Esophageal AchalasiaNCT01750385
Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
A study testing no antibiotic prophylaxis and second-generation cephalosporin in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital.
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. 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?
- no antibiotic prophylaxis and second-generation cephalosporin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Aug 2013
- Phase
- Interventional
- 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
- Clinical diagnosis of esophageal achalasia
- Ready to have the treatment as POEM and no contraindication of POEM
- Ability to get informed consent
Who cannot join
- 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.
About this study
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.
Read the detailed 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.
- Conditions
- Esophageal Achalasia
- Being tested
- no antibiotic prophylaxis, second-generation cephalosporin
- Keywords
- Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no antibiotic prophylaxisDrug
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
second-generation cephalosporinDrug
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
| Study group | Role | What they receive |
|---|---|---|
| no antibiotic prophylaxis | Active comparator | These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. Receives: Drug: no antibiotic prophylaxis |
| second-generation cephalosporin | Active comparator | These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. Receives: Drug: second-generation cephalosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood culture positive incidence
To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
Measured: after 12 hours of POEM
Secondary outcomes (1)
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.
Measured: after 12 hours of POEM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping-Hong Zhou, M.D,PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750385
- Sponsor's protocol ID
- B2012-089
- Status last verified
- Dec 2012
- First submitted
- 20 Nov 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
- ClinicalTrials.gov ID
- NCT01750385
- Acronym / sponsor ID
- B2012-089
- Conditions
- Esophageal Achalasia
- Keywords
- Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no antibiotic prophylaxis | Active comparator | Drug: no antibiotic prophylaxisThese patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. |
| second-generation cephalosporin | Active comparator | Drug: second-generation cephalosporinThese patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of esophageal achalasia
- Ready to have the treatment as POEM and no contraindication of POEM
- Ability to get informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no antibiotic prophylaxisThese patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically. | Drug | no antibiotic prophylaxis |
| second-generation cephalosporinThese patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically. | Drug | second-generation cephalosporin |
Primary outcome
Blood culture positive incidence
Time frame: after 12 hours of POEM
To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
1 secondary outcome
procalcitonin level
Time frame: after 12 hours of POEM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Hong Zhou, M.D,PhD study director
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing no antibiotic prophylaxis and second-generation cephalosporin in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 4 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Blood culture positive incidence (time frame: after 12 hours of POEM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2012.