Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

Zhejiang University

Status: Active, not recruiting

Conditions: Hypertension, Portal; Cirrhosis, Liver; Variceal Hemorrhage

Treatments: Drug: Prophylactic Antibiotics; Other: No use of prophylactic antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06437964

2024-0629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.

Exclusion criteria

1. Age <18, or ≥81.
2. The patient is unwilling to sign the informed consent form.
3. Allergy to cephalosporin.
4. Have granulocyte deficiency (neutrophil count ≤ 0.5 * 10 ^ 9/L, or white blood cell count ≤ 1.0 * 10 ^ 9/L) before the endoscopic operation.
5. Already have infection or fever (body temperature > 37.5 ℃) before signing the informed consent form.

Withdraw Criteria:

1. The patient turned back after signing the consent, and before the endoscopic operation.
2. Have fever (body temperature > 37.5 ℃) after signing the consent, and before the endoscopic operation.
3. Transferred to other department for additional treatment after the endoscopic operation (Surgical department for malignant tumor, Interventional radiology department for splenic embolism or transjugular intrahepatic portosystemic shunt, etc.).
4. The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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226 participants in 2 patient groups

Prophylactic antibiotics

Active Comparator group

Description:

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

Treatment:

Drug: Prophylactic Antibiotics

No prophylactic antibiotics

Experimental group

Description:

No use of prophylactic antibiotics before endoscopic therapy

Treatment:

Other: No use of prophylactic antibiotics