HeJi hospital affiliated ChangZhi medical college
Changzhi, Shanxi, 046000, China
NCT Number: NCT06970327
With the development of laparoscopic technology, the surgical treatment of early gastric cancer (EGC) has shifted towards minimally invasive, precise, and function-preserving strategies. Totally laparoscopic distal gastrectomy (TLDG) and totally laparoscopic pylorus-preserving gastrectomy (TLPPG) are minimally invasive procedures. However, there is a lack of systematic evidence to directly compare their efficacies.
This study focuses on two fully laparoscopic techniques, TLDG and TLPPG, to address two key objectives: (1) whether TLPPG can avoid the long-term functional sequelae of TLDG while ensuring oncological safety, including complications (delayed gastric emptying, reflux, and dumping syndrome), postoperative quality of life (assessed via the PGSAS-37 scale), and survival outcomes; and (2) the balance between complications and survival in function-preserving surgery. The findings aim to provide critical technical parameters for individualized surgical decision-making in EGC.
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Notify Me18 year–85 year
All sexes
Observational
Changzhi, Shanxi, 046000, China
With the continuous advancement and innovation of laparoscopic technology, the surgical treatment paradigm for early gastric cancer (EGC) is undergoing a profound transformation, gradually evolving towards a more minimally invasive, precise, and function-preserving approach. In this context, Totally Laparoscopic Distal Gastrectomy (TLDG) and Totally Laparoscopic Pylorus-Preserving Gastrectomy (TLPPG) have emerged as two highly representative minimally invasive surgical procedures. Characterized by smaller incisions, reduced trauma, and relatively faster postoperative recovery, they have garnered extensive attention in the field of EGC treatment. However, despite their application in clinical practice, there is currently a lack of comprehensive and systematic evidence-based medical data that can directly and thoroughly compare their therapeutic effects.
This study will focus on these two advanced laparoscopic surgical techniques, TLDG and TLPPG, and conduct in-depth exploration around two core objectives. Firstly, it will evaluate whether TLPPG can effectively avoid the long-term functional sequelae potentially caused by TLDG while ensuring oncological safety. These sequelae include common complications such as delayed gastric emptying, reflux, and dumping syndrome. Additionally, the study will comprehensively assess patients' postoperative quality of life using the PGSAS-37 scale and further analyze the impact of the two surgical procedures on patients' survival outcomes. Secondly, it will delve into how to achieve the optimal balance between complication control and patients' survival benefits in function-preserving surgeries. Through rigorous data analysis and scientific demonstration, this study aims to provide crucial technical parameters and reliable decision-making bases for the formulation of personalized surgical plans for EGC patients, thereby promoting the development of minimally invasive treatment for early gastric cancer towards a more precise and efficient direction.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From surgery completion to 30 days post - operation
Incidence of postoperative complications classified by the Clavien-Dindo criteria, including rate of Infection, Anastomotic issues, and Delayed gastric emptying.
Time frame: Baseline
The age of the patient at the time of enrollment in the study.
Time frame: Baseline
The weight of the patient.
Time frame: Baseline
The height of the patient.
Time frame: Baseline
The body mass index of the patient, calculated as weight (kg) divided by height squared (m²).
Time frame: Intraoperative
The total volume of blood lost during the surgical procedure.
Time frame: Intraoperative
The total duration of the surgical procedure.
Time frame: Intraoperative
The total number of lymph nodes examined during the surgical procedure.
Time frame: Perioperative
The time elapsed from the end of the surgery until the patient experiences the first flatus.
Time frame: Perioperative
The time elapsed from the end of the surgery until the patient has the first bowel movement.
Time frame: Perioperative
The time elapsed from the end of the surgery until the patient is able to eat and drink normally.
Time frame: Perioperative
The total number of days the patient remains hospitalized after the surgical procedure.
Changzhi Medical College
Other
Comparative Study on the Efficacy of Totally Laparoscopic Distal Gastrectomy and Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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