Related Experiment Video
Updated: Aug 23, 2025
Single Incision Plus One Port Laparoscopic Proximal Gastrectomy with Double Channel Anastomosis for Gastric Cancer Treatment
Published on: December 27, 2024
Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial
Felix Nickel1, Alexander Studier-Fischer1, David Hausmann1
1Department of General, Visceral and Transplantation Surgery, UniversitätsKlinikum Heidelberg, Heidelberg, Germany.
Introduction:
The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG).
Methods And Analysis:
This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up.
Ethics And Dissemination:
Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access.
Trial Registration Number:
DRKS00025765.
Insights
This study compares minimally invasive total gastrectomy (MIG) to open total gastrectomy (OG) for gastric cancer treatment. It evaluates postoperative morbidity to determine if MIG offers a less invasive surgical option for patients.
Area of Science:
- Surgical Oncology
- Gastroenterology
- Clinical Trials
Background:
- Radical gastrectomy with D2 lymphadenectomy is the primary curative treatment for gastric cancer.
- Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity but lacks widespread adoption in Western countries.
Purpose of the Study:
- To compare the postoperative morbidity of minimally invasive total gastrectomy (MIG) versus open total gastrectomy (OG) in a Western multicenter randomized controlled trial (RCT).
Main Methods:
- A superiority multicenter RCT comparing MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+ lymphadenectomy.
- Includes 160 participants (80 per group) aged 18-84 with planned total gastrectomy for gastric carcinoma.
- Primary endpoint: 30-day postoperative morbidity (Comprehensive Complications Index); Secondary endpoints: morbidity, mortality, quality of life, oncological outcomes (R0 resection, survival).
Main Results:
- Data not yet available as recruitment is ongoing.
Conclusions:
- The study will provide crucial data on the safety and efficacy of minimally invasive total gastrectomy compared to open surgery for gastric cancer in a Western population.
