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Trial Title:
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
NCT ID:
NCT05954702
Condition:
Esophagus Cancer
Carcinoma Esophagus
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophagectomy
Esophagogastroplasty
Supercharged
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Supercharged TRAM esophagectomy
Description:
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.
Arm group label:
Supercharged TRAM esophagectomy group
Intervention type:
Procedure
Intervention name:
Conventional Esophagectomy
Description:
Esophagectomy, immediately followed by an esophagus reconstruction trough
esophagogastroplasty.
Arm group label:
Conventional Esophagectomy group
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.
Detailed description:
The transfer of muscle parts is one of the main reconstruction techniques used in plastic
surgery. Transverse rectus abdominis myocutaneous (TRAM) flap transfers are very
considered due to high quality results, wide application in many cases, and small number
of reviews in long term.
Beegle, in 1991 published a new technique of using TRAM supercharged in which
microsurgical anastomosis are used between TRAM's unipedicled gastroepiploic deep artery
and veins and thoracic branches and vessels, such as axillary and thoracodorsal vessels.
Looking for recover tissue blood perfusion and decrease morbidity rates associated with
anastomosis ischemia, some studies showed large intestine or jejunum interposition plus
an additional blood supply through venous and arterial anastomosis - colon or jejunum
supercharged is effective. The isoperistaltic supercharged colon interposition was a good
option to rebuild big esophagus parts in which stomach was not available.
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. This is a single-institution, randomized clinical trial with participants
recruited in the digestive system surgery clinic, at the Instituto do Câncer do Estado de
São Paulo (ICESP). Patients will be randomized to conventional esophagectomy or TRAM
supercharged esophagectomy, and researchers will evaluate post-operatory complications in
both groups.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Cancer do Estado de São Paulo (ICESP)
Address:
City:
São Paulo
Zip:
01246000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Flavio Takeda, MD
Investigator:
Last name:
Flavio Takeda, MD
Email:
Principal Investigator
Start date:
July 21, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954702
