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

Phase 1

• Conditions: Pancreatic cystic lesions; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-005536-17-ES
• Lead Sponsor: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-06
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 218

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified