AzTrials
AzTrials

Esophageal AchalasiaPhase 2/3NCT03404739

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

A Phase 2/3 study testing Saline Solution and Ceftazidime in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Achalasia
What is being tested?
Saline Solution and Ceftazidime
Could I receive a placebo?
No, everyone receives an active treatment
How many people
666 participants
Where
1 siteChina
Study dates
1 Oct 2017to Jan 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Saline Solution, Ceftazidime
Keywords
Antibiotic prophylaxis, Infectious complications, Peroral endoscopic myotomy
Medical subject headings
Esophageal Achalasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saline SolutionDrug

    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.

  • CeftazidimeDrug

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

Study groups in NCT03404739
Study groupRoleWhat they receive
Single-dose groupExperimentalCeftazidime 2g at the start of POEM
Receives: Drug: Saline Solution
Multiple-dose groupActive comparatorCeftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure
Receives: Drug: Ceftazidime

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infectious complications associated with POEM

    Including regional, remote and systemic infections.

    Measured: From operation day to 4 weeks after the procedure

Secondary outcomes (5)

  1. Pathogens for causing infection

    Body fluid will be collected and cultured in patients suspected of infectious complications

    Measured: From operation day to 4 weeks after the procedure

  2. Adverse effects of antibiotics

    Any adverse events related to ceftazidime will be recorded.

    Measured: From operation day to 4 weeks after the procedure

  3. Clavien-Dindo classification of surgical complications

    Clavien-Dindo classification of surgical complications is recorded if adverse events happen related to POEM

    Measured: From operation day to 4 weeks after the procedure

  4. Length of hospital stay

    Length of hospital stay will be extracted.

    Measured: From admission to discharge

  5. Efficacy of 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)

    Measured: admission to 4 weeks after POEM

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start1 Oct 2017
  3. Primary completionDec 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
single- versus multiple-dose antimicrobial prophylaxis
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
666 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404739
Sponsor's protocol ID
ABX for POEM
Status last verified
Jan 2018
First submitted
8 Jan 2018
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23549760

  • 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.

    PubMed 20354937

  • 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.

    PubMed 22297080

  • 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.

    PubMed 25442089

  • 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.

    PubMed 17514671

  • 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.

    PubMed 27448052

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Saline Solution and Ceftazidime in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infectious complications associated with POEM (time frame: From operation day to 4 weeks after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404739, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in