Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This randomized controlled trial evaluates the impact of preserving versus ligating the Right Gastric Artery (RGA) on postoperative anastomotic complications in patients undergoing McKeown minimally invasive esophagectomy (MIE) for esophageal squamous cell carcinoma. Specifically, the study compares the incidence of anastomotic leakage and stenosis between two groups of patients reconstructed with a 3cm-wide gastric conduit.
Detailed description
Anastomotic leakage (AL) and benign anastomotic stenosis (BAS) are critical complications following McKeown MIE. While the right gastroepiploic artery (RGEA) is the primary blood supply for the gastric conduit, the role of the Right Gastric Artery (RGA) remains controversial. Some evidence suggests preserving the RGA may improve perfusion to the proximal gastric conduit, potentially reducing ischemic complications. In this single-center prospective RCT, 120 eligible patients were randomized 1:1 into an RGA Preservation Group (Group A) and an RGA Ligation Group (Group B). Both groups underwent reconstruction with a narrow (3cm) gastric conduit. The study aims to provide evidence on whether RGA preservation improves hemodynamic outcomes as manifested by reduced leakage and stenosis rates.
Interventions
PROCEDUREMcKeown MIE with RGA Preservation
Patients in this arm underwent McKeown MIE where the stomach was mobilized while carefully preserving the main trunk of the right gastric artery (RGA). Lymph nodes along the lesser curvature (Station 3) were dissected by peeling them away from the vascular arcade.
PROCEDUREMcKeown MIE with RGA Ligation
Patients in this arm underwent McKeown MIE where the right gastric artery (RGA) was identified at its origin from the proper hepatic artery and ligated at the root to facilitate en bloc resection of Station 3 lymph nodes.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma of the middle or upper thoracic esophagus. * Candidates for elective McKeown minimally invasive esophagectomy (MIE). * Age 18-75 years. * Preoperative clinical stage I-IIIA (cT1-3N0-1M0) according to the AJCC/UICC 8th Edition TNM staging system.
Exclusion criteria
* Clinical stage IIIB or IV. * History of previous thoracic or abdominal surgery affecting the stomach or esophagus. * Neoadjuvant chemoradiotherapy (to eliminate confounding effects on tissue healing). * Severe comorbidities (e.g., uncontrolled diabetes, severe cardiopulmonary dysfunction, liver cirrhosis). * Intraoperative finding of unresectable tumor. * Conversion to open surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cervical Anastomotic Leakage | Up to 30 days postoperatively | Defined as the extravasation of contrast on esophagogram or the presence of saliva/gastric content in the cervical wound, often accompanied by fever or inflammatory signs. |
| Incidence of Anastomotic Stenosis (Early) | 2 months postoperatively | Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms. |
| Incidence of Anastomotic Stenosis (Late) | 4 months postoperatively | Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Day 1 (Day of Surgery) | The total duration of the surgical procedure measured in minutes. |
| Lymph Node Yield | Day 1 (Day of Surgery) | The total count of lymph nodes harvested during the surgery. |
Countries
China
Outcome results
None listed