Clinical trial NCT06970327: Totally Laparoscopic Distal Gastrectomy VS Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach
Official title: Comparative Study on the Efficacy of Totally Laparoscopic Distal Gastrectomy and Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrectomy
Lead sponsor: Changzhi Medical College
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 63 patients with TLDG and 32 with TLPPG were included. The two groups of patients had similar sex, age, body mass index (BMI), and preoperative hemoglobin and albumin levels.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Preoperative diagnosis of early gastric adenocarcinoma (invasion limited to the mucosa or submucosa) confirmed by tissue biopsy, abdominal enhanced CT, and endoscopic ultrasound;
* Tumor located in the gastric body or distal stomach, \>4 cm from the pylorus;
* Ineligible for endoscopic mucosal dissection or elected for surgical treatment by family;
* Complete clinical and pathological data.

Exclusion Criteria:

* Severe anemia, coagulation disorders, or gastric outlet obstruction;
* History of gastric or upper abdominal surgery;
* Concurrent malignant tumors, ascites, edema, or pleural effusion;
* Gastric ulcers, polyps, or intestinal metaplasia.

Primary outcomes:
measure: Complications
timeFrame: From surgery completion to 30 days post - operation
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight（Kilograms）
timeFrame: Baseline
measure: Height（Centimeters）
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Blood Loss（Milliliters）
timeFrame: Intraoperative
measure: Operation Time（Minutes）
timeFrame: Intraoperative
measure: Number of Examined Lymph Nodes
timeFrame: Intraoperative
measure: Time to Flatus
timeFrame: Perioperative
measure: Time to Defecation
timeFrame: Perioperative
measure: Time to Bite & Sup
timeFrame: Perioperative
measure: Hospital Stay Duration
timeFrame: Perioperative
Other outcomes:
Locations:
city: ChangZhi
country: China
facility: HeJi hospital affiliated ChangZhi medical college
state: Shanxi
Study officials:
References: