Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Esophageal Achalasia Clinical Trial

Official title:

Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01750385
• Other study ID #: B2012-089
• Status: Active, not recruiting
• Phase: N/A
• First received: November 20, 2012
• Last updated: December 12, 2012
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2012
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Esophageal Achalasia

Intervention

Drug:
• no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
• second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical manifestation	To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.	during hospital stay and up to 1 week	Yes
Primary	Blood culture positive incidence	To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.	after 12 hours of POEM	Yes
Secondary	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	Yes