Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia

Phase 3

• Conditions: Achalasia Cardia
• Interventions: Drug: One dose of Cefo-perazone Sulbactum

• Registration Number: NCT03784365
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.

Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.

Detailed Description

POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.

Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.

Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with Clostridium difficile.

With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All the patient(aged 18-65) who underwent POEM for achalasia cardia.

Exclusion Criteria

• Unwillingness to give written informed consent

  • Patients with multiple co morbidities.
  • Immunocompromised patients /on steroid therapy.
  • Patients with indications for antibiotic prophylaxis (infective endocarditis).
  • Patients who have received antibiotics in the last 1 week .
  • Patients who have possible signs of infection during preparation for POEM

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First group	One dose of Cefo-perazone Sulbactum	This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.
Second group	One dose of Cefo-perazone Sulbactum	This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure

Primary Outcome Measures

Name	Time	Method
Infectious complications associated with POEM	1 month	The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups

Secondary Outcome Measures

Name	Time	Method
Comparison of serum Procalcitonin between the two groups	72 hours	Difference in the mean serum procalcitonin values between both the groups
Comparison of erythrocyte sedimentation rate (ESR) between the two groups	72 hours	Both the groups will be compared for mean ESR at 1-hour
Incidence of positive blood cultures	72 hours	The main secondary outcome is difference in the incidence of positive blood cultures between the two groups
Adverse events associated with administration of intravenous antibiotics	1-month	Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics
Comparison of inflammatory markers (CRP) between the two groups	72 hours	Both the groups will be compared for mean blood C-reactive protein (CRP)

Trial Locations

Locations (1)

Dr.Mohan Ramchandani; 🇮🇳 Hyderabad, RED ROSE Restaurant, India