Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

NCT01750385 | Unknown DMC

• 1 other identifier: B2012-089
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Achalasia

Keywords

Esophageal Achalasia; antibiotic prophylaxis; blood culture; procalcitonin levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• procalcitonin level

  after 12 hours of POEM

Other Outcomes (1)

• clinical manifestation

  during hospital stay and up to 1 week

Study Arms (2)

no antibiotic prophylaxis

ACTIVE COMPARATOR

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

Drug: no antibiotic prophylaxis

second-generation cephalosporin

ACTIVE COMPARATOR

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

Drug: second-generation cephalosporin

Interventions

no antibiotic prophylaxis DRUG

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

no antibiotic prophylaxis

second-generation cephalosporin DRUG

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

second-generation cephalosporin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of esophageal achalasia
• Ready to have the treatment as POEM and no contraindication of POEM
• Ability to get informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Second Generation Cephalosporins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

beta Lactam Antibiotics; Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ping-Hong Zhou, M.D,PhD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 17, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 17, 2012

Record last verified: 2012-12