Evaluating a new surgical technique for esophageal cancer reconstruction
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
This study is testing a new surgical method to see if it can help reduce complications for patients with esophageal cancer who are having surgery to reconstruct their esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05954702 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a supercharged TRAM flap transfer in reducing complications related to anastomotic ischemia in patients undergoing esophagectomy for esophageal cancer. The study compares outcomes between patients receiving conventional esophagectomy and those receiving the supercharged TRAM technique. Participants will be randomized and monitored for post-operative complications, aiming to improve tissue blood perfusion and decrease morbidity rates associated with esophageal reconstruction. The trial is conducted at the Instituto do Câncer do Estado de São Paulo.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with esophageal malignancy who can understand and collaborate during treatment.
Not a fit: Patients with a history of previous gastrectomy or surgeries that may alter stomach or cervical vascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative complications and improve recovery for patients undergoing esophagectomy.
How similar studies have performed: While there have been studies on vascularization techniques in esophageal reconstruction, the specific application of supercharged TRAM flaps in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
São Paulo, São Paulo
- Instituto do Cancer do Estado de São Paulo (ICESP) — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Flavio Takeda, PhD, MD — Instituto do Cancer do Estado de São Paulo
- Study coordinator: Flavio Takeda, PhD, MD
- Email: flavio.takeda@hc.fm.usp.br
- Phone: +55 11 999079973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.