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Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia

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ClinicalTrials.gov Identifier: NCT03404739
Recruitment Status : Unknown
Verified January 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:

Peroral endoscopic myotomy is a novel, promising endoscopic technique for achalasia considering its minimal invasive characteristics and comparable efficacy to Heller myotomy. Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM. However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM. Postoperative prophylactic antibiotics are universally initiated on call to the operating room or at the start of POEM and consist of second-generation cephalosporins. The mean duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.

Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of surgical procedures. Other studies have shown that prolonged administration of antibiotics for longer than 24 hours add no benefit in many surgeries. 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.

Thus, investigators intend to perform a prospective randomized study to confirm the validity of single-dose antimicrobial prophylaxis for the prevention of infectious complications following peroral endoscopic myotomy.


Condition or disease Intervention/treatment Phase
Esophageal Achalasia Drug: Saline Solution Drug: Ceftazidime Phase 2 Phase 3

Detailed Description:
This prospective randomized trial is performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of infectious complications associated with peroral endoscopic myotomy. Six hundred sixty-six patients undergoing POEM for achalasia will be randomized to receive only single-dose ceftazidime (2g) or an additional 2 doses every 12 hours postoperatively (multi-dose group). POEM associated infectious complications will be assessed and recorded as regional infections, remote infections and systemic infections. Infection rate, adverse events related to antibiotics and POEM, Clavien-Dindo classification of surgical complications, length of hospital stay and efficacy of POEM will be compared. Body fluid bacterial culture will be conducted in patients suspected of infectious complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single- versus multiple-dose antimicrobial prophylaxis
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Sequentially numbered, opaque sealed envelopes(SNOSE) will be the method to conceal allocation from the study team.
Primary Purpose: Prevention
Official Title: Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia: A Triple-Blind, Randomized Controlled, Non-Inferiority Trial
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: Single-dose group
Ceftazidime 2g at the start of POEM
Drug: Saline Solution
These patients will be given only one dose of ceftazidime at the start of POEM plus 2 doses of saline solution every 12 hours after the procedure.

Active Comparator: Multiple-dose group
Ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure
Drug: Ceftazidime
These patients will be given ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure.




Primary Outcome Measures :
  1. Infectious complications associated with POEM [ Time Frame: From operation day to 4 weeks after the procedure ]
    Including regional, remote and systemic infections.


Secondary Outcome Measures :
  1. Pathogens for causing infection [ Time Frame: From operation day to 4 weeks after the procedure ]
    Body fluid will be collected and cultured in patients suspected of infectious complications

  2. Adverse effects of antibiotics [ Time Frame: From operation day to 4 weeks after the procedure ]
    Any adverse events related to ceftazidime will be recorded.

  3. Clavien-Dindo classification of surgical complications [ Time Frame: From operation day to 4 weeks after the procedure ]
    Clavien-Dindo classification of surgical complications is recorded if adverse events happen related to POEM

  4. Length of hospital stay [ Time Frame: From admission to discharge ]
    Length of hospital stay will be extracted.

  5. Efficacy of POEM [ Time Frame: admission to 4 weeks after POEM ]
    Eckardt score will be compared before and after POEM.Clinical scoring system for achalasia (Eckardt score) Score Symptom Weight loss (kg)(0-3), Dysphagia(0-3), Retrosternal pain(0-3), Regurgitation(0-3)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed of esophageal achalasia
  • Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests

Exclusion Criteria:

  • Patients with ASA score ≥3
  • Patients with indications for antibiotic prophylaxis(infective endocarditis or other conditions) as determined by the American Society for Gastrointestinal Endoscopy
  • Patients who have received antibiotics in the past seven days
  • Patients who have possible signs of infection during preparation for POEM
  • Pregnant
  • Immunodeficient patients such as severe neutropenia(<0.5x1068/l) and/or advanced hematological malignancy
  • Under steroid therapy
  • Patients who develop intraoperative severe adverse events including severe choking and aspiration during endotracheal intubation requiring antibiotic treatment as well as severe pneumothorax, perforation, bleeding and mucosal injury cannot be closed by clips.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404739


Locations
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China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Ping-Hong Zhou, MD, PhD Zhongshan Hospital, Fudan University, Shanghai, China
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03404739    
Other Study ID Numbers: ABX for POEM
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Antibiotic prophylaxis
Infectious complications
Peroral endoscopic myotomy
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents