Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of esophageal malignancy cancer;

• Ability to understand and collaborate during treatment;

Locations
Other Locations
Brazil
Instituto do Cancer do Estado de São Paulo (ICESP)
RECRUITING
São Paulo
Contact Information
Primary
Flavio Takeda, PhD, MD
flavio.takeda@hc.fm.usp.br
+55 11 999079973
Time Frame
Start Date: 2023-07-21
Estimated Completion Date: 2026-10
Participants
Target number of participants: 60
Treatments
Active_comparator: Conventional Esophagectomy group
Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Experimental: Supercharged TRAM esophagectomy group
Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov