Clinical trial NCT05954702: Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Official title: Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophagus Cancer
Carcinoma Esophagus
Keywords: Esophagectomy
Esophagogastroplasty
Supercharged
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Presence and number of post-operatory complications
timeFrame: Until 1 year after Surgery
measure: Mortality
timeFrame: Until 1 year after surgery after surgery
Secondary outcomes:
measure: Days in intensive care unit
timeFrame: From the surgery day until the date patient leave intensive care unit
measure: Hospitalization period
timeFrame: From the surgery day until the date patient leave hospital
measure: Need of vasoactive drugs
timeFrame: From the surgery day until the date patient leave hospital
measure: Blood transfusion need
timeFrame: From the surgery day until the date patient leave hospital
measure: Drain use time
timeFrame: From the surgery day until the date patient took off drain
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo (ICESP)
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Flavio Takeda, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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