In a groundbreaking initiative poised to influence the future of gastric cancer treatment, an international team of researchers has launched a large-scale, multicenter randomized controlled trial investigating the impact of perioperative probiotic supplementation on patients undergoing minimally invasive radical gastrectomy following neoadjuvant chemotherapy (NACT). This pioneering study aims to explore how probiotics might affect short-term clinical outcomes and recovery rates in this vulnerable patient population, potentially reshaping postoperative care protocols globally.
Gastric cancer remains a formidable adversary in oncology, ranking among the most common and lethal malignant tumors worldwide. Surgical removal of the stomach, primarily through radical gastrectomy, is widely regarded as the cornerstone for curative treatment, significantly enhancing long-term survival rates. However, for patients diagnosed at an advanced stage, neoadjuvant chemotherapy has become a vital preoperative intervention intended to downstage tumors and eradicate micrometastases, thereby improving surgical outcomes. Yet, this approach is not without its complications.
Neoadjuvant chemotherapy, while effective, is notorious for its adverse effects on intestinal integrity and the gut microbiome. Disruption of the gut barrier and dysbiosis can predispose patients to postoperative infections, delayed gastrointestinal recovery, and systemic inflammatory responses, which altogether may compromise surgical success and patient quality of life. Despite the critical role of gut health in postoperative recovery, there remains a paucity of high-quality clinical data evaluating interventions that might mitigate these negative effects.
Probiotics have long been recognized for their potential to restore intestinal homeostasis, modulate immune function, and fortify the gut barrier. Prior smaller-scale studies have hinted at their capacity to reduce infection rates and promote gastrointestinal function following various abdominal surgeries. However, robust evidence from large, rigorously designed clinical trials specifically focused on gastric cancer patients receiving neoadjuvant chemotherapy has been lacking – a gap this new study ambitiously seeks to fill.
The GISSG 2023–01 study protocol outlines a prospective, open-label, multicenter randomized controlled trial enrolling a total of 318 patients who are scheduled for laparoscopic or robotic radical gastrectomy after undergoing neoadjuvant chemotherapy. Participants will be randomly assigned in equal numbers to either a probiotic supplementation group or a control group receiving standard perioperative care without probiotic intervention. Importantly, the probiotic administration commences from the completion of the last chemotherapy cycle until postoperative day seven or discharge, aiming to maximize its protective effects during the critical perioperative period.
The primary endpoint of this trial is the incidence of postoperative infections, a major determinant of morbidity, prolonged hospital stay, and increased healthcare costs. Secondary outcomes extend to measuring the recovery trajectory of gastrointestinal function, patients’ quality of life, and laboratory markers indicative of systemic inflammation. By holistically assessing these parameters, the researchers hope to delineate a comprehensive picture of probiotic efficacy in this specialized clinical context.
Methodologically, the study’s open-label design acknowledges practical challenges in blinding probiotics and includes robust randomization to mitigate bias. The inclusion of multiple high-volume surgical centers enhances the generalizability of findings while ensuring adherence to standardized surgical and perioperative management protocols across cohorts, further strengthening the validity of outcomes.
This research addresses a crucial clinical question with significant implications. If perioperative probiotics demonstrate a tangible reduction in postoperative infections and accelerated gastrointestinal recovery, it could prompt paradigm shifts in managing gastric cancer patients undergoing complex surgical interventions post-chemotherapy. Enhanced recovery protocols integrating microbiota-focused therapies may become standard, improving patient experiences and resource utilization worldwide.
Another innovative aspect of this trial is its focus on minimally invasive surgical techniques – laparoscopic and robotic gastrectomy – which have increasingly supplanted traditional open surgeries due to their association with reduced trauma and faster recovery. Investigating probiotic supplementation in this contemporary surgical context underscores the study’s relevance to modern clinical practice.
The exploration of systemic inflammation markers within the trial is particularly noteworthy. Given the growing recognition of inflammation’s role in cancer progression and postoperative complications, understanding how probiotics modulate inflammatory pathways may unveil novel therapeutic targets and refine precision medicine approaches for gastric cancer care.
Moreover, the trial’s comprehensive quality of life assessments underscore a patient-centered research philosophy. Beyond focusing solely on biomedical endpoints, evaluating how probiotic supplementation influences patients’ subjective well-being ensures that findings will resonate meaningfully with clinicians and patients alike.
Looking forward, the GISSG 2023–01 study promises to generate high-quality evidence that can bridge existing knowledge gaps and catalyze further research into microbiome interventions across oncology and surgical disciplines. Positive results could also inspire investigations into similar probiotic applications for other malignancies and treatment modalities, potentially impacting a broad spectrum of cancer care pathways.
The urgency and significance of this trial are amplified by the rising global burden of gastric cancer and the increasing adoption of neoadjuvant treatment protocols. As surgical outcomes remain intricately tied to perioperative management strategies, integrating non-pharmacological adjuncts such as probiotics represents an exciting and cost-effective avenue to optimize patient recovery and survival.
In conclusion, this ambitious multicenter randomized controlled trial stands at the forefront of an emerging interdisciplinary frontier, blending surgical oncology, microbiome science, and immunology. Its outcomes hold the promise of refining postoperative care paradigms, alleviating infection-related complications, and ultimately improving quality of life for countless patients facing gastric cancer surgery after chemotherapy.
The scientific community eagerly awaits the publication of the GISSG 2023–01 study results, which will contribute vital insights into the role of probiotics in perioperative medicine. Should the hypotheses prove correct, this research will not only validate a novel therapeutic strategy but also inaugurate a new era of microbiota-centered interventions tailored to complex oncological surgeries.
Given the trial’s scale, rigorous methodology, and clinical relevance, it has the potential to become a landmark study, shaping future guidelines and inspiring a reevaluation of gut microbiota management in surgical oncology worldwide.
Trial information and details about patient enrollment have been registered and made publicly accessible on ClinicalTrials.gov under the identifier NCT05901779, fostering transparency and facilitating collaboration among researchers and clinicians globally.
This investigation exemplifies the dynamic evolution of cancer treatment toward integrative approaches that harness the body’s microbiome to enhance resilience, reduce complications, and empower patients throughout their therapeutic journey.
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Subject of Research: Effect of perioperative probiotic supplementation on short-term clinical outcomes in gastric cancer patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy.
Article Title: Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study).
Article References: Liu, G., Cao, S., Liu, X. et al. Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study). BMC Cancer 25, 776 (2025). https://doi.org/10.1186/s12885-025-14115-x
Image Credits: Scienmag.com
DOI: https://doi.org/10.1186/s12885-025-14115-x
