NCT03587337: POEM-MT01

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

Completed Last updated 10 September 2019

What this trial tests

trial testing POEM in Achalasia in 124 participants. Completed in 30 June 2019.

Timeline

14 June 2017

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Status	Completed
Study type	OBSERVATIONAL
Enrollment	124
Start date	14 June 2017
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across Italy

Drugs / interventions tested

• POEM

Conditions studied

• Achalasia — all drugs for Achalasia →

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Achalasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single-dose versus short-course prophylactic antibiotics for peroral endoscopic myotomy: a randomized controlled trial.
   Maselli R, Oliva A, Badalamenti M, Galtieri PA, et al · · 2021 · cited 16× · PMID 34119499 · DOI 10.1016/j.gie.2021.05.045