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Clinical Trials in Brazil / NCT05954702
Recruiting Not applicable

Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

NCT05954702 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2023-07-21
Last updated
2023-10-16

Condition(s) studied

Esophagus CancerCarcinoma Esophagus

Investigational drug(s) / intervention(s)

Supercharged TRAM esophagectomyConventional Esophagectomy

Supercharged TRAM esophagectomy: Esophagectomy, immediately followed by supercharged esophagogastroplasty. Use the transverse rectus abdominis myocutaneous (TRAM) flap transfers to surgically create a new anastomosis in the left gastroepiploic vessels.

Conventional Esophagectomy: Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.

Study summary

Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis.

Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of esophageal malignancy cancer; * Ability to understand and collaborate during treatment; Exclusion Criteria: * Previous gastrectomy; * Previous abdominal surgery with risk of altering stomach vascularization; * Previous head and neck surgery with risk of alteration of cervical vessels.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Instituto do Cancer do Estado de São Paulo (ICESP) São Paulo São Paulo Recruiting

More Instituto do Cancer do Estado de São Paulo trials in Brazil

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05954702 on ClinicalTrials.gov ↗ ← All trials in Brazil