Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01750385

Enrollment

Registered

2012-12-17

Start date

2012-10-31

Completion date

2013-08-31

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Achalasia

Keywords

Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels

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.

Interventions

DRUGno antibiotic prophylaxis

These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.

DRUGsecond-generation cephalosporin

These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
procalcitonin level	after 12 hours of POEM	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.

Other

Measure	Time frame	Description
clinical manifestation	during hospital stay and up to 1 week	To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026