Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy (Supercharged)

October 13, 2023 updated by: Instituto do Cancer do Estado de São Paulo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01246000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo (ICESP)
        • Contact:
          • Flavio Takeda, MD
        • Principal Investigator:
          • Flavio Takeda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Esophagectomy group
Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Procedure: Conventional Esophagectomy
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Experimental: Supercharged TRAM esophagectomy group
Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.
Procedure: Supercharged 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until 1 year after Surgery
Mortality
Time Frame: Until 1 year after surgery after surgery
Patients who and when died
Until 1 year after surgery after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the surgery day until the date patient leave intensive care unit
Hospitalization period
Time Frame: From the surgery day until the date patient leave hospital
Number of days patient will stay in hospital after surgery
From the surgery day until the date patient leave hospital
Need of vasoactive drugs
Time Frame: From the surgery day until the date patient leave hospital
If patient use vasoactive drugs drugs hospitalization
From the surgery day until the date patient leave hospital
Blood transfusion need
Time Frame: From the surgery day until the date patient leave hospital
If patients need blood transfusion during hospitalization
From the surgery day until the date patient leave hospital
Drain use time
Time Frame: From the surgery day until the date patient took off drain
How long patient use drain
From the surgery day until the date patient took off drain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Flavio Takeda, PhD, MD, Instituto do Cancer do Estado de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 1683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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