Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Study Overview
=================
Brief Summary
-----------------
Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Detailed Description
-----------------
Objective: To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed. Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not. Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.

Official Title
-----------------
Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Conditions
-----------------
Esophageal Achalasia

Intervention / Treatment
-----------------
* Drug: no antibiotic prophylaxis
* Drug: second-generation cephalosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of esophageal achalasia Ready to have the treatment as POEM and no contraindication of POEM Ability to get informed consent Exclusion Criteria: Patients who had indications for antibiotic prophylaxis as determined by the American Society for Gastrointestinal Endoscopy Patients who had received antibiotics for any reason within the previous 7days Patients who had possible signs of any infection at the time of the procedure Patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: no antibiotic prophylaxis<br>These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. | Drug: no antibiotic prophylaxis<br>* These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.<br>|
| Active Comparator: second-generation cephalosporin<br>These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. | Drug: second-generation cephalosporin<br>* These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood culture positive incidence | To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis. | after 12 hours of POEM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procalcitonin level | To observe the changes of procalcitonin levels after POEM in which no antibiotic is administered. To compare the procalcitonin levels between antibiotic prophylaxis and no antibiotic prophylaxis. | after 12 hours of POEM | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels