Impact of Preserving Versus Ligating the Right Gastric Artery on Anastomotic Outcomes After McKeown Esophagectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of Cervical Anastomotic Leakage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
RGA Preservation Group
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.
Intervention: McKeown MIE with RGA Preservation (Procedure)
RGA Ligation Group
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.
Intervention: McKeown MIE with RGA Ligation (Procedure)
Outcomes
Primary Outcomes
Incidence of Cervical Anastomotic Leakage
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Operative Time(Day 1 (Day of Surgery))
- Lymph Node Yield(Day 1 (Day of Surgery))
Investigators
Yongbin Song
Principal investigator
The First Hospital of Hebei Medical University