Skip to main content
OpenTrials
Completed

NCT Number: NCT06437964

Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Withdraw Criteria:

  • The patient turned back after signing the consent, and before the endoscopic operation.
  • Have fever (body temperature > 37.5 ℃) after signing the consent, and before the endoscopic operation.
  • 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.).
  • The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.

Treatment and study plan

No use of prophylactic antibiotics

Other

In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.

Prophylactic Antibiotics

Drug

Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy

Primary outcomes

  1. Postoperative fever

    Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

    Have fever (>37.5℃) in hospital afer the endoscopic operation

Secondary outcomes

  1. Postoperative 4-week rebleeding

    Time frame: Within 4 weeks since the endoscopic operation

    Have gastroesophageal variceal bleeding within 4 weeks after the endoscopic operation

  2. Additional use of antibiotics

    Time frame: From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

    Received additional antibiotics after the endoscopic operation

  3. Postoperative hospital stays

    Time frame: From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.

    Hospital stay (days) after the endoscopic operation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 31, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.