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

NCT03404739 | Unknown Phase 2 DMC

• 1 other identifier: ABX for POEM
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Achalasia

Keywords

Antibiotic prophylaxis; Infectious complications; Peroral endoscopic myotomy

Outcome Measures

Primary Outcomes (1)

• Infectious complications associated with POEM

  Including regional, remote and systemic infections.

  From operation day to 4 weeks after the procedure

Secondary Outcomes (5)

• Pathogens for causing infection

  From operation day to 4 weeks after the procedure

• Adverse effects of antibiotics

  From operation day to 4 weeks after the procedure

• Clavien-Dindo classification of surgical complications

  From operation day to 4 weeks after the procedure

• Length of hospital stay

  From admission to discharge

• Efficacy of POEM

  admission to 4 weeks after POEM

Study Arms (2)

Single-dose group

EXPERIMENTAL

Ceftazidime 2g at the start of POEM

Drug: Saline Solution

Multiple-dose group

ACTIVE COMPARATOR

Ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure

Drug: Ceftazidime

Interventions

Saline Solution DRUG

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.

Single-dose group

Ceftazidime DRUG

These patients will be given ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure.

Multiple-dose group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (6)

• Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3.

  PMID: 23549760 BACKGROUND

• Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.

  PMID: 20354937 BACKGROUND

• Imamura H, Kurokawa Y, Tsujinaka T, Inoue K, Kimura Y, Iijima S, Shimokawa T, Furukawa H. Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: a phase 3, open-label, randomised controlled, non-inferiority trial. Lancet Infect Dis. 2012 May;12(5):381-7. doi: 10.1016/S1473-3099(11)70370-X. Epub 2012 Jan 31.

  PMID: 22297080 BACKGROUND

• ASGE Standards of Practice Committee; Khashab MA, Chithadi KV, Acosta RD, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Cash BD. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81(1):81-9. doi: 10.1016/j.gie.2014.08.008. Epub 2014 Nov 11. No abstract available.

  PMID: 25442089 BACKGROUND

• Mohri Y, Tonouchi H, Kobayashi M, Nakai K, Kusunoki M; Mie Surgical Infection Research Group. Randomized clinical trial of single- versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery. Br J Surg. 2007 Jun;94(6):683-8. doi: 10.1002/bjs.5837.

  PMID: 17514671 BACKGROUND

• Zhang XC, Li QL, Xu MD, Chen SY, Zhong YS, Zhang YQ, Chen WF, Ma LL, Qin WZ, Hu JW, Cai MY, Yao LQ, Zhou PH. Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis. Endoscopy. 2016 Nov;48(11):967-978. doi: 10.1055/s-0042-110397. Epub 2016 Jul 22.

  PMID: 27448052 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Saline Solution; Ceftazidime

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ping-Hong Zhou, MD, PhD

  Zhongshan Hospital, Fudan University, Shanghai, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered, opaque sealed envelopes(SNOSE) will be the method to conceal allocation from the study team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single- versus multiple-dose antimicrobial prophylaxis

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 19, 2018
• Study Start: October 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 7, 2018

Record last verified: 2018-01

Locations

CN (1)