the endoscopic operation.
5. Have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/L) before the endoscopic operation.
6. Have massive pleural effusion or ascites before the endoscopic operation.

Primary outcomes:
measure: Post-operation infection
timeFrame: From the endoscopic operation to hospital discharge
Secondary outcomes:
measure: Post-operation 4-week rebleeding
timeFrame: Within 4 weeks since the endoscopic operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, ZhejiangUniversity
name: Meng Xue, PhD
role: PRINCIPAL_INVESTIGATOR
References: