Foregut Leaks-Role of Microbiome
ConditionGastrointestinal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute
About this trial
Aims
1. To understand the microbial composition involved with foregut leaks 2. To define the virulence changes in the microbiota following foregut leaks 3. To identify host response mechanisms and how they change with interventions 4. Utilize this information to improve patient outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with an esophageal or stomach leak
Over 18 years old
Disqualifiers
Patients determined by physician/surgeon as not able to tolerate biopsy
Under 18 years old
Trial design
Design model
Single group
Treatments tested in this trial
Biopsy and fluid samples
Other interventionBiopsy and fluid samples taken during other medically necessary procedure
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Sample collectionOther 1 intervention
Trial outcomes
Primary outcomes
1
Microbial composition of samples
change in virulence factors, microbial response to treatment modalities
Time frame
During the surgery2
Time of healing of leaks
Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.
Time frame
From index intervention until documented leak resolution ( up to 24 weeks)3
Proportion of patients achieving leak closure without need for additional surgical intervention
Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.
Time frame
Up to 24 weeks post-surgery4
Incidence of postoperative complications
Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.
Time frame
Within 30 days post-surgerySecondary outcomes
1
Patient demographics
age, sex, race, ethnicity
Time frame
Baseline or anytime before surgery2
Patient risk of postoperative complications
Calculated by ACS risk calculator
Time frame
Post surgery until the time leak is healed ( up to 24 weeks)Sponsors and contacts
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Source ClinicalTrials.gov