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

NCT03587337 | Completed

• 1 other identifier: 1789
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

Per-Oral Endoscopy Myotomy; Microbial Translocation

Outcome Measures

Primary Outcomes (1)

• Presence of inflammation mediators, bacteremia and micro translocation

  Assesment of fever (TC\>38°C) and systemic inflammation (increased in white blood cells (WBC) and/or protein C-reactive (PCR)) that may occur following POEM

  18 Months

Study Arms (2)

Prophylaxis

Other: POEM

Antibiotic tp

Other: POEM

Interventions

POEM OTHER

Pt. are going to submit a POEM procedure.

Antibiotic tp; Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population: patients older than 18, with esophageal achalasia (diagnosed accordingly to the international guidelines) scheduled for POEM, who are willing to participate in a RCT and who are able able to give informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 34119499 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: July 16, 2018
• Study Start: June 14, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 10, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)