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Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Sponsor: National Cancer Center, Korea
Summary
This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical applicability of Middle Segmental Gastrectomy (MSG) for patients with gastric cancer * MSG is a function-preserving surgical technique that resects the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus) to minimize common postoperative issues such as dumping syndrome and nutritional deficiencies The primary objective of the study is to determine the incidence of dumping syndrome at 1 year postoperatively (defined as a Sigstad score ≥ 7) and evaluate if it differs significantly from the 15.8% incidence reported for standard laparoscopic distal gastrectomy (LDG) in the KLASS 04 study . The study targets adult patients with mid- or high-body gastric adenocarcinoma with a tumor size of 4 cm or less at clinical stages cT1N0/1M0 or cT2N0/1M0 (well or moderately differentiated) . Secondary evaluations include monitoring postoperative reflux symptoms, changes in nutritional indicators (such as weight and hemoglobin), quality of life (QOL) using EORTC QLQ-C30 and STO22, and 3-year recurrence-free and overall survival rates.
Official title: A Multicenter, Prospective, Single-arm Clinical Trial on the Feasibility of Middle Segmental Gastrectomy (MSG)
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2025-06-15
Completion Date
2028-12-31
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)
This is a function-preserving surgery that involves resecting the middle portion of the stomach while preserving the pylorus and the upper stomach (cardia and fundus) . The middle segment is resected with a minimum 2-3 cm margin from the tumor . Specific vascular branches are preserved, including the right and left gastroepiploic arteries . The lymph node dissection includes stations Nos. 1, 3, 4sb, 4d, 7, 8a, and 9, while omitting stations Nos. 5 and 6 . Reconstruction is performed using a modified delta-shaped anastomosis with a straight automated anastomosis machine under laparoscopy
Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG)
Intervention Name: Totally Laparoscopic Middle Segmental Gastrectomy (TLMSG) Description: The intervention is a function-preserving surgical procedure performed on adult patients (age ≥ 20) diagnosed with mid- or high-body gastric adenocarcinoma with a tumor size of 4 cm or less * Eligible clinical stages include cT1N0/1M0 (any differentiation) or cT2N0/1M0 (well or moderately differentiated) The specific surgical steps and extent include: Resection and Preservation: The middle segment of the stomach is resected while maintaining a minimum 2-3 cm resection margin from the tumor * To preserve digestive function and minimize dumping syndrome, the pylorus and the upper portion of the stomach (cardia and fundus) are preserved Vascular Preservation: Vascular branches along the lesser and greater curvature are spared, specifically the right gastroepiploic artery and the left gastroepiploic artery . Lymph Node (LN) Dissection: The extent of LN excision includes stations Nos. 1, 3, 4sb, 4d
Locations (1)
National Cancer Center, Korea
Goyang, Gyeonggido, South Korea