Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05954702

Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Cancer do Estado de São Paulo (ICESP)

São Paulo, 01246000, Brazil

Location status: Recruiting

Location contact

Flavio Takeda, MD

CONTACT

Flavio Takeda, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supercharged TRAM esophagectomy

Procedure

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.

Conventional Esophagectomy

Procedure

Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.

Primary outcomes

  1. Presence and number of post-operatory complications

    Time frame: Until 1 year after Surgery

    surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization

  2. Mortality

    Time frame: Until 1 year after surgery after surgery

    Patients who and when died

Secondary outcomes

  1. Days in intensive care unit

    Time frame: From the surgery day until the date patient leave intensive care unit

    Number of days patient will stay at intensive care unit

  2. Hospitalization period

    Time frame: From the surgery day until the date patient leave hospital

    Number of days patient will stay in hospital after surgery

  3. Need of vasoactive drugs

    Time frame: From the surgery day until the date patient leave hospital

    If patient use vasoactive drugs drugs hospitalization

  4. Blood transfusion need

    Time frame: From the surgery day until the date patient leave hospital

    If patients need blood transfusion during hospitalization

  5. Drain use time

    Time frame: From the surgery day until the date patient took off drain

    How long patient use drain

Study contacts

Contact information is provided by the study sponsor or research team.

Flavio Takeda, PhD, MD

CONTACT

[email protected]

+55 11 999079973

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Acronym: Supercharged

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.