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Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05954702
Collaborator
(none)
60
Enrollment
2
Arms
38
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supercharged TRAM esophagectomy
  • Procedure: Conventional Esophagectomy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Presence and number of post-operatory complications [Until 1 year after Surgery]

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

  2. Mortality [Until 1 year after surgery after surgery]

    Patients who and when died

Secondary Outcome Measures

  1. Days in intensive care unit [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 [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 [From the surgery day until the date patient leave hospital]

    If patient use vasoactive drugs drugs hospitalization

  4. Blood transfusion need [From the surgery day until the date patient leave hospital]

    If patients need blood transfusion during hospitalization

  5. Drain use time [From the surgery day until the date patient took off drain]

    How long patient use drain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Instituto do Cancer do Estado de São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT05954702
Other Study ID Numbers:
  • NP 1683
First Posted:
Jul 20, 2023
Last Update Posted:
Jul 20, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Instituto do Cancer do Estado de São Paulo
Esophagectomy
Esophagogastroplasty
Supercharged
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Jul 20, 2023