Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Instituto do Cancer do Estado de São Paulo

Status: Enrolling

Conditions: Esophagus Cancer; Carcinoma Esophagus

Treatments: Procedure: Conventional Esophagectomy; Procedure: Supercharged TRAM esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05954702

NP 1683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional Esophagectomy group

Active Comparator group

Description:

Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.

Treatment:

Procedure: Conventional Esophagectomy

Supercharged TRAM esophagectomy group

Experimental group

Description:

Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.

Treatment:

Procedure: Supercharged TRAM esophagectomy