Risk of Microbial Translocation in Patients Undergoing Per-Oral Endoscopic Myotomy (POEM) for Achalasia: Antibiotic Prophylaxis or Short-therapy

NCT ID: NCT03587337

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2019-06-30

Brief Summary

Background: Achalasia is a primary rare esophageal motor disorder of the esophagus (annual incidence of 1:100,000 persons). Recently, a new endoscopic technique, Per-Oral Endoscopic Myotomy (POEM), has been introduced with excellent success rates. Several studies have evaluated complications of POEM but there is a lack of knowledge on the potential risk of bacteremia or microbial translocation during the endoscopic intervention and, also, there aren't evidences regarding the use of antibiotics before/after POEM. Microbial translocation (MT) is the passage of both viable and nonviable microbes across the anatomically intact GI barrier to the mesenteric lymph nodes, and possibly other tissues. Gram-negative bacteria contain lipopolysaccharides (LPSs) coating their thin peptidoglycan cell wall. The presence of LPS, an endotoxin, in the plasma has been correlated to sepsis and septic shock through the activation of the inflammatory host defence via binding to soluble CD14 (sCD14) which initiates downstream cytokines (like IL-6, IL-8 and tumor necrosis factor (TNF-α)) and, also, through the production of sCD14 and LPS-binding protein (LBP) by the innate immune system.

Objectives: Considering POEM a clean-contaminated procedure, it should be assessed whether the post-POEM fever or systemic inflammation is a cytokinin-mediated or an infection-related fever. Thus, aim of the study is to evaluate the presence of inflammation mediators, bacteremia and microbial translocation post POEM, to guide future antibiotic prophylaxis/therapy in patients undergoing this procedure.

Methods: All patients who will undergo POEM at _Investigator's Department from June 2017 to June 2019 will be enrolled in a prospective, interventional randomized clinical trial (RCT). Patients will be randomized in two groups. The Group A, prophylaxis group, will receive antibiotics (Cefazolin 2 gr i.v.) only before procedure whereas Group B, short therapy group, will receive antibiotics before POEM (Cefazolin 2 gr i.v.), continued for the first 24 hours and then per os (Amoxicilline/Clavulanic Acid 3 gr/die) for 3 days. For each patient we will be evaluated: dosage of IL-6, IL-1β, TNF-α, sCD4, LPB, LPS and blood cultures.

Expected results: we expect that the prophylaxis group vs short therapy group, has a prevalence of fever and/or systemic inflammation not higher than 10% difference of the fever related to the procedure.

Conditions

Achalasia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Prophylaxis

POEM

Intervention Type: OTHER

Pt. are going to submit a POEM procedure.

Antibiotic tp

POEM

Intervention Type: OTHER

Pt. are going to submit a POEM procedure.

Interventions

POEM

Pt. are going to submit a POEM procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with had a diagnosis of achalasia defined by symptoms,HR manometry and X-ray accordingly to guidelines,who have no absolute contraindications to undergo interventions under general anesthesia
• age over 18 years old
• ability to provide and to give informed consent
• body temperature under 37°C on the day before and just before POEM

Exclusion Criteria

• antibiotic use within 1 week before the procedure
• patients who had chronic inflammatory diseases (such as rheumatic arthritis or inflammatory bowel diseseas) and/or known neoplasia
• inability to obtain written informed consent
• patient unwilling to take part in the study
• impossibility to be subjected to the invasive endoscopic procedure or general anesthesia for the presence of comorbidities
• known allergy to drugs provided in the study protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Countries

Italy

References

Maselli R, Oliva A, Badalamenti M, Galtieri PA, Belletrutti PJ, Spadaccini M, Nicoletti R, Finati E, Vetrano S, Fosso F, Correale C, Pellegatta G, Hassan C, Repici A. Single-dose versus short-course prophylactic antibiotics for peroral endoscopic myotomy: a randomized controlled trial. Gastrointest Endosc. 2021 Nov;94(5):922-929. doi: 10.1016/j.gie.2021.05.045. Epub 2021 Jun 11.

Reference Type: DERIVED

PMID: 34119499 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1789

Identifier Type: -

Identifier Source: org_study_id