Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Esophagus Cancer Clinical Trial

— Supercharged  

Official title:

Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954702
• Other study ID #: NP 1683
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: October 2026

Study information

• Verified date: June 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Flavio Takeda, PhD, MD
• Phone: +55 11 999079973
• Email: flavio.takeda[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

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.
• Conventional Esophagectomy
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo (ICESP)	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence and number of post-operatory complications	surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization	Until 1 year after Surgery
Primary	Mortality	Patients who and when died	Until 1 year after surgery after surgery
Secondary	Days in 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
Secondary	Hospitalization period	Number of days patient will stay in hospital after surgery	From the surgery day until the date patient leave hospital
Secondary	Need of vasoactive drugs	If patient use vasoactive drugs drugs hospitalization	From the surgery day until the date patient leave hospital
Secondary	Blood transfusion need	If patients need blood transfusion during hospitalization	From the surgery day until the date patient leave hospital
Secondary	Drain use time	How long patient use drain	From the surgery day until the date patient took off drain