Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
NCT ID: NCT05954702
Last Updated: 2023-10-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-07-21
Study Completion Date
2026-10-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Esophagus Cancer
Carcinoma Esophagus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Conventional Esophagectomy
Intervention Type
PROCEDURE
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Supercharged TRAM esophagectomy group
Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.
Group Type
EXPERIMENTAL
Supercharged TRAM esophagectomy
Intervention Type
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.
Interventions
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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.
Intervention Type
PROCEDURE
Conventional Esophagectomy
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of esophageal malignancy cancer;
* Ability to understand and collaborate during treatment;
* 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.
* Previous abdominal surgery with risk of altering stomach vascularization;
* Previous head and neck surgery with risk of alteration of cervical vessels.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Flavio Takeda, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto do Cancer do Estado de São Paulo
Locations
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Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, São Paulo, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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Flavio Takeda, MD
Role: primary
References
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Other Identifiers
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NP 1683
Identifier Type: -
Identifier Source: org_study_id
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