Foregut Leaks-Role of Microbiome

Baylor Research Institute50 enrolled

Overview

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

For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gastrointestinal Diseases

Interventions

Biopsy and fluid samplesOTHER

Biopsy and fluid samples taken during other medically necessary procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with an esophageal or stomach leak * Over 18 years old Exclusion Criteria: * Patients determined by physician/surgeon as not able to tolerate biopsy * Under 18 years old

Locations (1)

Baylor Scott & White Center for Advanced Surgery

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Microbial composition of samples

change in virulence factors, microbial response to treatment modalities

Time frame: During the surgery

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)

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-surgery

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-surgery

Secondary Outcomes

Patient demographics

age, sex, race, ethnicity

Time frame: Baseline or anytime before surgery

Patient risk of postoperative complications

Calculated by ACS risk calculator

Time frame: Post surgery until the time leak is healed ( up to 24 weeks)

Central Contacts

Rehma Shabbir

CONTACT

2148201722 Rehma.Shabbir@BSWHealth.org

Data from ClinicalTrials.gov

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