Use of antibiotic prophylaxis for EUS- FNA of pancreatic cystic lesions

Multicenter, randomized and double-blinded clinical trial on the use of antibiotic prophylaxis for EUS guided FNA of pancreatic cystic lesions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005536-17-ES

Enrollment

218

Registered

2014-06-06

Start date

2014-08-18

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cystic lesions

Interventions

Trade Name: Ciprofloxacino Kabi 2 mg/ml solución para perfusión EFG Pharmaceutical Form: Solution for infusion INN or Proposed INN: CIPROFLOXACIN CAS Number: 85721-33-1 Other descriptive name: CIPROFL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with a pancreatic cyst requiring EUS-FNA to complete evaluation. - Participant is willing and able to give informed consent for participation in the study. - Age 18 years or older. - Ability to understand study procedures and to comply with them for the entire length of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 218 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis). - Cystic lesion of the intestinal wall (foregut or duplication cyst). - Use of antibiotic treatment for any other indication during the 5 days prior to the procedure. - Pregnant woman. - Known allergy/sensitivity to ciprofloxacin. - Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if the EUS-FNA of pancreatic cystic lesions without antimicrobial prophylaxis does not increase the risk of infection compared to the same procedure with antimicrobial prophylaxis.;Secondary Objective: 1. To assess the risk of fever after EUS-FNA of a pancreatic cyst with and without antimicrobial prophylaxis. 2. To assess secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections) 3. To assess other complications of the procedure (bleeding, perforation).;Primary end point(s): Incidence of infection of pancreatic cyst: expressed as a percentage. Infection was defined as "confirmed" positive culture if the content of the lesion or suspected by clinical or imaging techniques (CT, MRI) and no positive blood culture. Be defined as "suspicious" when there is clinical suspicion and / or suggestive image of cyst infection, but laboratory confirmation is obtained.;Timepoint(s) of evaluation of this end point: 21 days	—

Measure

Time frame

Main Objective: To investigate if the EUS-FNA of pancreatic cystic lesions without antimicrobial prophylaxis does not increase the risk of infection compared to the same procedure with antimicrobial prophylaxis.;Secondary Objective: 1. To assess the risk of fever after EUS-FNA of a pancreatic cyst with and without antimicrobial prophylaxis. 2. To assess secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections) 3. To assess other complications of the procedure (bleeding, perforation).;Primary end point(s): Incidence of infection of pancreatic cyst: expressed as a percentage. Infection was defined as "confirmed" positive culture if the content of the lesion or suspected by clinical or imaging techniques (CT, MRI) and no positive blood culture. Be defined as "suspicious" when there is clinical suspicion and / or suggestive image of cyst infection, but laboratory confirmation is obtained.;Timepoint(s) of evaluation of this end point: 21 days

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Secondary

Measure	Time frame
Secondary end point(s): Risk of fever Other complications (as bleeding or perforation) Secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections);Timepoint(s) of evaluation of this end point: The evaluation of the secondary outcomes will be performed during the procedure and all the follow up period (21 days), and the follow up will be extended until it is solved.	—

Measure

Time frame

Secondary end point(s): Risk of fever Other complications (as bleeding or perforation) Secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections);Timepoint(s) of evaluation of this end point: The evaluation of the secondary outcomes will be performed during the procedure and all the follow up period (21 days), and the follow up will be extended until it is solved.

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Countries

Spain

Contacts

Public ContactClinical Trial Assistant

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau

epenag@santpau.cat0034935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026