Carcinoma Esophagus, Esophagus Cancer
Conditions
Keywords
Esophagectomy, Esophagogastroplasty, Supercharged
Brief 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.
Interventions
PROCEDURESupercharged 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.
PROCEDUREConventional Esophagectomy
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence and number of post-operatory complications | Until 1 year after Surgery | surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization |
| Mortality | Until 1 year after surgery after surgery | Patients who and when died |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of vasoactive drugs | From the surgery day until the date patient leave hospital | If patient use vasoactive drugs drugs hospitalization |
| Days in intensive care unit | From the surgery day until the date patient leave intensive care unit | Number of days patient will stay at intensive care unit |
| Drain use time | From the surgery day until the date patient took off drain | How long patient use drain |
| Blood transfusion need | From the surgery day until the date patient leave hospital | If patients need blood transfusion during hospitalization |
| Hospitalization period | From the surgery day until the date patient leave hospital | Number of days patient will stay in hospital after surgery |
Countries
Brazil
Contacts
Primary ContactFlavio Takeda, PhD, MD
Outcome results
None listed