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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.
BMJ Open
|October 31, 2022
Summary
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.
